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Aug 08, 2018

FDA Details Vision for Regulating In Vitro Clinical Tests to Legislators

The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.

Jul 26, 2018

Cepheid Flu/RSV Test Gets FDA Clearance, CLIA Waiver

The test, which uses automated reverse-transcription real-time PCR, expands the firm's menu of CLIA-waived tests for use in near-patient and point-of-care settings.

Jul 16, 2018

Predicine Gets CLIA Certification for Sequencing Lab

The company is developing a proprietary technology for the detection of RNA- and DNA-based genetic alterations in blood samples.

Jun 22, 2018

Some Stakeholders Not on Board With Draft Bill on New Dx Regulatory Framework

Premium

Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.


Jun 20, 2018

Deletion Is Hard to Do

A Bloomberg reporter tried to get her genetic data deleted, but found it's not so simple to do.

May 02, 2018

Cepheid Xpert Xpress Strep A Test Gets CLIA Waiver

The test, which received FDA clearance in late 2017, runs in as little as 18 minutes.

May 01, 2018

Novogene Gets CLIA Certification for US Lab

The lab is located within Novogene's sequencing center at the Sacramento campus of the University of California, Davis.

Jan 09, 2018

Cepheid GeneXpert Xpress, Influenza MDx Receive FDA 510(k) Clearance, CLIA Waiver

The Xpert Xpress Flu can detect both influenza A and B virus in 20 minutes from either nasopharyngeal or nasal swabs.

Dec 22, 2017

Quidel Solana GBS, Sofia2 Group A Strep Tests Clear FDA

The firm's Group A Strep test for use on its Sofia2 analyzer also received CLIA waiver from the agency.

Nov 28, 2017

Celmatix Receives NY State Approval for Reproductive Health Gene Panel

The firm has secured NYS approval for its sequencing-based 32-gene Fertilome assay, which it originally launched in January. 

Pages

The Scan

Closely Intertwined

The New York Times and ProPublica look into the close relationship between a startup and Memorial Sloan Kettering Cancer Center.

Little From Here and There

Yahoo News reports millions of dollars are being transferred from NIH, CDC, and other programs to pay for the housing of detained undocumented immigrant children.

This Week in Science

In Science this week: in vitro generation of human reproductive cells, and more.

All the Arms for Hugging

Researchers gave a handful of octopuses MDMA to find that they too act more social on the drug, Gizmodo reports.

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