Logo

FDA

Leqembi Approval Likely to Drive Changes in APOE Testing Landscape
Premium

FDA's recommendation that Alzheimer's patients be tested for APOE status prior to starting the drug could lead to new regulatory approvals and payor coverage.

FDA Approves Foundation Medicine CDx for Use With Janssen Drug in Prostate Cancer Patients

The test will be used as a companion diagnostic for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.

Experts Call for Better FDA Policing of Direct-to-Consumer Polygenic Risk Scores

In a commentary in the Journal of the American Medical Association, experts described health concerns related to direct-to-consumer polygenic risk score services.

Invivoscribe Gets FDA Approval for LeukoStrat CDx for Daiichi Sankyo Leukemia Drug

The PCR-based test detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.

At FDA and in Utah, Transparency Projects Probing Lab Test Quality in Cancer Care
Premium

The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk.

Jun 26, 2023

Top Five Articles on GenomeWeb Last Week: Illumina Ventures; Exact Sciences; ACMG; More

Jun 20, 2023

FDA Launches Pilot Program to Determine Performance Criteria for Lab-Developed CDx Tests

Jun 12, 2023

FDA Grants Emergency Use Authorization for Michigan State University COVID-19 Molecular Assay

Jun 9, 2023

Foundation Medicine Blood Test Gets FDA Approval as CDx for Pfizer's Braftovi in Colorectal Cancer

Jun 9, 2023

Acutis Diagnostics Gets FDA Emergency Use Authorization for COVID-19 RT-PCR Test

Jun 6, 2023

FDA Grants Marketing Authorization for Cue Health COVID-19 At-Home Molecular Test

May 23, 2023

T2 Biosystems Lays off 30 Percent of Workforce as Q1 Revenues Drop 71 Percent

May 5, 2023

FDA Issues EUAs for COVID Molecular Tests From Access Medical, Drexel University

May 4, 2023

Nucleix Bladder EpiCheck Cancer Liquid Biopsy Test Gets FDA 510(k) Clearance

May 1, 2023

Tempus Gains FDA Premarket Approval for NGS Solid Tumor Profiling Test

Apr 27, 2023

Illumina Sequencers Face Cybersecurity Vulnerability, FDA Warns

Apr 27, 2023

FDA Grants Emergency Use Authorization for UMass Amherst COVID-19 Molecular Test

Apr 6, 2023

LungLife AI Readies Pivotal Study of Lung Cancer Liquid Biopsy Assay, Seeks FDA Approval
Premium

Mar 20, 2023

Cue Health Gets FDA EUA for Monkeypox Molecular Test

Mar 20, 2023

DiaSorin Gets FDA 510(k) for Molecular COVID-19/Flu Assay

Mar 14, 2023

Visby Medical Point-of-Care STI Test Gets FDA 510(k) Clearance, CLIA Waiver

Mar 14, 2023

Quest Diagnostics Gets FDA Emergency Use Authorization for COVID-19 Sample Collection Kit

Mar 6, 2023

As Pandemic Wanes, Firms That Rode COVID-19 Testing Wave Struggle for Solid Footing
Premium

Feb 24, 2023

Lucira Health OTC, At-Home COVID/Flu Test Gets FDA EUA Days After Firm Files for Bankruptcy

Feb 16, 2023

FDA Winding Down COVID, Mpox Test Emergency Use Authorizations

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.