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PMA

Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test

The application is supported by data from the company's prospective trial, demonstrating 94 percent sensitivity for CRC in an average-risk cohort.

FDA Accepts Invitae Premarket Approval Submission for Stratafide Companion Diagnostic

The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.

BD Receives FDA Supplemental Premarket Approval for Extended Genotyping HPV MDx

The expanded test can be used for genotype risk-based patient monitoring to prevent over-treatment, BD has said.

Invivoscribe Receives Supplemental Approval for AML Kit

The firm has received a supplemental approval that provides its customers with an option to purchase its IVD-labeled FLT3 mutation assay for in-house testing.

GSK Gets Broad Zejula Indication in Ovarian Cancer; FDA Deems Myriad Genetics' Test Complementary

The drugmaker will promote Zejula without a biomarker as a first-line maintenance option, and Myriad will highlight that patients with HRD are most likely to benefit.

Apr 28, 2020

Caris Life Sciences Seeks FDA Approval for Exome, Transcriptome CDx Assays

Apr 1, 2020

FDA Proposes Reclassification of HCV RNA, Antibody Tests

Feb 11, 2020

Myriad Files sPMA With FDA for Test to ID Best Responders to Lynparza, Avastin Combination

Jan 23, 2020

Myriad Genetics Seeks Supplemental Approval of HRD Test as CDx for GSK Ovarian Cancer Drug

Nov 12, 2019

Becton Dickinson Submits HPV Assay for Expanded US Premarket Approval

Aug 7, 2019

Myriad Genetics Seeking Additional FDA Approval for BRACAnalysis CDx

Apr 9, 2019

Myriad Submits MyChoice HRD as Companion Diagnostic for GSK's Zejula

Oct 16, 2018

FDA Approves Myriad Genetics BRCA CDx With Pfizer's Metastatic Breast Cancer Drug

Jun 18, 2018

Myriad Genetics Submits Supplementary PMA for BRACAnalysis CDx

Apr 19, 2018

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

Jan 25, 2018

FDA Grants Approval for Hologic Hepatitis B Viral Load Assay

Oct 18, 2017

FDA Accepts Myriad BRACAnalysis CDx Supplementary PMA for Lynparza in Breast Cancer Indication

Aug 1, 2017

Abbott Receives FDA Approval for IDH2 Mutation CDx Alongside AML Drug

Jun 22, 2017

Thermo Fisher Next-Gen Sequencing Panel Wins FDA Approval as Companion Test

Mar 20, 2017

Siemens Healthineers Gets FDA Premarket Approval for HCV Genotyping Test

Feb 16, 2017

Hologic HCV Assay Wins FDA Premarket Approval

Nov 14, 2016

Thermo Fisher Submits Premarket Approval Application to FDA for Sequencing-Based Companion Dx

Nov 2, 2016

Myriad Moving Ahead With PMA Filing for MyChoice HRD as Companion Test for Niraparib
Premium

Dec 4, 2015

In Brief This Week: Pacific Biosciences; Epigenomics; Cynvenio Biosystems; and More

Jul 30, 2015

Roche Files PMA for Updated Cobas EGFR Test as CDx for AstraZeneca's AZD9291

Breaking News
The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.