510(k)

The firm said it intends to apply to obtain FDA Emergency Use Authorization and 510(k) clearance for a panel that detects respiratory targets in a single test.

The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients.

The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.

The company first submitted for 510(k) clearance last year and has received two additional information requests from the agency.

The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.

The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.

The firm can now tell customers if their genotypes may impact their response to clopidogrel and citalopram without the need for confirmatory testing.

The FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.

If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.