Facing CMS sanctions, lab industry insiders ponder the firm's options in seeking to launch a Zika virus assay with emergency use authorization on its upcoming miniLab platform.
The test was designed by diagnostics maker GenArraytion and uses the Luminex xMAP technology.
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.
At the American Association for Clinical Chemistry meeting, Theranos CEO Elizabeth Holmes said her company is working on third-party review and publications of the firm's technologies and tests.
The agency has doubled the window after suspected exposure during which it recommends RT-qPCR testing for some pregnant women.
The companies will work together to pursue US Food and Drug Administration clearance for a workflow combining Siemens' sample prep module and Thermo's qPCR instrument.
The firm also plans to launch its Versant MDx System sample prep module in the US next month for use with the test.
The new test distinguishes Zika from other viruses in mosquito vectors and launches during an ongoing outbreak that has prompted new CDC guidelines.