The agency also cleared Roche's assay for diagnosing thyroid or pituitary disorders, as well as tests from Beckman Coulter, Immunostics, and BioMérieux.
A report from Leerink predicted Thermo Fisher Scientific could launch such a system within the next year, potentially opening up the clinical mass spec market.
Cepheid noted that the cartridge is not currently part of its five-year commercial plan, but the firm is in discussions with outside parties to push development forward.
