prospera transplant assessment test · 2019-09-03 · prospera : transplant assessment test broad,...

Simpler and less invasive than biopsy; no donor genotyping required Suitable for most renal allograft patients across ethnicities More sensitive and specific for clinical and subclinical active rejection than serum creatinine 2 Up to 5x more reduction in variability than that of a competitive dd-cfDNA assay 1,3 Analytically & clinically validated to be: 266 9.2% 4.5% NO Prospera 2 Existing Commercial Assay 3 Prospera : Transplant assessment test Broad, highly accurate assessment of active rejection DIVERSE COHORT KEY ADVANTAGES 107 0.74 Prospera 1 Existing Commercial Assay 4 More SNPs targeted and analyzed 2 Precision within run 5x better 2 Coefficient of Variation Precision across runs 2.3x better 2 Coefficient of Variation Only assay with evaluated performance in related and unrelated donors T-cell mediated rejection IA/IB/IIB Antibody-mediated rejection C4d-positive antibody-mediated rejection Acute rejection Chronic active rejection Mixed rejection • • • • • • • • • • Largest published renal transplant dd-cfDNA validation study 1 Highest reported overall accuracy 1 AUC First, only test to identify subclinical rejection 1 Sensitivity Highest reported performance to assess T-cell mediated rejection 1 Sensitivity Broad distribution of rejection types 2 Hispanic / Latino (n=50) Caucasian (n=74) African American (n=31) Asian (n=31) Variety of ethnic and racial demographics 2 CAP accredited, ISO 13485, and CLIA certified. © 2019 Natera, Inc. All Rights Reserved. PRO_ESOT_BoothPoster_20190903_NAT-8019995 1 Sigdel, et al. J Clin Med. 2019;8(1):19. 2 Altuğ, et al. Transplantation, 2019 3 Grskovic, et al. J Mol Diagn. 2016;18(6):890-902. 4 Bloom RD, et al. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232. PERFORMANCE COMPARISON Of 100 active rejection cases, the number of patients who would be missed, and told they are normal* *Using a 1% dd-cfDNA threshold NA 27% ™ ANALYTICAL VALIDATION CLINICAL VALIDATION 217 0.87 92% 100% ~ 13,000 1.85% 1.9% YES Prospera 1 First-generation dd-cfDNA 4 Sensitivity Sensitivity 89% 59% 11 / 100 41 / 100

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Page 1: Prospera Transplant assessment test · 2019-09-03 · Prospera : Transplant assessment test Broad, highly accurate assessment of active rejection DIVERSE COHORT KEY ADVANTAGES 107

Simpler and less invasive than biopsy; no donor genotyping required

Suitable for most renal allograft patients across ethnicities

More sensitive and speci�c for clinical and subclinical active rejection than serum creatinine2

Up to 5x more reduction in variability than that of a competitive dd-cfDNA assay1,3

Analytically & clinically validated to be:

266

9.2%

4.5%

Prospera2 ExistingCommercial Assay3

Prospera : Transplant assessment testBroad, highly accurate assessment of active rejection

DIVERSE COHORT

KEY ADVANTAGES

107

0.74

Prospera1 ExistingCommercial Assay4

More SNPs targeted and analyzed2

Precision within run 5x better2

Coef�cient of Variation

Precision across runs 2.3x better2

Coef�cient of Variation

Only assay with evaluatedperformance in related and unrelated donors

T-cell mediated rejection IA/IB/IIBAntibody-mediated rejectionC4d-positive antibody-mediated rejectionAcute rejectionChronic active rejectionMixed rejection

••••••

•

Largest published renal transplant dd-cfDNA validation study1

Highest reported overall accuracy1

AUC

First, only test to identify subclinical rejection1

Sensitivity

Highest reported performance to assess T-cell mediated rejection1

Sensitivity

Broad distribution of rejection types2

Hispanic / Latino (n=50)Caucasian (n=74)African American (n=31)Asian (n=31)

Variety of ethnic and racial demographics2

1 Sigdel, et al. J Clin Med. 2019;8(1):19.2 Altuğ, et al. Transplantation, 20193 Grskovic, et al. J Mol Diagn. 2016;18(6):890-902.4 Bloom RD, et al. J Am Soc Nephrol. 2017 Jul;28(7):2221-2232.

PERFORMANCE COMPARISON

Of 100 active rejection cases, the number of patients who would be missed, and told they are normal*

*Using a 1% dd-cfDNA threshold

27%

™

ANALYTICAL VALIDATION CLINICAL VALIDATION

217

0.87

92%

100%

~ 13,000

1.85%