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MDx/CDx Focus: Crescendo's Vectra DA Gets Medicare Coverage; Cobas HPV Test Supplemental PMA


Crescendo Garners Medicare Coverage for Vectra DA

Medicare contractor Palmetto GBA has agreed to reimburse for Crescendo Bioscience's Vectra DA multi-marker molecular diagnostic that assesses rheumatoid arthritis activity.

Vectra DA is a blood-based test that measures the levels of 12 proteins. Doctors can use this test in conjunction with standard clinical to track disease activity in RA patients. With the national coverage agreement between Crescendo and Palmetto, Vectra DA is now a covered benefit for Medicare beneficiaries.

The 12 immune, endothelial, bone, cartilage and metabolic biomarkers analyzed by Vectra DA are associated with RA biology. The test score, which ranges one and 100, helps doctors determine whether a patient has high, moderate, or low disease activity. Additionally, the molecule test can assist physicians in figuring out whether a patient is in clinical remission, is at risk of joint damage, is responding to various treatments, and is suffering from comorbidities.

Crescendo will perform Vectra DA testing through its CAP-accredited, CLIA-certified lab. The company earlier this year secured $28 million through a Series D financing round, which it is using to expand its sales force, educate rheumatologists about Vectra DA, and drive adoption and coverage of the test (PGx Reporter 1/9/2013). Medicare coverage represents a key milestone for Crescendo in increasing use of its flagship test.

Roche Files Supplemental PMA to Market Cobas HPV Test as First-Line Diagnostic

Roche has submitted a supplemental premarket approval application with the US Food and Drug Administration seeking to market its Cobas HPV Test as a primary screening tool for cervical cancer.

The FDA approved the Cobas HPV Test in 2011 as a tool to assess whether patients have high-risk Human Papillomavirus genotypes. Currently, the test is indicated for those 21-years or older with an abnormal Pap test, or meant to be used alongside a Pap test for women ages 30 to 65 years. The test gauges HPV 16 and HPV 18 genotypes, and reports 12 other HPV types as a pooled result.

In submitting the supplemental PMA, Roche wants to expand the use of the HPV test as the first-line test, rather than a tool that the doctor uses following or alongside Pap testing. As part of this submission, Roche provided FDA with three-year follow-up data from the ATHENA trial, which involved 47,000 women screened for cervical disease by Pap or HPV tests.

Data from ATHENA showed that nearly one in seven women with normal cytology who were HPV 16-positive had Grade 2 cervical intraepithelial neoplasia that was missed by cytology. Similarly, in the study, nearly one in eight women with normal cytology who were HPV 16-positive had Grade 3 cervical intraepithelial neoplasia missed by cytology.

Guidelines from the American Congress of Obstetricians and Gynecologists recommend HPV DNA testing for high-risk HPV 16 and HPV 18 for women with negative Pap test results but have tested positive for high-risk HPV by an assay that gauges 13 or 14 high risk types. Furthermore, other professional guidelines recommend that women with normal cytology who are HPV 16-positive or HPV 18-positive be considered for immediate colposcopy.