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FDA submission

Tempus Submits PMA Application for Tumor Profiling Assay to FDA

The firm has submitted companion diagnostic and tumor profiling, and MSI status claims using DNA from FFPE tumor tissue and matched normal specimens.

Biocartis Files FDA Submission for Microsatellite Instability Test in Colorectal Cancer

The assay is intended to detect

Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib

The DRP would be used to identify kidney cancer patients likely to benefit from dovitinib, a repurposed TKI for which Allarity plans to file an NDA this year.

Startup Angstrom Bio Plans Saliva-Based COVID-19 Nucleic Acid Test on Nanopore Sequencing Platform
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Angstrom Bio is developing a rapid, scalable coronavirus test that uses nanopore sequencing to detect barcoded PCR products.

Adaptive Biotechnologies Prepares to Launch T Cell-Based COVID-19 Test
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Adaptive is rebranding its immunoSeq Dx assay as T-Detect and plans to submit for an EUA for a COVID-19 T-Cell response test by the end of the year.

Sep 28, 2020

Angle Files De Novo FDA Submission for CTC Collection Device in Breast Cancer

Sep 25, 2020

NIH Awardee MatMaCorp Developing SARS-CoV-2 Molecular Test for Rural Hospitals
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Sep 23, 2020

Becton Dickinson Submits Premarket Approval Supplement to FDA for HPV Assay

Aug 7, 2020

Illumina Sees Expanding Sequencing Market in COVID-19 Response, Despite Short-Term Woes
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Jul 20, 2020

Sepset Biosciences Leveraging COVID-19 Patient Samples in Study to Validate Sepsis Test
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Jun 16, 2020

Immunexpress Nabs $599K BARDA Contract to Develop Sepsis Test for Coronavirus Patient Triage

Jun 8, 2020

QuantuMDx Receives CE-IVD Marking for SARS-CoV-2 Test

May 29, 2020

Fry Laboratories Plans COVID-19 NGS Diagnostic Kit Offering
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May 13, 2020

Adaptive Eyes NGS-Based Test for T Cell Response in COVID-19
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Apr 14, 2020

Merck Bid for Second Pan-Cancer Keytruda Indication Would Raise Tumor Mutation Burden to CDx Status
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Apr 2, 2020

Siemens Healthineers Developing Molecular Kit for Coronavirus Detection

Mar 25, 2020

Sentinel Diagnostics Looks to Expand Global Influence With SARS-CoV-2 Test

Mar 11, 2020

Coronavirus Test From GenMark Diagnostics Submitted to FDA for Emergency Use Authorization

Feb 24, 2020

Luminex Submits Verigene II Respiratory Assay for FDA Clearance

Feb 20, 2020

FDA Releases List of Evidence-Based PGx Variants

Jan 21, 2020

Myriad Genetics Files for FDA Approval of BRACAnalysis CDx for Lynparza in Prostate Cancer

Jan 14, 2020

BioMérieux Submits 43-Target BCID2 Test to FDA

Nov 19, 2019

Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA

Sep 12, 2019

Applied BioCode Submits Respiratory Pathogen Panel to FDA

Jul 23, 2019

Curetis Submits Lower Respiratory Tract Infection Test for FDA Clearance

Breaking News
The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge is weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.