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Local Coverage Determinations Roundup: Aspira Labs, Fujirebio Diagnostics

This story originally misstated the Medicare Administrative Contractor that released the decision. We regret the error. 

NEW YORK – Medicare Administrative Contractors released draft local coverage determinations (LCDs) for a number of molecular diagnostics this week.

Below is a list and brief description for each of the LCDs. Each listing starts with the Medicare contractor that made the decision.


Final LCDs:

National Government Services: Aspira Labs' Ova1, Overa; and Fujirebio Diagnostics' ROMA

National Government Services issued a non-coverage determination for all multi-marker serum tests related to ovarian cancer testing. Aspira Labs' Ova1 and Overa tests, as well as Fujirebio Diagnostics' ROMA test are three serum tests cleared by the US Food and Drug Administration and reviewed in the policy. According to the contractor, none of the multi-marker serum tests addressed in the policy have been proven to reliably screen, improve quality of life, or decrease mortality in patients with ovarian cancer. Given the limitations of currently available data on these tests, and the positions of multiple professional societies and the National Cancer Institute, National Government Services said that data from non-industry funded, large prospective studies showing an impact on long term outcomes, such as survival, would be needed for coverage.  

Aspira is a subsidiary of Vermillion. The OVA1 test is a multivariate index assay that assesses the levels of blood-based biomarkers that are associated with ovarian cancer. Overa is a second-generation ovarian cancer test with higher specificity than OVA1.

The ROMA test is a risk stratification tool that combines CA125, HE4, and menopausal status into a numerical score to indicate the risk of malignancy for pelvic masses.