Ciara Curtin

The panels assess genes with strong disease links and clinical management guidelines, but the firm offers limited-evidence genes as an add-on option.

At the meeting, clinical microbiologists wondered how to convey their concerns to the agency, and how it would address aspects of the rule that are vague.

A recent analysis found that it can take between five days and more than a year from when testing is first considered to sample collection.

Lab geneticists are raising concerns as the US Congress is expected to take up a bill that would change how the Food and Drug Administration oversees LDTs.

The Swedish firm Biovica said this and additional studies will form the basis of a US Food and Drug Administration submission for its test measuring thymidine kinase-1.

The researchers said a microbiome-based test could expand the number of individuals who are screened for the disease.

The similar analytic performance of LDTs and FDA-approved tests informs the ongoing debate about the regulation of in vitro testing.

Researchers from the US and UK used a combination of genetic and metabolomics analyses to home in on methylthioadenosine as sepsis biomarker.

The firm has seen a small handful of false positives for the test in thousands of samples run since the study, but attributed them to biological features.

Among people with a wheeze, the test people can identify people with asthma, but among the asymptomatic public, it is better at identifying people who don't have asthma.