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More articles about Regulatory News

Jun 06, 2018

FDA Grants Breakthrough Designation for AutoGenomics' Infiniti Neural Response Panel

The designation will help the company accelerate the process of bringing the opioid addiction risk test through regulatory review and clearance.

Jun 05, 2018

FDA Lifts Some Regulatory Hurdles for Genetic Health Risk Tests as Planned

Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.

Jun 04, 2018

Micronics Gets FDA Clearance for MDx System, E. Coli Test

The test is Micronics’ first to receive FDA clearance, and the company is pursuing CE marking for it and the PanNAT system.

Jun 04, 2018

China FDA Approves Vela Diagnostics Cell-Free DNA Kit

The China FDA has approved Vela's cell-free DNA extraction kit, which can be coupled with RT-PCR or NGS workflows for further analysis.

May 30, 2018

European Data Protection Law Brings New Responsibilities, Possibilities for Genomics Researchers

Premium

Consent — and the right to withdraw it — underlies the EU's newly effective General Data Protection Regulation for researchers in Europe and beyond.

May 25, 2018

BioGx Gets CE Marking for Six Meningitis, Antibiotic Resistance Tests

BioGx now offers 11 CE-marked infectious disease tests that run on Becton Dickinson's BD Max platform.

May 21, 2018

IncellDx Gets CE Mark for HPV Assay

IncellDx HPV OncoTect 3Dx system combines the quantification of oncogene mRNA overexpression, proliferation, and aneuploidy in one high-throughput assay, according to the firm.

May 15, 2018

Genetic Signatures Gets OK From Australian Authority for 'Superbug' Kit

The kit, designed to rapidly detect 16 beta-lactam and carbapenem-resistant pathogen targets, was CE marked last month.

May 14, 2018

FDA Approves Additional Claim for Roche Zika Test

The claim, enabling streamlined screening of pooled samples, follows updated industry recommendations for Zika virus screening in the US blood supply.

May 04, 2018

FDA Recommends Precertification Program to Legislators as They Consider Dx Regulatory Reform

The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.

Apr 24, 2018

Applied BioCode Gets CE Mark for MDx Platform, GI Panel

The company submitted the platform and gastrointestinal panel to the US Food and Drug Administration for clearance earlier this year.

Apr 19, 2018

FDA Expands Approval of Roche Cobas Test as CDx for EGFR Deletions, Mutations

The FDA approved its use with tissue or plasma biopsies, giving clinicians a non-invasive option to conduct a test that provides results in a day.

Apr 19, 2018

Curetis Gets CE Mark for UTI Test

The test cartridge runs on the company's Unyvero platform and covers 103 diagnostic targets for various pathogens and markers of antibiotic resistance.

Apr 16, 2018

FDA Clears Roche CT/NG Assay for 6800, 8800 Systems

The firm said that its Cobas CT/NG real-time PCR assay is the first available in the US for the testing of sexually transmitted infections on its 6800 and 8800 systems.

Apr 16, 2018

Cancer Genetics Wins 510(k) Clearance for Tissue of Origin Test

The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.

Apr 12, 2018

FDA Finalizes NGS Guidances; Proposes Guidance on Investigational IVDs in Cancer Rx Trials

The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.

Apr 04, 2018

Curetis Unyvero System, Lower Respiratory Tract Infection Cartridge Get FDA Clearance

The firm also received approval from the Singapore Health Sciences Authority to market the Unyvero blood culture cartridges.

Apr 02, 2018

Japanese Regulators Approve Myriad Genetics' BRACAnalysis Test

The test is approved as a companion diagnostic that can determine which advanced breast cancer patients have BRCA1/2 genetic mutations and will likely respond to Lynparza.

Mar 28, 2018

Fast Track Diagnostics Gets CE Mark for Real-Time PCR Detection of High-Risk HPV

The firm has launched a multiplex real-time PCR assay that detects HPV 16, HPV 18, and a pool of 12 other high-risk HPV subtypes.

Mar 15, 2018

Castle Bio Gets NY State Approval for Three Cancer Tests

The approvals allow the company to offer its PCR-based expression profile cancer risk tests in the state.

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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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