The firm also said it will wind down its microbiome laboratory and analytical sequencing services business, yielding expected annual cost savings of $10 million.

The man had, among other things, fraudulently billed Medicare and other healthcare benefit programs for medically unnecessary cancer genomic tests.

The firm reported rising revenues across its prenatal, pharmacogenomics, and hereditary cancer testing businesses, although its tumor profiling business dipped year over year.

The new agreement builds on a previous partnership to develop a MeMed immunoassay for Beckman's Access family of analyzers.

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 firm reported rising non-COVID diagnostics revenues in the EMEA and Americas regions plus gains from an ongoing transformation program.

Last week, readers were most interested in a story about the release of FDA's final rule for regulating laboratory-developed tests.

The hub will support the development of diagnostics and medical devices to detect, prevent, or respond to medical consequences that result from health security threats.

The Tennessee-based firm is combining molecular and protein testing technologies that it brought under one roof in a pair of deals last summer.

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