510(k)

Roche Lipoprotein (a) Test Receives FDA 510(k) Clearance

The test, which is intended for assessing cardiovascular risk, is the first lipoprotein (a), or Lp(a), test measured in nanomoles per liter to receive FDA clearance.

FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.

FDA Approves Thermo Fisher Scientific HLA Typing Kit as CDx for Adaptimmune T-Cell Receptor Therapy

Adaptimmune's therapy is intended to treat patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy.

Proscia Nabs US FDA 510(k) Clearance for Digital Pathology Software

The firm's digital pathology software is used to aid analysis of whole-slide images for the primary diagnosis of cancer.

GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test

The test recently received a CPT PLA code and is currently offered through GenInCode's laboratory in Irvine, California.

Mar 2, 2023

Biocartis Nabs FDA 510(k) Clearance for Lynch Syndrome Screening Assay

Oct 27, 2022

23andMe Gains FDA Clearance for Simvastatin Pharmacogenetic Report

Jan 10, 2022

23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test

Jul 29, 2021

NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test

Jan 28, 2020

Study IDs Biomarker of Treatment Efficacy for CDK 4/6 Inhibitors in Breast Cancer; FDA Filing Planned
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Nov 12, 2019

FDA Clears NantHealth Tumor-Normal Whole-Exome Test

Nov 20, 2017

510(k)

Roche Lipoprotein (a) Test Receives FDA 510(k) Clearance

FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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FDA Approves Thermo Fisher Scientific HLA Typing Kit as CDx for Adaptimmune T-Cell Receptor Therapy

Proscia Nabs US FDA 510(k) Clearance for Digital Pathology Software

GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test

Biocartis Nabs FDA 510(k) Clearance for Lynch Syndrome Screening Assay

23andMe Gains FDA Clearance for Simvastatin Pharmacogenetic Report

23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test

NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test

Study IDs Biomarker of Treatment Efficacy for CDK 4/6 Inhibitors in Breast Cancer; FDA Filing Planned
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FDA Clears NantHealth Tumor-Normal Whole-Exome Test

Labs Mull New Regulatory Path for NGS Tumor Panels in Wake of FDA Decision on MSK-IMPACT
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Legend, Janssen Will Invest $150M to Expand Carvykti Manufacturing in Europe

BMS's Breyanzi Gains European Approval as Third-Line Treatment for Follicular Lymphoma

RedHill Biopharma to Launch Phase II Trial of Crohn's Disease Drug in Biomarker-Defined Population

In Brief This Week: Count Me In, TeleRare Health, VolitionRx, Ascentage, Atsena, ClearNote Health

PDS Biotech Cleared to Begin Trial of Immunotherapy Combo in MUC1-Positive Colorectal Cancer

MeiraGTx, Hologen Tackle CNS Disorders With AI Drug Development Joint Venture

510(k)

FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain Premium

Study IDs Biomarker of Treatment Efficacy for CDK 4/6 Inhibitors in Breast Cancer; FDA Filing Planned Premium

Labs Mull New Regulatory Path for NGS Tumor Panels in Wake of FDA Decision on MSK-IMPACT Premium

FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
Premium

Study IDs Biomarker of Treatment Efficacy for CDK 4/6 Inhibitors in Breast Cancer; FDA Filing Planned
Premium

Labs Mull New Regulatory Path for NGS Tumor Panels in Wake of FDA Decision on MSK-IMPACT
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