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510(k)

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 companies are positioning the test, called SeptiCyte Rapid, for use in triaging COVID-19 patients who could be at greater risk for progressing to sepsis.

 

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.

The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.

The firm said its panel, which runs on its MDx-3000 system, tests nasopharyngeal swabs for the most common viruses and bacteria.

The LRT BAL panel detects a wide spectrum of clinically relevant causative agents, such as atypical pathogens and antibiotic resistance markers.

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Bloomberg reports the US Centers for Medicare & Medicaid Services sent Orig3n a letter saying it has not corrected lab issues uncovered in an earlier inspection.

In an editorial at BMJ Opinion, two genetic counselors call for an increased focus on post-test patient care.

A new survey finds people in the US are getting their COVID-19 test results back faster, but not fast enough to help some viral control measures, NPR reports.

In PLOS this week: genomic analysis of malaria parasites in Ethiopia, loci linked to childhood BMI, and more.