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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Co-Diagnostics Joint Venture Gets Clearance in India for Five MDx Tests

The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.

Genetron Health Gets China NMPA Approval for Clinical NGS System, Files for IPO

The Genetron Health S5 NGS system is based on the Thermo Fisher Scientific Ion GeneStudio S5 and will be accompanied by Genetron-developed assays.

Curetis Reports 17 Percent Revenue Increase for First Nine Months of 2019

The company also said that it expects a clearance decision from US regulators in the near term on a lower respiratory tract infection test that runs on its Unyvero system.

Genedrive Receives CE Mark for Hearing Loss Assay

The company's antibiotic-induced hearing loss test will be used to screen babies for a genetic mutation that can cause deafness when given certain antibiotics.

Myriad Genetics BRACAnalysis Approved by Japanese Regulators

Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.

Nov 20, 2019

T2 Biosystems Gets CE Mark for Direct-From-Blood Antimicrobial Resistance Panel

Nov 19, 2019

Despite FDA Clearance for NantHealth Test, Benefits of TMB Biomarker Unclear

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Nov 19, 2019

Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA

Nov 12, 2019

FDA Clears NantHealth Tumor-Normal Whole-Exome Test

Nov 12, 2019

Becton Dickinson Submits HPV Assay for Expanded US Premarket Approval

Nov 08, 2019

Biocept Receives CE Mark for Blood Collection Tube, Sample Collection Shipping Kit

Nov 08, 2019

Agilent's Magnis Joins Set-and-Forget Movement in Library Prep Instruments

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Nov 05, 2019

FindGene Noninvasive Prenatal Screening Kit Gets Approval from Chinese Regulators

Oct 29, 2019

FDA Approval of Myriad Genetics CDx Adds HRD to Growing List of Ovarian Cancer Predictive Markers

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Oct 24, 2019

UK Regulators Propose Blocking $1.2B Illumina, PacBio Deal

Oct 23, 2019

FDA Approves GSK's Zejula Alongside Myriad Genetics CDx for Advanced Ovarian Cancer

Oct 22, 2019

BioGx Gets CE-IVD Mark for Respiratory Infection Assay

Oct 14, 2019

Avellino Labs Gets CLIA Certification

Oct 11, 2019

New Coalition, Stakeholder Groups Push Back Against FDA 'Backdoor' Attempts to Regulate PGx Tests

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Oct 09, 2019

Mobidiag Gets CE Mark for Intestinal Parasites Test

Oct 02, 2019

Cepheid Xpert BCR-ABL Ultra Leukemia Monitoring Test Gets FDA Clearance

Sep 25, 2019

DiaSorin Molecular Gets CE Mark for VZV Swab Direct Molecular Test

Sep 24, 2019

Enzo Clinical Labs Gets NY State Approval for HBV Assay

Sep 23, 2019

FDA Expands Approval of Exact Sciences Colorectal Cancer Test to Younger People

Sep 20, 2019

Roche Gains FDA Clearance for Cobas Babesia Blood Test