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November 2020 www.clpmag.com
CLINICAL LAB PRODUCTS
Profiles in Leadership
From CEOs to Nobel laureates, women are making
their mark in the clinical sciences | 14
Current Challenges in Covid-19 Testing | 20
Better Controls for Covid-19 Diagnostics | 26
Fighting Antimicrobial-Resistant HAIs | 32
Flow Cytometry in Clinical Labs | 50
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14
Profiles in Leadership
From CEOs to Nobel laureates,
women are making their mark in
the clinical sciences
By Laurie Bonner
November 2020
www.clpmag.com
Editor’s Message | 4
Lab Notes | 6
Product Spotlight
Covid-19 Tests & Supplies | 44
12 Inside Track | The Virus That Took Over the World
The changes wrought by covid-19 may be felt for years to come
Interview by Laurie Bonner
20 Current Challenges in Covid-19 Testing
Where we are now, and what comes next
By Albino Troilo, PhD
26 Better Controls for Covid-19 Diagnostics
Engineered recombinant antibodies offer advantages over serum-based controls
By Michael Fiebig, PhD
32 Fighting Antimicrobial-Resistant HAIs
Diagnostics are key to preventing and controlling this growing global threat
Product News | 48
By Jean B. Patel, PhD D(ABMM)
35
Tech Guide | Calibrators, Controls, Reference Standards, and
Interlaboratory Peer-Reporting Programs
Audit MicroControls • Bio-Rad Laboratories • Biochemical Diagnostics
EuroTrol • Kova International •Maine Molecular Quality Controls
More Diagnostics • Quantimetrix • Qnostics • Randox Laboratories
Streck •Utak Laboratories • Verichem Laboratories
50 Flow Cytometry in Clinical Labs
Advancements in automation are poised to expand
the use of this technology
By Troy Rudzinski, MBA, MLS (ASCP), SCYM
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clpmag.com | November 2020 3
editor’smessage
Gender Matters
CLINICAL LAB PRODUCTS
Does gender matter when it comes to science?
LAURIE BONNER
We all know it shouldn’t, of course. Data and Chief Editor, CLP
reproducible results, by definition, need to be inde- lbonner@medqor.com Volume 50 | Number 8 | November 2020
©2020 MEDQOR LLC
pendent of the scientists who generate it. But we 410-730-4893
also all know that gender can make a huge differ-
MISSION STATEMENT
ence—in prevailing social attitudes, opportunities CLP, the product magazine for clinical lab professionals,
presented, recognitions awarded. provides product news and introductions, as well as
How many women over the years—such as chemist Rosalind Franklin editorial features that showcase breakthrough technologies,
and help improve testing and diagnostic procedures.
and physicist Jocelyn Bell Burnell—were passed by while Nobel Prizes were
awarded to their male colleagues? The good news is that the times, at last, seem
to be changing. Since the first Nobel Prizes were awarded in 1901, a grand total PRESIDENT, CLINICAL TESTING | Tim Owczarzak
of 58 in all categories have been given to women—and nearly half, 28, happened 630-561-3375; timo@medqor.com
since 2001.1
CHIEF EDITOR/PRINCIPAL ANALYST | Laurie Bonner
The prizes for chemistry and physics have been especially deficient in female
410-730-4893; lbonner@medqor.com
representation. In 2020, the Nobel for physics was awarded to a woman—Andrea
Ghez, PhD—for only the fourth time in history; also this year, Jennifer Doudna, ASSOCIATE EDITOR | Melanie Hamilton-Basich
PhD, and Emmanuelle Charpentier, PhD, inventors of CRISPR/Cas9, became the
ART DIRECTOR | Mamani Chinnaraj
sixth and seventh women to win the Nobel in chemistry.
Recognitions like this matter, in part because it helps to inspire new genera-
tions of young women to pursue careers in the sciences.
“I hope this award shows young women that a career in lab science is not only
a real possibility, but that the community wants them and needs them,” says
Doudna, in an interview with CLP. 7900 College Blvd.
To support that effort, CLP has profiled Doudna, along with six other women Suite 105
whose leadership and innovation are contributing to clinical lab sciences (see Overland Park, KS 66210
“Profiles in Leadership,” page 14). Their profiles stand alongside the work of 913-894-6923
MEDQOR.COM
two other highly accomplished women: Nancy Stratton, CEO of COLA (see “The
Virus That Took Over the World,” page 12), and Jean Patel, PhD (see “Fighting
Antimicrobial-Resistant HAIs,” page 32). OWNER/FOUNDER | Brian Weaver
Of course, the dominant headline of 2020 is still covid-19. Stratton’s interview
CHIEF EXECUTIVE OFFICER | Don Ransdell
along with Albino Troilo, PhD’s article, “Current Challenges in Covid-19 Testing”
(page 20), both explore the impact the pandemic has had on clinical labs, what CHIEF REVENUE OFFICER | John Squires
effects may become long-lasting or permanent, and what changes may still be to
come. Michael Fiebig, PhD’s “Better Controls for Covid-19 Diagnostics” (page 26) CHIEF TECHNICAL OFFICER | Jae Cha
describes the race to develop effective controls for covid-19 testing and research.
DIRECTOR, CONTENT | Sree Roy
What do you think?
DIRECTOR, MEDIA OPERATIONS | Tonya Manning
REFERENCE
1. Women Who Changed the World. The Nobel Foundation. Nobel Media AB 2020. Updated October 27, 2020. VP DIGITAL PRODUCTS | Eli Patterson
Available at www.nobelprize.org/prizes/lists/nobel-prize-awarded-women. Accessed October 27, 2020.
DIRECTOR, DATA OPERATIONS | Pam Ayers
EDITORIAL ADVISORY BOARD
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CRAIG C. FOREBACK, PHD
REPRINTS
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For reprints and licensing, please contact Tim Owczarzak
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Member, Digital Pathology Association Executive Board; Chair, NSH Quality Management Committee
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4 November 2020 | clpmag.com
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labnotes
Siemens, CDC Collaborating to Define Threshold for
Covid-19 Immunity
Siemens Healthineers announced a col-
laboration with the United States Centers
for Disease Control and Prevention (CDC)
and the JRC (Joint Research Centre) of the
European Commission on a research project
to develop a novel process for standardizing
SARS-CoV-2 assays.
Antibody tests differ among test manu-
facturers and currently cannot be analyti-
cally compared because they target different
SARS-CoV-2 proteins. These include the spike
Digital pathology at Singapore General Hospital. Photo protein, S1/S2, S1 RBD, and N protein, which
courtesy Philips. are found in different parts of the SARS-CoV-2
virus. As the pandemic has evolved, antibody
Philips, Singapore General Hospital to test results have progressed from qualita- Headquarters of the Centers
Establish Digital and Computational tive positive/negative results to more recent for Disease Control and
assays capable of numerical measurements Prevention. Photo courtesy
Pathology Center of Excellence that gauge the level of IgG antibodies in a Dreamstime.
Royal Philips, Amsterdam, announced a collaboration patient’s blood sample.
with Singapore General Hospital (SGH) to establish the The reportable numerical patient results of the current semiquantitative
Singapore General Hospital Digital and Computational assays are expressed in units that are not actual concentrations of antibod-
Pathology Center of Excellence. The SGH Center of ies, but rather the antibody activity to the virus. Because comparing test
Excellence aims to advance pathology practice by results across manufacturers has not been possible, establishing immunity
implementing a fully digital histopathology workflow associated with these tests has been challenging. Siemens Healthineers’
and deploying artificial intelligence (AI) to increase collaboration with the CDC and the JRC will develop a novel process for
productivity and enhance patient care. standardizing SARS-CoV-2 assays by anchoring each protein to a neutraliza-
Located within SGH’s Division of Pathology, one of tion antibody titer—a level of antibody present to block virus from entering
the largest pathology laboratories in ASEAN, the Center cells in laboratory experiments.
of Excellence aims to establish ASEAN’s first fully digi-
tized histopathology laboratory by expanding its digital
pathology capabilities for primary diagnosis, training,
and research with the Philips IntelliSite Pathology
Solution. Both SGH and Philips will also work closely Global Partnership to Offer 120 Million Covid-19
on other diverse areas, including streamlining of the Rapid Tests for Low- and Middle-Income Countries
histopathology laboratory’s digital workflow. The Access to Covid-19 Tools (ACT) Accelerator—a global collaboration
As in other parts of the world, the demand for cancer to accelerate the development, production, and equitable access to covid-19
diagnosis in Singapore is increasing while pathologists tests, treatments, and vaccines that includes the World Health Organization,
remain scarce. A recent study, conducted by SGH and the European Commission, and the Bill & Melinda Gates Foundation—has
Philips, revealed that full digitization of SGH’s histopa- announced a set of agreements to make affordable, high-quality covid-19
thology laboratory will improve efficiency. It has the antigen rapid tests available for low- and middle-income countries (LMICs).
potential to enable time savings in the pathology work- As part of this comprehensive effort, the Bill & Melinda Gates Foundation
flow and allow the pathology department to increase has executed separate volume guarantee agreements with rapid diagnostic
its capacity by another 7% while retaining the same test (RDT) producers Abbott, Chicago, and South Korea-based SD Biosensor.
number of employees. These two arrangements will make available to LMICs 120 million antigen
Through optimization of digital pathology at SGH, rapid diagnostic tests (Ag RDTs)—priced at a maximum of $5 per unit—over
the hospital will be able to further its research in AI. a period of 6 months. These tests provide results in 15 to 30 minutes and
AI-based tools can aid pathologists in diagnosing dis- will enable expansion of testing, particularly in countries that do not have
eases such as cancer—the leading cause of mortality extensive laboratory facilities or trained health workers to implement molecu-
in Singapore—and empower them to face the current lar tests.
challenges in pathology. The increasing number of The tests developed by Abbott and SD Biosensor are highly portable, reli-
cancer cases, an aging population, and rapid advances able, and easy to administer, making testing possible in near-person, decen-
in personalized medicine have resulted in significant tralized healthcare settings. Both companies’ tests are faster and cheaper
complexity of pathological diagnostics, adding to the than laboratory-based tests, enabling countries to increase the pace of test-
workload of pathologists. AI will allow pathologists to ing, tracing, and treating people for covid-19 at the point of care particularly in
focus more on challenging tasks and unusual cases areas with under-resourced health systems. A number of other Ag RDTs are at
that require a higher degree of expertise and skills. various stages of development and assessment.
6 November 2020 | clpmag.com
labnotes
Significant Step Toward Blood Test for Alzheimer’s Disease
Researchers at Washington University School of Medicine in St. Louis have developed a
technique to detect minute amounts of a protein fragment linked to Alzheimer’s disease
in the blood. The study shows that levels of p-tau-217 are elevated during the early stages
of Alzheimer’s disease and could lead to a simple blood test capable of diagnosing the
neurodegenerative disorder years before any symptoms begin to appear.1
Randall Bateman, Nicolas Barthélemy, and colleagues at Washington University School
of Medicine in St. Louis previously found that a modified fragment of tau, known as p-tau-
217, accumulates in the cerebrospinal fluid of Alzheimer’s patients before the onset of
cognitive symptoms, increases with disease progression, and can accurately predict the
formation of amyloid plaques. The researchers suspected that p-tau-217 might also be
present in the blood of Alzheimer’s patients, albeit at very low levels that would make it
difficult to detect.
Barthélemy and colleagues developed a mass spectrometry-based method to measure
the amount of p-tau-217 and other tau fragments in as little as 4 ml of blood, even though
such small samples may contain less than a trillionth of a gram of p-tau-217.
The researchers found that, similar to p-tau-217 levels in cerebrospinal fluid, p-tau-217
levels in the blood were extremely low in healthy volunteers but elevated in patients with
amyloid plaques, even in those who had yet to develop cognitive symptoms.
REFERENCE
1. Barthélemy NR, Horie K, Sato C, Bateman RJ. Blood plasma phosphorylated-tau isoforms track CNS change in Alzheimer’s
Photo © Katarzyna Bialasiewicz, Dreamstime.com. disease. J Exp Med. 2020;217(11):e20200861. doi:1084/jem.20200861.
New CPT Codes for Covid-19 Multivirus Tests NASA Creates Breath Analyzer to
The American Medical Association (AMA) has published an update Diagnose Multiple Illnesses
to the Current Procedural Terminology (CPT) code set that includes The National Aeronautics and Space Administration (NASA)
new code additions and editorial revisions for reporting medical representatives presented new medical diagnostic technol-
services sparked by the public health response to the covid-19 ogy, the E-Nose Breathanalyzer, to members of David Grant
pandemic. USAF Medical Center Oct. 21, 2020, at Travis Air Force Base.
The update to the CPT code set was approved by the CPT Editorial The E-Nose Breathanalyzer, under development at NASA’s
Panel, the independent body convened by the AMA with authority to Ames Research Center in Silicon Valley, will have the capabil-
review and approve proposed additions and revisions to the CPT code ity of analyzing compounds found within a person’s breath to
set. The new additions and revisions to the CPT code set have been diagnose a battery of illnesses and abnormalities including
approved for immediate use. respiratory illnesses, infectious diseases, and cardiovascular
“Two of the newly approved codes report nucleic acid assays that conditions. As the science continues to be explored, the
allow a single test to simultaneously detect the novel coronavirus and breath analyzer may one day be used to diagnose cancer.
a combination of common viral infectious agents, including influenza Travis AFB Airmen are hosting the NASA technology and col-
A/B and respiratory syncytial virus,” says AMA President Susan R. laborative research at the DGMC clinical investigation facility.
Bailey, MD. “Concurrent detection promises to conserve important “The technology is designed to make rapid measurements,
testing resources, allowing for ongoing surveillance of influenza in less than 5 minutes, at the point of care, in a way that
while testing for the novel coronavirus.” is completely noninvasive. When fully realized, the NASA
For quick reference, the new category I CPT codes and long descrip- E-Nose will open a new realm of medical care to both the
tors are: warfighter and potential space travelers,” says David Loftus,
87636. Infectious agent detection by nucleic acid (DNA or RNA); MD, PhD, NASA Ames Research Center medical officer and
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) principal investigator of the Space Biosciences Research
(Coronavirus disease [COVID-19]) and influenza virus types A and B, Branch.
multiplex amplified probe technique “The technology itself is handheld,” Loftus says. “This
87637. Infectious agent detection by nucleic acid (DNA or RNA); makes it valuable not only to the U.S. Air Force during aero-
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) medical evacuation, but also to NASA, as a tool for monitor-
(Coronavirus disease [COVID-19]), influenza virus types A and B, and ing the health of astronauts far from medical centers on
respiratory syncytial virus, multiplex amplified probe technique. Earth. Human exploration of space, to the Moon and Mars,
The CPT Editorial Panel also revised CPT codes ranging from will require compact medical diagnostics technologies that
87301 to 87430 by removing the undefined term “multi step method” can be ruggedized for field use. The Air Force and other
from code descriptors. branches of the military share this requirement.”
clpmag.com | November 2020 7
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labnotes
Prototype Device Lets Patients Monitor Their Own
Blood for Cancer Biomarkers
Researchers at McMaster and Brock universities
have created the prototype for a handheld device
to measure a biomarker for cancer, paving the way
for home-based cancer monitoring and to improve
access to diagnostic testing.1
The device works much like the monitors that
people with diabetes use to test their blood-sugar lev-
els and could be used in a medical clinic or at home, The handheld
all without labwork, greatly simplifying the process device measures a
for testing blood for cancer’s signature. biomarker for cancer,
A user would mix a droplet of blood in a vial of paving the way for
reactive liquid, then place the mixture onto a strip and home-based cancer
monitoring. Photo
insert it into a reader. In minutes, the device would
Glioma tumor with diseased tissue. Photo © Dr. Norbert courtesy McMaster
Lange, Dreamstime.com measure an antigen that indicates the degree to University.
which cancer is present.
The prototype has been designed to monitor prostate specific antigen
Breakthrough Blood Test Developed (PSA), and the technology can readily be adapted to measure other markers,
for Brain Tumors depending on the form of cancer or other chronic disease.
Genetic mutations that promote the growth of the “This is another step toward truly personalized medicine,” says
most common type of adult brain tumors can be McMaster’s Leyla Soleymani, a biomedical engineer and Canada Research
accurately detected and monitored in blood samples Chair in Miniaturized Biomedical Devices. “We’re getting away from central-
using an enhanced form of liquid biopsy developed by ized, lab-based equipment for this kind of testing. This would make monitor-
researchers at Massachusetts General Hospital.1 ing much more accessible and cut down on the number of times patients
Comparing blood samples from patients with glio- need to leave home to provide blood samples.”
mas with tumor biopsy tissues from the same patients,
REFERENCE
Leonora Balaj, PhD, Bob S. Carter, MD, and other MGH 1. Traynor SM, Wang GA, Pandey R, Li F, Soleymani L. Dynamic bio‐barcode assay enables electrochemi-
investigators in the Department of Neurosurgery found cal detection of a cancer biomarker in undiluted human plasma: a sample‐in‐answer‐out approach. Angew
Chem Int Ed Engl. Epub. October 7, 2020. doi: 10.1002/ange.202009664.
that a novel digital droplet polymerase chain reaction
(ddPCR) blood test they pioneered could accurately
detect and monitor two mutations of the gene TERT.
The mutations, labeled C228T and C250T, are known
to promote cancer growth and are present in more than
60% of all gliomas and in 80% of all high-grade gliomas,
Blood Test Predicts Which Covid-19 Patients Will
the most aggressive and life-threatening type. The Develop Severe Infection
discovery has the potential to substantially improve the Scientists have developed, for the first time, a score that can accurately
diagnosis and monitoring of gliomas. predict which patients will develop a severe form of covid-19.1 The measure-
Liquid biopsy is a method for detecting cancer by ment, called the Dublin-Boston score, is designed to enable clinicians to
looking for fragments of tumor DNA that circulate in make more informed decisions when identifying patients who may benefit
blood. The technique has been shown to be sensitive from therapies such as steroids and admission to intensive care units.
at detecting the presence of some forms of cancer, but Until this study, led by researchers at RCSI University of Medicine and
brain tumors have until now posed a formidable barrier. Health Sciences in Dublin, Ireland, no covid-19-specific prognostic scores
“Liquid biopsy is particularly challenging in brain were available to guide clinical decision-making. The Dublin-Boston score
tumors because mutant DNA is shed into the blood- can now accurately predict how severe the infection will be on day 7 after
stream at a much lower level than any other types of measuring the patient’s blood for the first 4 days.
tumors,” Balaj says. “By ‘supercharging’ our ddPCR The blood test works by measuring the levels of two molecules: interleukin
assay with novel technical improvements, we showed (IL)-6, which is pro-inflammatory, and IL-10, which is anti-inflammatory. The
for the first time that the most prevalent mutation in levels of both are altered in severe covid-19 patients.
malignant gliomas can be detected in blood, opening Based on the changes in the ratio of these two molecules over time, the
a new landscape for detection and monitoring of the researchers developed a point system where each single-point increase was
tumors.” associated with a 5.6-times increased odds for a more severe outcome. “The
The team’s goal is to expand this blood test to be Dublin-Boston score is easily calculated and can be applied to all hospital-
able to differentiate many types of brain tumors. ized covid-19 patients,” says RCSI Professor of Medicine Gerry McElvaney.
REFERENCE REFERENCE
1. Muralidharan K, Yekula A, Small JL, et al. TERT promoter mutation analysis 1. McElvaney OJ, Hobbs BD, Qiao D, et al. A linear prognostic score based on the ratio of interleukin-6
for blood-based diagnosis and monitoring of gliomas. Clin Cancer Res. Epub. to interleukin-10 predicts outcomes in COVID-19. EBioMedicine.Epub. October 8, 2020. doi: 10.1016/j.
October 13, 2020. doi: 10.1158/1078-0432.CCR-20-3083. ebiom.2020.103026.
10 November 2020 | clpmag.comlabnotes
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The Virus That Took Over the World
The changes wrought by covid-19 may be felt for years to come Nancy Stratton,
COLA.
Interview by Laurie Bonner
I
n the January/February 2020 issue of CLP, because the incidence of the virus in specific technical bulletin with information on the
then-chief editor Steve Halasey inter- areas can change rapidly. FDA’s emergency use authorization (EUA)
viewed Amesh Adalja, MD, FIDSA, senior Our Surveyor team are all COLA employ- process and have given virtual presentations
scholar in the Center for Health Security ees, so we have had the flexibility to resume for the laboratory industry at every oppor-
at Johns Hopkins University, about an surveys using our own discretion and risk tunity. We keep laboratories informed about
emerging viral infection that had only just assessment. When COLA resumed survey- all of the notifications coming from the
appeared on the horizon. The first US case ing, at a limited capacity, in mid-May, we CDC Laboratory Outreach Communication
of what was then called “2019-nCoV” infec- decided to allow our Surveyors to travel System (LOCS) and encourage them to lis-
tion was confirmed on January 20, 2020, and only to laboratories within driving distance ten in to the biweekly CDC conference calls.
as of January 30, 2020, a total of 9,976 cases of their homes, to minimize their risk of We have also recently initiated an online
had been reported in 21 countries. For most exposure. We have also gave our Surveyors chat feature Monday through Friday from 1
Americans at the time, the threat seemed masks, disinfecting wipes, and hand sani- pm to 5 pm EDT on cola.org. This service is
distant, and few were sounding the alarm. tizer and provided them, as well as our open to all laboratory professionals.
Since then, of course, the entire world has laboratories, with precautions that they are We are definitely experiencing a “new
changed. As of October 8, 2020, the count expected to observe during the survey. normal.” I think our industry may have to
of global cases of covid-19 had risen to Although we would like to resume air adapt some long-term new habits, such as
36,281,192, with 1,057,625 deaths; for statis- travel, there are just so many variables and virtual conferences, and find creative ways
tics by country, the United States was num- risks to consider. As a result of the high to network and learn together in a virtual
ber one on both lists, with 7,564,279 cases incidence of the virus in some states, and world. Although we do not expect to con-
and 212,154 deaths. as a result of suspending air travel for an tinue with the virtual survey process after
The effects of the global pandemic have extended period of time, surveys have been the pandemic subsides, it is possible that
reverberated throughout the entire health- delayed, not just for COLA laboratories, but some of the enhanced precautions that we
care industry, in the United States and for other regulatory agencies as well. are taking now will become routine. Perhaps
around the world. For one perspective on In late May, CMS notified the Accrediting some laboratory documentation will be rou-
the impact covid-19 has had on clinical Organizations that, with CMS approval, they tinely reviewed prior to survey. If we can use
labs, CLP interviewed Nancy Stratton, chief could define and implement processes for learnings from the pandemic to make the
executive officer of COLA. remote, or virtual, surveys. This flexibility accreditation process better for everyone,
allows Accrediting Organizations to review we will embrace changes as we look to the
CLP: How has covid-19 affected operations at laboratory processes via other means, until future, whatever it may hold.
COLA? Have your educational offerings and an on-site visit is safe. COLA’s virtual survey
accreditation services changed in any way? process was approved by CMS in July and CLP: What impact has the surging demand for
If so, what changes do you anticipate might has been launched. COLA’s virtual survey covid-19 diagnostic testing had on the busi-
become a permanent “new normal” and why? process includes three components: docu- ness of clinical laboratory management? What
Nancy Stratton: The pandemic has had mentation review; video conference; and additional education/support is COLA offering
a profound effect on the day-to-day busi- brief on-site visit, when it is safe to do so. labs during this time?
ness of accrediting laboratories. During the Of course, we do prefer to perform the Stratton: Many laboratories want to con-
pandemic COLA has been able to provide normal on-site survey where we can, and we tribute to the public health effort by offering
uninterrupted customer support to our are reserving the virtual survey process for covid-19 testing to their communities, but
accredited laboratories, having implement- laboratories located in areas where we have there have been supply chain challenges.
ed our virtual work policy. The most obvi- not been able to travel. This seems to be getting better, although
ous adjustment to normal operations was During the pandemic we have also shifted we have heard that some laboratories have
COLA’s suspension of routine surveys from our educational focus to covid-19. We have acquired equipment to do the testing but
mid-March to mid-May and the subsequent posted regular updates on our customer have been unable to obtain enough testing
intense review of pandemic data to iden- portal and provided links to critical informa- supplies to keep up with the volume.
tify areas of the country where it is safe to tion on the FDA, CMS, and CDC websites. Providing off-site collection sites and/or
perform surveys. This has been a challenge We have provided our laboratories with a temporary testing sites has been a trend, but
12 November 2020 | clpmag.comthese models also come with regulatory constraints, and laborato- have all heard how important it is to get results quickly, to support
ries need information to make sure that these are being operated as effective contact tracing. I do think that laboratories will get to the
required by CLIA and by the various states. point where they can keep up with the demand. A national testing
Laboratories also must be informed about requirements for strategy and a standardized prioritization for testing would be help-
covid-19 testing, including notification of all results, both positive ful toward this goal.
and negative, to the public health agencies. Specific demographic We also need to make sure that covid-19 testing can be performed,
information is required. or at least have samples collected, in schools and businesses that
There have also been EUAs that have been revoked, and the FDA partner with local laboratories to provide rapid and accurate test
has provided guidance on what a lab needs to do if the test system it results in a timeframe that allows mitigation of the spread of the
had been using has had its EUA revoked. So it is essential that labo- infection.
ratory management keep on top of the news, read the LOCS alerts,
and listen in to the CDC meetings. CLP: What advice would you offer to clinical lab managers to better
As mentioned, COLA has stepped up the provision of information prepare for the future as the pandemic continues to unfold?
and guidance to our laboratories, via technical bulletins, online chat, Stratton: By now, every laboratory should be establishing pro-
and regular updates on our customer portal. We have also identified cedures to be implemented during public health crises such as a
dedicated Technical Advisors to field calls and emails specifically on pandemic. This may include emergency staffing procedures, part-
covid-19 testing. We believe that sharing vital information during nerships with regional or national reference laboratories, additional
the pandemic is important for all laboratorians, so we have shared precautions for staff to observe, and test menu prioritizations.
information using social media, blog posts, professional publica- While we don’t recommend stockpiling large amounts of labora-
tions, and virtual presentations. This demonstrates our commit- tory supplies, it might be a good idea to define a minimum amount
ment to the entire industry and the patients that we serve. of safety supplies, such as gloves, gowns, and face shields, to keep on
hand. And make sure you have identified alternate suppliers should
CLP: Initiatives such as RADx are driving innovation, development, and some of these or other supplies become difficult to obtain.
implementation of testing for covid-19. Do you think laboratories will be This pandemic has been tragic in so many ways, but it will be even
able to meet the demand? more tragic if we don’t learn from what we have seen over the past
Stratton: We applaud the National Institute of Health’s RADx months.
initiative for encouraging the rapid development of needed diagnos-
tic testing, especially testing that can be turned around quickly. We Laurie Bonner is chief editor of CLP.
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clpmag.com | November 2020 13Profiles in Leadership
From CEOs to Nobel laureates, women are making their mark in the clinical sciences
By Laurie Bonner
O
n October 7, 2020, news broke that the 2020 Nobel Much of the international news coverage mentioned one fact:
Prize in Chemistry had been awarded to Emmanuelle Charpentier and Doudna are the first team of women to win the
Charpentier, PhD, and Jennifer Doudna, PhD, “for the Nobel Prize in Chemistry together. Prior to this year, only five
development of a method of genome editing.” Charpentier, of women had ever received this award—Ada E. Yonath (2009) and
the Max Planck Unit for the Science of Pathogens in Berlin, and Irene Joliot-Curie (1935) shared the prize with male partners, and
Doudna, of the University of California, Berkeley, developed the Frances H. Arnold (2018), Dorothy Crowfoot Hodgkin (1964), and
CRISPR/Cas9 genetic scissors—“one of gene technology’s sharp- Marie Curie (1911) earned the prize solo.
est tools,” according to the statement from the Royal Swedish Charpentier and Doudna (pictured above receiving the 2017
Academy of Sciences. “Using these, researchers can change the Japan Prize) are not the only women building successful careers
DNA of animals, plants, and microorganisms with extremely high in the clinical lab sciences. CLP reached out to Doudna—and six
precision. This technology has had a revolutionary impact on the other women whose leadership and innovations are reshaping
life sciences, is contributing to new cancer therapies, and may the field—to ask how gender matters and about the prospects for
make the dream of curing inherited diseases come true.” women in clinical lab sciences. Here’s what they said.
14 November 2020 | clpmag.comJennifer Doudna, ing different perspectives to take a seat at spinal fluid, environmental samples, etc.)
PhD the bench. for all possible microorganisms, advanc-
Li Ka Shing Chancellor’s ing positive clinical outcomes for patients
Chair/Professor CLP: What advice do you offer to young across the country.
University of California, people aspiring to a career path like
Berkeley yours? CLP: Does gender matter? What does
Investigator Doudna: You don’t have to act or look a female leadership bring to the clinical
Howard Hughes Medical Institute certain way to be a scientist; you just have lab sciences?
With collaborator Emmanuelle Charpen- to pursue what interests you and know Icenhour: As the chief executive officer
tier, PhD, Doudna developed CRISPR/Cas9, that you belong there. Surround yourself of a fast-growing biotechnology compa-
genome-editing technology that has redi- with people who support your dreams and ny within a male-dominated industry, I
rected the course of healthcare and agri- share your curiosity. I wouldn’t be sitting know firsthand how gender can factor
cultural research. Doudna is also a leader here today offering this advice if I hadn’t into the equation. As the first woman
in public discussion of the ethical and other
had a strong community that helped me Board Chairman in the history of the
implications of genome editing for human
along the way. Virginia Biotechnology Association, I
biology and societies, and she advocates for
thoughtful approaches to the development devoted countless hours of my time and
of policies around the use of CRISPR-Cas9. Crystal Icenhour, energy to setting an example for both men
In 2017, Doudna co-founded Mammoth PhD and women in the industry. I tend to see
Biosciences, a business focused on improv- Chief Executive Officer beyond gender by focusing on people as
ing access to biosensing tests. She earned and Co-Founder individuals and empowering both men
a PhD in biological chemistry and molecu- Aperiomics, Sterling, Va and women to rise up and thrive.
lar pharmacology from Harvard Medical With more than 25 I also know how critically important
School. years of clinical research female leadership can be for clinical lab
expertise, Crystal R. Icenhour, PhD, founded sciences. Raised in rural West Texas,
CLP: Can you describe what it means to Aperiomics with the mission to harness many of the closest women in my life fre-
you to have your work recognized with a next-generation DNA sequencing and arti- quently failed to receive sufficient medi-
Nobel Prize? ficial intelligence to identify every known cal care. My grandmother suffered from
Doudna: I’m really proud. I’m proud pathogen—bacteria, viruses, fungi, and par- undiagnosed chronic pain that doctors
to represent a public university like UC asites—using a single test. Icenhour holds regularly dismissed—an issue that far too
Berkeley that supports great science and two patents, has authored and co-authored many women have experienced. That is
education, one that serves the public good numerous research articles and theses, and why I remain steadfast in my commit-
and welcomes people of all backgrounds. has been a prolific speaker at scientific ment to improve the way diseases are
It’s also a great moment for basic science. conferences. As a world-renowned expert understood and tested—not only to raise
We didn’t start studying CRISPR with the in microbiology, she has served on review the standard of care that the women in
idea that it would turn into a tool with panels for the National Science Foundation, my family were not afforded, but also
so many applications. I was driven by sci- the Environmental Protection Agency, and to ensure patients experiencing chronic
entific curiosity, and I’m so fortunate to National Institutes of Health Small Business pain are heard, diagnosed properly, and
have been supported to follow that curios- Innovation Research Program. effectively cared for.
ity and to have built a community of col-
leagues along the way. CLP: Tell us about your proudest career CLP: What advice do you offer to young
achievement. people aspiring to a career path like
CLP: Does gender matter? What does Icenhour: My proudest career achieve- yours?
female leadership bring to the clinical ment has been leading Aperiomics’ Icenhour: I like to tell young people they
lab sciences? effort to disrupt and advance the way don’t have to choose between a family and
Doudna: Gender absolutely matters. I’m our healthcare system approaches patho- a career in science. I believe family sup-
proud to be a female scientist. There are gen identification. By integrating inno- port and encouragement allow for one to
people of all types who are great scien- vative technology, entrepreneurial savvy, have both. I am the CEO and co-founder
tists—or they could be if given the oppor- and industry expertise to improve clini- of my own business, an active advocate
tunity. Growing up, I couldn’t possibly have cal outcomes for patients, I have helped in the biotechnology industry, and also
imagined a future that looks like the life I spearhead the creation of Aperiomics’ raising four kids. When you have a nurs-
lead now, because I had never seen it with cutting edge technology to identify every ing infant and need to travel for business,
my own eyes. I hope this award shows pathogen known to modern science. attend a conference, or meet with an
young women that a career in lab science Using Deep Shotgun Metagenomic DNA investor, it seems to me the only solution
is not only a real possibility, but that the sequencing, advanced bioinformatics, is: You take the baby with you. There’s
community wants them and needs them. and artificial intelligence, our team is certainly no better ice breaker! There is
Scientific advances take creativity and new able to test the widest range of clinical even a photo of me (discreetly!) nursing
ways of thinking, and we get that by invit- sample types (skin, urine, fecal, blood, my daughter Sabrina at a meeting with
clpmag.com | November 2020 15the Governor of Virginia. I encourage oth- people aspiring to a career path like laboratories and their important work to
ers to not let societal pressures prevent yours? serve clinicians’ needs and, ultimately,
you from doing what is best for you and Li: No doubt a career in healthcare indus- the patients they serve are so needed.
your family. try is very rewarding. Know your passion The diagnostic industry has a spotlight to
and what you are good at, and if you bring products to market in record time
Lily Li, MD, PhD can combine these two, hard work often to provide the best solutions to clinicians
Medical Safety Officer becomes enjoyable. Do not stop learning in the fight against covid-19.
Ortho Clinical and always try to expand your horizons;
Diagnostics, Raritan, NJ you may be amazed to find new tal- CLP: Does gender matter? What does
Lily Li, MD, PhD, is ents! Treasure teamwork, and remember female leadership bring to the clinical
the medical safety offi- that people are always more important lab sciences?
cer at Ortho Clinical than projects. Regardless of your level or Orland: My mission and vision to pur-
Diagnostics responsible for evaluating role in your organization, you can always sue a career in clinical lab sciences stem
potential medical risks and guiding risk enable, encourage, and motivate others, from my mother passing away from breast
mitigation of all marketed products. She and together you can achieve something cancer when I was 11. From that time, I
also serves as a director at medical and bigger and better than you could have always wanted to play a role in the medi-
scientific affairs providing evidence-based ever dreamed. cal arena. Through my current role, I feel
support to Ortho’s current and future I’m bringing about my own life’s purpose
products. Li obtained her medical degree Kathleen Orland to make a difference.
from Peking University, China, her PhD Senior Vice President Because my mother passed away when
in Immunology from the University of and General Manager I was so young, my father raised my two
Alberta, Canada, and an MBA from Temple Beckman Coulter, younger brothers and me. I have often
University. Lily is the author of more than Brea, Calif found myself to be the only female in the
40 scientific articles and has filed 17 patent As senior vice presi- room. I rarely think about gender; I simply
applications. dent and general man- do my best every day to support our team
ager for Beckman Coulter’s Clinical to meet our mutual objectives.
CLP: Tell us about your proudest career Chemistry Immunoassay (CCIA) business When you have female leadership in
achievement. unit, Kathleen Orland leads product strat- clinical lab sciences, you bring a differ-
Li: All my career successes are attached egy and new product development pro- ent thought process to the table. Men
to great teamwork, and I have been grams across eight global sites. Since join- and women may think of things differ-
fortunate to be part of several high- ing Beckman Coulter as a senior product ently, and having a woman in clinical lab
performance teams. Most recently, in manager for Immunoassay in 2005, she leadership brings a diversity of thought
response to the urgent needs for sero- has served in multiple positions including when a man might not share the same
logical tests for covid-19, Ortho formed vice president of CCIA product manage- perspective.
an amazing team with experienced and ment. Orland has a bachelor’s degree in The necessity for diversity is not only
fully dedicated people and developed two microbiology from University of Illinois at gender-related but cultural as well.
high-quality SARS-CoV-2 antibody tests Urbana-Champaign, and she earned her Diversity of thought brings about dif-
at record speed. I am very proud to be Medical Technologist MT(ASCP) credential ferent perspectives and creativity.
part of this team supporting the develop- from NorthShore University HealthSystem. Ultimately, when diversity of thought is
ment of medical contents and providing present across your team, you achieve
internal and external trainings on the CLP: Tell us about your proudest career better results when unique perspectives
clinical utilities of the assays. achievement. come together holistically to challenge
Orland: I have had many career achieve- the status quo.
CLP: Does gender matter? What does ments that I am proud of since start-
female leadership bring to the clinical ing my career as a medical technologist, CLP: What advice do you offer to young
lab sciences? working in the hospital laboratory, and people aspiring to a career path like
Li: No, in clinical lab sciences, gender later transitioning into marketing and yours?
does not matter and there is nothing product management. In my current role Orland: Believe you can achieve any-
female scientists and leaders cannot do. I at Beckman Coulter, my proudest career thing. People are very generous with their
believe female leaders often demonstrate achievement has been leading the busi- time to mentor or coach; if you have ques-
ownership, accountability, and dedica- ness through the successful launch of tions, or want to reach different career
tion, and we pay attention to details and important assays, namely receiving emer- opportunities, don’t feel limited or intimi-
are willing to work behind-the-scenes, all gency use authorization for our Access dated. Reach out, talk to people. See if
of which are crucial to the type of work SARS-CoV-2 IgG and IgM assays as well you can job shadow, learn, and explore.
we do. as for IL-6. You can do anything you set your mind
There has certainly never been a point to, so set your sights high, have a vision
CLP: What advice do you offer to young in time like the present, where the clinical for your future, and pursue it. Never be
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T 888.UTAK.LAB F 661 294 9272 welovecontrol@utak.com UTAK.COMlimited in your own beliefs about what The idea was born in 2010, but big observe about what works and what
you’re capable of. change doesn’t happen overnight. I had to doesn’t. Identify people you admire and
Also, continually explore, aspire, and convince many who were concerned that learn from them even if via a TED talk
challenge yourself. Listen and thank customers would not adapt to the new or by reading a few pages out of a book.
people when they provide feedback to learning method. In 2014, Sysmex deliv- I would have never pictured my career
you—incorporate their suggestions into ered its first VILT class, enabling every being so diverse, broad, and rewarding.
your professional progression. Own your user in the lab to receive the same training I couldn’t have done it without leader-
career development and drive it—nobody experience from subject matter experts. ship who believed in me (more than I did
can do this, but you. In 2018, we opened the doors to our myself at times) and a strong commit-
Some women will shrink when it comes Center for Learning, which boasts more ted team. Overall, it’s important to make
to taking leadership roles—instead, you than 17,000 customers trained across the time in your schedule to stretch your
need to be willing to take your space. You United States, Canada, and Latin America horizons.
have an equal seat at the table, just like (a four-fold training increase), a 92% cus-
any other person, male or female. You tomer satisfaction rate, and excellence in Tamara Ranalli,
deserve that spot, so own it and never shy technology and learning awards. PhD
away from achieving your goals. Vice President, Molec-
CLP: Does gender matter? What does ular Business Unit
Stephanie Post female leadership bring to the clinical Quidel, San Diego
Senior Director, lab sciences? Tamara Ranalli, PhD,
Marketing Post: The underrepresentation of women was named senior vice
Communications, in science, or any field, slows the progress president of Quidel’s Molecular Business
Center for Learning & of discovery and innovation by exclud- Unit in August 2020. Previously, she was
Program Management ing people who have the ability to make the director of business development at
Sysmex America, significant contributions. Clinical labora- BioHelix Corporation, where she was
Lincolnshire, Ill tory scientists are smart, competent, and instrumental in both the development of
In her current role at Sysmex America, strategic. Female leadership in clinical the novel isothermal technology used in
Stephanie Post is known as a champion lab science roles must use this founda- the AmpliVue and Solana platforms as well
of change with “out-of-the-box” thinking to tion to create a culture to empower their as the establishment of the collaboration
lead a high-performing department focused teams’—both male and female—capabili- between BioHelix and Quidel that led to
on customer training, sales training, techni- ties, aptitudes, and positive attitudes. We the eventual acquisition of BioHelix in 2013.
cal training, instructional design, studio must put leaders and their staff in posi- Ranalli holds a BA in biology from Cornell
production, project management, and mar- tions that are a “jacket size too big” to University and a PhD in biochemistry from
keting communications. Post is a board- inspire continual development and curi- University of Rochester School of Medicine.
certified clinical laboratory scientist and osity to break paradigms. We must pair
holds certifications in the training field as leaders with different skillsets, genders, CLP: Tell us about your proudest
a training director, instructor/facilitator, and experiences to complement each career achievement.
sales trainer, and performance consultant. other, learn from each other, and chal- Ranalli: I think one of the career
lenge each other. Innovations like VILT achievements that I’ve been most proud
CLP: Tell us about your proudest career for Sysmex have come from this type of was taking over the VP of Marketing
achievement. of leadership and opportunity to stretch position at Quidel. I’m a biochemist by
Post: Working as a visionary change agent, individuals beyond their wildest dreams. training, and it was incredibly exciting
I shifted Sysmex America away from its and rewarding for me to be able to ful-
traditional in-house train-the-trainer CLP: What advice do you offer to young fill a role in the organization that is not
model for instrument training to respond people aspiring to a career path like traditionally led by a PhD scientist. My
to changing needs of Sysmex’s growing yours? passion for our products and for our com-
customer and employee base. The suc- Post: Prioritize your own learning, recog- pany, and my love of making sure we are
cess of our Virtual Instructor-Led Training nizing all the ways to gain new knowledge represented well out in the world, I think
(VILT), available for all of our instruments and experience. Find a mentor who is a comes through, and it’s made me incred-
today, initiated and drove a multimillion- leader, and don’t be afraid to say “Yes” to ibly proud that Quidel would grant me the
dollar project to build a state-of-the-art new experiences. I started with a passion opportunity to take on that role and work
Center for Learning. Housing seven pro- for laboratory medicine and a degree in in that area.
duction studios to live-stream training clinical laboratory science. Using those
over the internet, we hired camera people, foundational skills, I pushed boundaries CLP: Does gender matter?
directors, and producers—not the norm into sales, marketing, training and devel- Ranalli: Definitely. When I was in gradu-
for a laboratory medical device compa- opment, and studio production leader- ate school in my 20s, my class was bal-
ny—and our instructors learned how to be ship. anced between men and women. However,
on-camera talent. Write down what you see, know, and in postgraduate school, the numbers
18 November 2020 | clpmag.comYou can also read
