"Including bacterial isolates in our FDA studies was a strategic decision — it provides hospital laboratories with flexibility and ensures that QuickMIC integrates seamlessly into existing ...

A slew of new studies and reports suggest that new molecular approaches may soon help reduce the global burden of tuberculosis.

Roche will receive rights to at least 1 billion lateral flow tests annually from Sapphiros as well as access to the company's future molecular testing technology.

The company intends to focus on custom partnerships around stroke, cancer, cardiovascular diseases and neurodegenerative diseases.

At the Association for Molecular Pathology annual meeting in Boston, stakeholders discussed regulatory and legislative priorities for the coming year.

Given the amount of tests that have required certification under the new system, the EU has staggered the grace periods for different classes of devices already holding CE-IVD marks obtained under the ...

Labcorp will acquire outreach labs serving patients in Indiana and northwest Ohio while Parkview will continue to operate labs serving acute and emergency needs.

The updated CE marking now enables labs in Europe to unify their workflows for both cell and tissue slide imaging and processing.

The Salt Lake City company said it has made "meaningful progress" on payor initiatives such as a pilot project in Nevada that is currently enrolling Medicaid patients.

NEW YORK – Precision oncology firm Personalis announced on Monday that its NeXT Personal test for minimal residual disease has received coverage from the US Centers for Medicare and Medicaid Services ...

The company said that recent study results show its Aventa Lymphoma test can provide actionable information that would typically be missed by FISH testing.