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The accreditation will help the company's facility move research findings more quickly into the clinical sphere.

The waiver opens up a significant new opportunity for Alere within the physician office market, according to a company executive.

Epic will now be able to participate in additional therapeutic clinical trials as a companion diagnostic partner.

Immune sequencing will be done in HudsonAlpha's newly established CLIA laboratory.

The Alere i Influenza A&B assay was originally cleared by FDA in June and the CLIA waiver means the test will be available in a wider variety of healthcare settings. 

Although lab industry players have talked of suing the FDA, it hasn't amounted to much more than just talk until this week, when ACLA announced it had retained two prominent lawyers to advise the group on LDT regulatory matters. President Alan Mertz discussed ACLA's legal options in an interview.

NEW YORK (GenomeWeb) – Before the US Food and Drug Administration's draft guidance on laboratory-developed tests (LDTs) can be finalized, the agency will need to iron out with industry players several areas of regulation that remain unclear and confront old issues around the agency's authority ov

NEW YORK (GenomeWeb) – US Senators are urging the Obama Administration to release draft guidance from the US Food and Drug Administration covering the regulation of laboratory-developed tests.


As the Canadian election season heats up, neither major party has really paid much attention to science, according to Nature News.

BBC News says the uncertainty over Brexit is affecting science funding in the UK.

A new app purports to tell users "how gay" they are by looking at their DNA, but experts tell Futurism that the app is bunk.

In Nature this week: human and great ape cerebral organoids reveal aspects of brain development unique to humans, and more.