The firm's CEO said it is continuing to develop its distributor network to make its tests available in centralized and decentralized settings globally.
The anticipated shortage for clinics comes at a time when more clinicians are already switching to lab-based IGRA testing, diagnostic industry executives said.
iCubate said that it now has a comprehensive solution within European markets for the detection of bloodstream bacteria and important resistance markers.
The closure has no impact on the firm's other Los Gatos location, the original home of GeneWeave Biosciences, which Roche acquired in 2015 for up to $425 million.
The firm said that its multiplex point-of-care test uses 10 microliters of blood from a fingertip and provides quantitative results in about 15 minutes.
Stakeholders discussed last year's decision by Palmetto to deny coverage for large respiratory panels and discussed the way forward for test developers and labs.
McKesson will be the exclusive distributor of the QiaStat-Dx system in US hospitals with fewer than 200 beds and non-exclusive distributor for future expansion into retail pharmacy clinics.
Some at-home infectious disease tests and sample collection kits exist in a murky regulatory realm, and their sale to patients is troubling laboratorians and clinicians.
The firm is starting a trial that it anticipates will lead to an application for marketing clearance with the US Food and Drug Administration by next year.
