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Inside Precision Medicine Beckman Coulter Wins FDA Clearance for Access AMH Immunoassay

FDA policy

Beckman Coulter Diagnostics has won FDA clearance for its automated Access AMH fertililty immunoassay
Molecular Dx

Beckman Coulter Wins FDA Clearance for Access AMH Immunoassay

Inside Precision Medicine Staff Writer -
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Syringes and Target
Molecular Dx

Foundation One CDx Gets FDA Approval, Concurrent CMS Proposed Coverage Decision

Alex Philippidis -
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Novartis’ Kymriah™ (tisagenlecleucel) will be the first chimeric antigen receptor T-cell (CAR-T) cancer immunotherapy to reach the U.S. following FDA approval yesterday [Source: Novartis]
News & Features

FDA Approves Novartis’ Kymriah As First CAR-T Cancer Immunotherapy

Inside Precision Medicine Staff Writer -
0
Making notes for her thesis
News & Features

Snapshot: How to Address the FDA’s Proposed LDT Framework: Moving from CLIA to QSR

Walt Murray -
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DNA analysis: loading reaction mixture into 96-well plate with m
News & Features

FDA Seeks Methods to Better Regulate NGS Products

Jeffrey N. Gibbs -
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Quest's test is the first from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. [J.Gathany / CDC]
Molecular Dx

FDA Approves Quest’s Zika Test for Emergency Use

Inside Precision Medicine Staff Writer -
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Source: FDA
News & Features

AMP Seeks CLIA Update as FDA Pursues Lab Test Regulation

Inside Precision Medicine Staff Writer -
0
Advocacy groups have alleged that the FDA lacks statutory authority to regulate LDTs
Molecular Dx

Snapshot: LDT Labs Prepare for the Eventuality of FDA Oversight

Nina Peled, Ph.D. -
0
FDA Authorizes Marketing for 23andMe Bloom Syndrome Carrier Status Test
Molecular Dx

FDA Authorizes Marketing for 23andMe Bloom Syndrome Carrier Status Test

Inside Precision Medicine Staff Writer -
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FDA has concerns over the adequacy of the scientific evidence supporting the use of many laboratory developed tests. [Kasto/Fotolia]
Molecular Dx

Opinions Divided on Proposed FDA LDT Regulations

Chris Anderson -
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