Diagnostics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

Bio-Rad Clinical ddPCR Test, Diagnostic System Get FDA Clearance

The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.

Hologic Aptima HIV-1 Assay Receives Dual Claim CE Marking

The assay's CE marking permits its use for the early diagnosis of HIV-1 in infants and for measuring viral load and disease progression using dried blood spot samples.

CMS Proposes Adding 29 New Analytes in Update of CLIA Proficiency Testing Rules

Proficiency testing providers told CMS last year that an update to the rule, which has not been changed since 1992, is long overdue.

Bioneer HIV-1 Dx Kit Gets Korea FDA Approval

The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.

GenomeDx Biosciences to Pay $2M to Settle Allegations of Improper Medicare Billing

The federal government said GenomeDx billed Medicare for its Decipher Biopsy prostate cancer genome classifier on behalf of patients who didn't need the test.

Feb 11, 2019

Q&A: OIR Director Timothy Stenzel Discusses Precision Medicine Efforts During First Year at FDA

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Feb 08, 2019

Sysmex, Beckman Coulter, Thermo Fisher Scientific, Others Receive FDA Clearances in January

Feb 07, 2019

Grifols Gets FDA Approval for Babesia Assay

Feb 05, 2019

Japanese Regulators Approve Promega CDx for Merck's Keytruda

Feb 04, 2019

Curetis Partner Submits MDx System, Pneumonia Test for Chinese Regulatory Approval

Jan 31, 2019

Kurin Wins FDA Clearance for Blood Collection System With Infusion Set

Jan 30, 2019

Curetis Receives Malaysia, Thailand Regulatory Approvals

Jan 30, 2019

FDA Clears Oxford Gene Technology FISH Probes

Jan 25, 2019

FDA Clears PTS Diagnostics Kit For Measuring Analytes in Whole Blood

Jan 24, 2019

NuGenerex Gets CE Mark for Point-of-Care Syphilis Assay

Jan 23, 2019

Hologic M. Genitalium Assay Gets FDA De Novo Clearance

Jan 22, 2019

23andMe Gets FDA Approval for Genetic Risk Report on Hereditary Colorectal Cancer Syndrome

Jan 22, 2019

FDA's Move to Modernize 510(k) Process Welcomed by Some; Others Stress Caution

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Jan 17, 2019

FDA Finalizes Guidance on Coordinated Development of Antimicrobial Drugs, Susceptibility Tests

Jan 16, 2019

Qiagen EGFR Assay Approved in Japan as CDx to Pfizer NSCLC Drug

Jan 16, 2019

Theradiag Gets CE Mark for Cosentyx Response Kit

Jan 15, 2019

BioMérieux, DiaSorin, GenMark, and Others Receive FDA Clearances in December

Jan 14, 2019

Qiagen Next-Gen TB Test Gets Health Canada Approval

Jan 08, 2019

Grifols Blood Typing Solution Approved by FDA

Jan 08, 2019

Phosphorus Gets NY Clinical Lab Permit, Test Approvals