Prospera precision- from the experts of cell-free DNA testing
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Prospera™ precision— from the experts of cell-free DNA testing New! From Natera Covered by Medicare
Introducing Prospera
Prospera is powered by highly optimized,
proprietary cell-free DNA (cfDNA) technology.
As part of your tool kit, Prospera assesses
all types of kidney transplant rejection 2
with great precision.1,3
Covered by Medicare for all
kidney transplant recipients
Simpler and less invasive
than biopsy
More sensitive and specific than
current assessment tools across
all types of rejection 2,4,5
Up to 5x less variability than
first-generation donor-derived
cell-free DNA technology 1,3
The need for something better. Experts in cell-free DNA.
For transplant clinicians treating, monitoring and managing patients across the entire
transplant continuum— Optimized for transplantation.
To improve the management of organ transplantation, cancer, and reproductive health, Natera is
the goal is earlier, accurate detection of rejection that harnessing the power of cfDNA from a single blood sample and a methodology that uses single-nucleotide
enables treatment to promote longer graft life. polymorphisms (SNPs) for non-invasive testing.
Current tools to monitor rejection are limited as they risk detecting rejection late or not at all, Optimized
Organ Transplantation platform
which often leads to chronic active antibody-mediated rejection (ABMR) and eventual graft
Highest performing dd-cfDNA test
failure. The lack of an effective tool to identify clinical and subclinical antibody-mediated and
T cell-mediated rejection (TCMR) presents a critical challenge to the clinician. Applied
Oncology experience
First custom-built circulating-tumor DNA test
Built
Women’s Health foundation
Pioneered SNP-based technology to a broad prenatal-testing product suite
T R A N S P L A N T PAT I E N T C A R E T O O L K I T An established methodology using a validated biomarker
Cell-free DNA (cfDNA) technology is an established methodology in prenatal, oncology and
transplantation applications.3,5,7-12 Further, cfDNA is a proven biomarker in kidney and heart
transplantation 1-5,7,13-17 for identifying active rejection.
Serum Donor-specific Prospera
creatinine antibodies Biopsy transplant
tests (DSA) assessment Applying proven cell-free DNA experience to assess kidney injury
From a single blood draw, Prospera measures the amount of donor DNA from the transplanted kidney
in the patient’s blood. This will help you and your care team assess all types of rejection more precisely
than available standard assessment tools.
HOW PROSPERA WORKS
Recipient Blood Sample Precise Identification Interpretation
Current baseline Often late indicator Infrequently used Non-invasive, Donor
screening standard, of active rejection, due to cost, potential optimized cfDNA NO active rejection:
yet are not specific may indicate patients complications, technology that is C T A
Minimal donor-derived cell-free
DNA (dd-cfDNA) is released in a
or sensitive enough that are at higher risk interpretation highly accurate in G A T
stable patient’s blood.
for allograft rejection2 for rejection6 challenges and assessing all types
patient discomfort of active rejection SNP difference OR
Active rejection:
T T A Upon cell injury, more dd-cfDNA
A A T
is released from the donor
kidney.
Recipient
Mix of donor and recipient >13,000 single-nucleotide polymorphisms Prospera reports the percentage of dd-cfDNA
cell-free DNA (cfDNA) (SNPs) and advanced bioinformatics are used in a transplant recipient’s blood
to differentiate recipient and donor cfDNA
PERSONALIZED ASSESSMENT
Patient Test Summary
fDNA
Establish a personalized
dd-cfDNA baseline to
Now—catch ALL rejection types in a single blood draw
1 3
Prospera’s unique ability to identify both ABMR and TCMR gives
a comprehensive view of your patient’s rejection status.
Lower risk of missing active rejection
With 95% negative predictive value (NPV), Prospera misses nearly
HIGHLY SENSITIVE TO IDENTIFY ALL TYPES OF REJECTIONS three times fewer rejections than serum creatinine.2
COMPARISON OF NPV FROM PUBLISHED VALIDATION STUDIES
Based upon 25% prevalence of active rejection 2
10.0 14% missed
dd-cfDNA Level (%)
NPV: 86%
1.0 Serum creatinine2
~3x
5% missed
0.1 Unparalleled NPV: 95%
Prospera 2
fewer rejections
missed
precision.
ABMR ABMR ABMR bABMR TCMR
(3) bTCMR TCMR TCMR (8)
(13) (12) (2)
Prospera can assist in the decision to rule out active rejection before considering
Optimized by
ABMR/TCMR the necessity of a biopsy.2
Assessing for ABMR and cell-mediated rejection enables clinicians to have a
more comprehensive understanding for earlier, timely coordination of clinical
Prospera.
management and a chance to save a patient’s kidney.
0.66%
More sensitive and specific than standard
2
Range of first-generation dd-cfDNA
Range of Prospera
screening tools
4
Actual 0.61% In a published clinical validation, Prospera demonstrated better
.6
Highly accurate in both surveillance 0.6% 0.59% performance in correctly classifying patients with active rejection—
including TCMR.2 Serum creatinine may incorrectly classify
and for-cause settings
% of dd-cfDNA
up to 1 out of 2 patients experiencing active rejection as normal.2
0.54%
Prospera is the first cfDNA assay to publish performance in surveillance situations.2
OF 100 ACTIVE REJECTION CASES, THE NUMBER OF PATIENTS WHO WOULD BE MISSED
SIMILAR PERFORMANCE IN STABLE AND THOSE WITH CLINICAL SIGNS OF REJECTION Using a 1% dd-cfDNA threshold
Active rejection Sensitivity Negative predictive value* Serum creatinine 2
Clinical AR 0.4%
Actual
86% 93.8% 48/100
.4 Sensitivity: 52%
Subclinical AR 92% 98.3%** Prospera 2
*Assuming 25% AR Prevalence (higher risk population) **Assuming 10% AR Prevalence (low risk population) 11/100
Date of T1 T2 Sensitivity: 89%
blood draw Oct 2, 2019 Nov 4, 2019
Using Prospera in a surveillance setting can enable clinicians to effectively manage transplant Prospera provides confident results to reassure you in your clinical care decisions when managing
patients with unsuspected, subclinical rejection as a way to increase the longevity of their kidney.2 your transplant patients.
Patients first. Partners always.
Pledging ongoing support and resources for seamless integration into your
clinical workflow.
Natera partners with you to enable your team for:
• Easy ordering
• Convenient blood draw options
• Transparent tracking
• Results at your fingertips
• Dedicated support at every step
Sherry Finley
PATIENT:
DOB:7/8/1987
OCCUPATION: Teacher
How we enable you: ProsperaLink Program
cfDNA Results: 0.28%
Your concierge team of Natera clinical experts to help you and your transplant
0.8% care team at every step of the way.
0.7%
0.6% MEDICAL SCIENCE NURSE PAT I E N T
0.5% LIAISON C O O R D I N AT O R C O O R D I N AT O R
0.4%
0.3%
Time post-transplant
• Monthly case reviews • Kit fulfillment • Scheduling of patient
blood draws
• ProActive registry study • Portal set up and
troubleshooting • Billing and logistical
• Educational programs
support for patients
• Call Out Program
(if result >1%)
• Shipping logistics
Natera welcomes all insurances. Prospera is covered by Medicare for assessing potential kidney transplant
rejection. The goal of Natera’s billing department is to make the process transparent and easy for our patients.
In the rare event your patient has financial responsibility for Prospera, Natera offers flexible financial assistance
programs and will work closely with your patient to ensure there is no hardship on them or their family.
In all cases, the Natera team is here to help you, your staff, and your patients with any billing or reimbursement
questions and needs at +1 650.273.4468.
Simplified for you, along every step.
Protect every patient’s life with best-in-class care to live
long and prosper
Optimized surveillance for
Education Access Ordering Results Next Steps
Learn from our clinical Offer to all kidney Easily order via paper, Monitor orders, access Track dd-cfDNA
even more confident results
team through transplant patients, online portal or EMR actionable report levels over time after Precise cell-free DNA testing from the experts
informational sessions, including those and flexible blood draw supplements and establishing a
on-demand videos, covered by Medicare options including share with the broader personalized baseline to
webinars and online mobile phlebotomy transplant care team determine “normal state”
learning materials of a patient’s new kidney
References
1 Altug Y, Liang N, Ram R, et al. Analytical validation of a single-nucleotide polymorphism-based donor-derived cell-free DNA assay for detecting rejection in kidney transplant patients.
Transplantation, 2019
2 Sigdel TK, Archila FA, Constantin T, et al. Optimizing detection of kidney transplant injury by assessment of donor-derived cell-free DNA via massively multiplex PCR. J Clin Med. 2019;8(1):19.
3 Grskovic M, Hiller DJ, Eubank LA, et al. Validation of a clinical-grade assay to measure donor-derived cell-free DNA in solid organ transplant recipients. J Mol Diagn. 2016;18(6):890-902.
4 Bromberg JS, Brennan DC, Poggio E, et al. Biological variation of donor-derived cell-free DNA in renal transplant recipients: clinical implications. J Appl Lab Med. 2017;2(3):309-321.
5 Bloom RD, Bromberg JS, Poggio ED, et al. Cell-free DNA and active rejection in kidney allografts. J Am Soc Nephrol. 2017;28(7):2221-2232. doi: 10.1681/ASN.2016091034.
6 Cooper J, Gralla J, Cagle L. Inferior Kidney Allograft outcomes in Patients With De Novo Donor-Specific Antibodies Are Due to Acute Rejection Episodes. Transplantation 2001;91: 1103-1109
7 Snyder, et al. Universal noninvasive detection of solid organ transplant rejection. Proc. Natl. Acad. Sci. USA 2011, 108, 6229 - 6234
8 Palomaki, et al. DNA sequencing of maternal plasma to detect Down syndrome: an international clinical validation study. Genet Med. 2011 Nov;13(11):913-20
9 Sparks, et al. Noninvasive prenatal detection and selective analysis of cell-free DNA obtained from maternal blood: evaluation for trisomy 21 and trisomy 18. Am J Obstet Gynecol.
2012, 206, P319.E1 - 319.E9
10 Newman, et al. An ultrasensitive method for quantitating circulating tumor DNA with …. Nat Med 2014, 2014 May;20(5):548-54
11 Pergament, et al. Single-nucleotide polymorphism-based noninvasive prenatal screening in a high-risk and low-risk cohort. Obstet. Gynecol. 2014, 124 Pt 1, 210 - 218
12 Abbosh, et al. Phylogenetic ctDNA analysis depict early-stage lung cancer evolution. Nature 2017, 545, 446 - 451
13 Lo, et al. Biomarkers for kidney transplant rejection. Nat. Rev. Nephrol. 2014, 10, 215 - 225
14 Beck, et al. Digital droplet PCR for rapid quantification of donor DNA in the circulation of transplant recipients as a potential universal biomarker of graft injury. Clin. Chem. 2013, 59, 1732-1741
15 De Vlaminck, et al. Circulating cell-free DNA enables noninvasive diagnosis of heart transplant rejection. Sci. Transl. Med. 2014, 6, 241ra77
16 Hidestrand, et al. Highly sensitive noninvasive cardiac transplant rejection monitoring using targeted quantification of donor-specific cell-free deoxyribonucleic acid. J Am Coll Cardiol.
2014;63(12):1224–1226. doi:10.1016/j.jacc.2013.09.029
17 Huang, et al. Early clinical experience using donor‐derived cell‐free DNA to detect rejection in kidney transplant recipients. Transplantation. 2019, doi: 10.1111/ajt.15289.Only from Natera
Our mission is to improve disease management for patients worldwide. We have been
exploring and evolving our expertise in cell-free DNA (cfDNA) across women’s health,
oncology and organ transplant care. We founded our company to use the most
innovative technology for earlier detection of genetic conditions in pregnancies. In the
years since, we have helped nearly two million families on their path to parenthood
with solutions that tell them about the genetic health of their babies.
Built on Natera’s pioneering technology, our first circulating tumor DNA (ctDNA) test is
custom-built and personalized for each cancer patient. Now, we have refined our
technology to assess tiny amounts of donor DNA in the blood of kidney transplant
patients. And that’s just the start.
With all the rapid advances taking place in cfDNA at Natera, there is one constant:
our unwavering commitment to patients.
2M + 100 + 90 CAP CLIA
cfDNA tests clinicians, PhD’s, countries accredited certified
performed and scientists worldwide
201 Industrial Road, Suite 410, San Carlos, CA 94070 | Main +1 650.249.9090 | Fax +1 650.730.2272 | natera.com
The test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has
not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA has generally not enforced the premarket review and other FDA
legal requirements for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.
CAP accredited, ISO 13485, and CLIA certified. © 2020 Natera, Inc. All Rights Reserved. PRO_BR_CommNeph_20200416_NAT-8020141
Learn more about Prospera:
Call us +1 650.273.4468
Visit us natera.com/prosperaYou can also read
