The test runs on Roche's LightCycler 480 instruments or Cobas z 480 analyzers.
The new guidance could benefit Hologic and Roche, both of which market molecular blood screening tests authorized by the FDA under an investigational new drug study protocol.
Last week, the G-BA, a committee that decides about reimbursable medical services in Germany, said it will start a methods evaluation of noninvasive prenatal testing.
The firm has made a series of acquisitions and entered into strategic collaborations over the past couple of years aimed at rapidly growing its MDx offerings.
Laboratories have access to a growing number of antibody and molecular tests, thanks in part to FDA Emergency Use Authorizations, but they need more serology resources.
While undergoing parallel review for its FoundationOne test by the FDA and CMS, the firm will continue to work with its local MACs on reimbursement.
The company also said that its FoundationOne test has been accepted for parallel review as part of the Expedited Access Pathway program with the FDA and CMS.
Despite the array of tests available, some lab directors are still seeking broader functionalities and capabilities from the systems they purchase.
Representatives from industry, academia, the FDA, and insurance companies gathered for a joint FDA- and American Association for Cancer Research-sponsored workshop.
The Swiss firm also reported an 8 percent year-over-year increase in diagnostics sales in the second quarter at constant exchange rates.