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Prospera™ Precision— from the Experts of Cell-Free DNA Testing

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Prospera™ Precision— from the Experts of Cell-Free DNA Testing 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 rejection2 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 rejection2,4,5 Up to 5x less variability than first-generation donor-derived cell-free DNA technology1,3 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 TRANSPLANT PATIENT CARE TOOLKIT 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: Minimal donor-derived cell-free yet are not specific may indicate patients complications, technology that is C T A DNA (dd-cfDNA) is released in a G A T or sensitive enough that are at higher risk interpretation highly accurate in 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 Establish a personalized dd-cfDNA baseline to 0.6% determine a normal-state dd-cfDNA of the patient’s new kidney 4 Track dd-cfDNA 0.5% levels over time 0.4% Date of blood draw T1 T2 T3 T4 T5 T6 T7 Oct 2, 2019 Nov 4, 2019 Dec 5, 2019 Jan 7, 2020 Mar 5, 2020 Jun 4, 2020 Sep 7, 2020 Now—catch ALL rejection types in a single blood draw Prospera’s unique ability to identify both ABMR and TCMR gives Lower risk of missing active rejection a comprehensive view of your patient’s rejection status. With 95% negative predictive value (NPV), Prospera misses nearly HIGHLY SENSITIVE TO IDENTIFY ALL TYPES OF REJECTIONS 1 3 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 NPV: 86% 2 1.0 Serum creatinine 5% missed dd-cfDNA Level (%) ~3x NPV: 95% fewer rejections 0.1 Unparalleled missed Prospera2 ABMR ABMR ABMR bABMR TCMR (3) bTCMR TCMR TCMR (8) (13) (12) (2) precision. Prospera can assist in the decision to rule out active rejection before considering ABMR/TCMR the necessity of a biopsy.2 Assessing for ABMR and cell-mediated rejection enables clinicians to have a Optimized by more comprehensive understanding for earlier, timely coordination of clinical management and a chance to save a patient’s kidney. 0.66% More sensitive and specific than standard Range of first-generation dd-cfDNA Prospera. Range of Prospera screening tools Actual 0.61% In a published clinical validation, Prospera demonstrated better .6 Highly accurate in both surveillance0.6% 0.59% performance in correctly classifying patients with active rejection— 2 including TCMR.2 Serum creatinine may incorrectly classify and for-cause settings up to 1 out of 2 patients experiencing active rejection as normal.2 0.54% 2 4 Prospera is the first cfDNA assay to publish performance in surveillance situations. OF 100 ACTIVE REJECTION CASES, THE NUMBER OF PATIENTS WHO WOULD BE MISSED SIMILAR% of dd-cfDNA PERFORMANCE IN STABLE AND THOSE WITH CLINICAL SIGNS OF REJECTION Using a 1% dd-cfDNA threshold Active rejection Sensitivity Negative predictive value* Serum creatinine2 Actual Clinical AR 0.4% 86% 93.8% 48/100 .4 Sensitivity: 52% Subclinical AR 92% 98.3%** Prospera2 *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 PATIENT: Sherry Finley 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 PATIENT 0.5% LIAISON COORDINATOR COORDINATOR 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 even more confident results Learn from our clinical Offer to all kidney Easily order via paper, Monitor orders, access Track dd-cfDNA 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 exible 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.
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