Ciara Curtin

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.

The model could shift which patients receive gene expression profiling assays but might not change the number of tests ordered.