Key Coverage Determinations and Product Developments

Although several companies secured favorable diagnostic coverage determinations in March, the big winner was Vermillion, manufacturer of the OVA1 ovarian cancer early detection test—the test covered in a recently extended commercialization agreement between Vermillion and Quest. On March 1, Vermillion announced that Aspira Labs, the wholly-owned subsidiary that manufactures the test, had secured a major contract for OVA1 with Blue Cross Blue Shield of Michigan. Less than a week later, Aspira Labs was granted Medi-Cal (the California Medicaid program) out-of-state provider status, effectually expanding OVA1 access to 12 million new patients.

Diagnostic firms whose products achieved significant approvals in March included:

• OncoCyte, which reported that its early lung cancer detection test achieved favorable results in a 300-patient study ahead of a planned launch for the second half of 2017;
• Agendia, whose MammaPrint 70-gene signature test measuring risk of breast cancer recurrence received a1A label, the highest medical evidence level granted under German Association of Gynecological Oncology guidelines; and
• Beckman Coulter Diagnostics, which announced the FDA clearance and commercial launch of its DxC 700 AU chemistry analyzer.

For more information about the latest deals and other industry developments, see “Diagnostic Deals” the March issue of Laboratory Industry Report.