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CLIA

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NEW YORK (GenomeWeb) – Before the US Food and Drug Administration's draft guidance on laboratory-developed tests (LDTs) can be finalized, the agency will need to iron out with industry players several areas of regulation that remain unclear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NEW YORK (GenomeWeb) – US Senators are urging the Obama Administration to release draft guidance from the US Food and Drug Administration covering the regulation of laboratory-developed tests.

NEW YORK (GenomeWeb) — Early-stage molecular diagnostics developer Mesa Tech International has been awarded $1 million from the National Institutes of Health to further develop its low-cost nucleic acid testing device for respiratory disease diagnosis.

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23andMe is offering early customers re-testing on newer chips for a fee, Wired reports.

He Jiankui is no longer affiliated with Direct Genomics Biotechnology, the single molecule sequencing company he founded, Nikkei Asian Review reports.

Newsweek writes about the hopes for precision medicine in cancer, but also challenges getting it to patients.

In Genome Research this week: genomic architecture of glioblastoma, predictive computational approach to estimate SNP fitness, and more.