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.