The rule makes explicit that LDTs are in vitro diagnostics and as such are subject to oversight by FDA under the Federal Food ...

DeepUll showcased its UllCore platform and UllCore BSI Test, a one-hour multiplex PCR assay targeting 95 percent of ...

As demonstrated during the COVID-19 pandemic and in newer research, saliva holds promise as an alternative sample type for ...

The new test joins Abbott's existing portfolio of laboratory-based tests that utilize the same neurology biomarkers.

The cases could overturn a legal principle known as the "Chevron doctrine" under which courts have typically deferred to ...

The core features have stayed consistent as GenMark is "dedicated to the syndromic approach" and remains focused on infectious diseases, a Roche executive said.

While the parasitic infection is primarily spread through insect vectors, it can also be transmitted congenitally and is often asymptomatic in newborns.

Infectious disease firm Karius announced on Thursday that it has raised $100 million in a Series C financing round with new and existing investors. The funding round ...

Of the 30 companies in the index, six companies saw their share price rise last month, while 24 companies saw their stock prices decline.

With a leaner team and budget, the program aims to accelerate novel diagnostics that fill unmet needs while also propagating its model throughout other NIH divisions.

The company's CEO stepped down in March as the firm began a business review to determine its strategic direction.

The test is a cell-based neutralizing antibody assay that detects preexisting anti-AAVRh74var antibodies that could impact patient safety or the efficacy of treatment.