The firm has been placing point-of-care systems primarily in the private sector, but may have increased access once it completes WHO prequalification review.
The assay was shown to have a simpler workflow and was able to detect mosaicism, with only a slight decrease in sensitivity compared to a lab-developed test.
The Ann Arbor, Michigan-based firm will compete with a few well-established players offering systems that can run in vitro diagnostic tests as well as lab-developed tests.
The San Diego-based firm's diagnostic system uses spatial thermal cycling and a proprietary liquid metal bath for temperature control for five-minute multiplexed PCR assays.
In PLOS this week: similar variants seen in bullbogs, people with Robinow syndrome; ApoE genotypes in African-American, Puerto Rican populations; and more.
