Validation

Vectra® DA was validated to assess RA disease activity through a rigorous development process

A multistep development process involving over 1,900 serum samples from more than 1,700 RA patients1
Pg10 (2)flow chart

  • The 12 protein biomarkers were selected from a pool of 396 candidate biomarkers2
  • Validated against the DAS28-CRP in both seropositive (AUROC = 0.77; P<0.001) and seronegative patients (AUROC = 0.70; P<0.001)2
  • Significantly correlated with change in disease activity based on DAS28-CRP and DAS28-ESR2,3
  • Precise and reproducible — 28 samples were each assayed 10 times over multiple days with multiple operators (median coefficient of variation = 1.6%)4

 

When to use Vectra DA

 
 

Crescendo Bioscience Laboratory Certifications

Federal CLIA Certificate

The Centers for Medicare & Medicaid Services (CMS) regulate all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing.

CAP Laboratory Accreditation Program

The commission on Laboratory Accreditation of the College of American Pathologists examined Crescendo Bioscience’s laboratory records and quality control procedures for the preceding 2 years. In addition, staff qualifications, laboratory equipment, and the facility’s safety program and record, as well as the overall lab management were examined.

New York State Clinical Laboratory Permit

The Wadsworth Center at the New York Department of Health through its Clinical Laboratory Evaluation Program (CLEP) issued a laboratory permit to Crescendo Bioscience to provide services to physicians/patients in New York. The excellence of the CLEP program has been acknowledged by CMS through their granting of exempt status from the federal CLIA for laboratories located in and holding NYS clinical laboratory permits.

CMS coverage policy issued by Palmetto GBA for Vectra DA

Palmetto GBA posted a favorable coverage article for Vectra DA on May 10, 2013 under the Medicare Part B program, which also drives coverage policies for the large Medicare Advantage Plans.

 


References:

* 1. Centola M, Cavet G, Shen Y, et al. Development of a multi-biomarker disease activity test for rheumatoid arthritis. PLOS ONE. 2013;8(4):e60635.

* 2. Curtis JR, van der Helm-van Mil AH, Knevel R, et al. Validation of a novel multibiomarker test to assess rheumatoid arthritis disease activity. Arthritis Care Res. 2012;64(12):1794-1803.

* 3. Hirata S, Dirven L, Shen Y, et al. A multi-biomarker score measures rheumatoid arthritis disease activity in the BeSt study. Rheumatology. 2013;52:1202-1207.

* 4. Eastman PS, Manning WC, Qureshi F, et al. Characterization of a multiplex, 12-biomarker test for rheumatoid arthritis. J Pharm Biomed Anal. 2012;70:415-424.