Most commonly associated with test analysis, such tools are also seeing uptake by large reference labs for applications like specimen routing and billing support.
With $10 billion in federal funding supporting school screening, labs, vendors, and various other institutions are ramping up efforts to roll out K-12 testing programs.
While the reforms ease some providers' shift to value-based care, their exclusion of labs could hamper the industry's move into population health and other areas.
The blood test is the lead product for the Palo Alto, California-based company, which in 2018 purchased the assets of defunct proteomics outfit Applied Proteomics.
FDA has signaled via public comments that it is flexible on test performance specs, but firms remain wary of falling short of official agency requirements.
In one of the first projects to study large-scale antigen testing, the assays detected a significant number of cases but had little apparent effect on overall rates.
