FDA submission

Tempus Submits PMA Application for Tumor Profiling Assay to FDA

Biocartis Files FDA Submission for Microsatellite Instability Test in Colorectal Cancer

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

Meridian Bioscience Submits Curian Campylobacter Assay to FDA

Fujirebio Diagnostics Applies for FDA 510(k) Clearance for Alzheimer's Disease Test

Startup Angstrom Bio Plans Saliva-Based COVID-19 Nucleic Acid Test on Nanopore Sequencing Platform

Adaptive Biotechnologies Prepares to Launch T Cell-Based COVID-19 Test

Oxford Immunotec Files FDA Submission for TB Test Sample Prep Kit

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

Biovica Files FDA 510(k) Submission for Breast Cancer Treatment Response Assay

NIH Awardee MatMaCorp Developing SARS-CoV-2 Molecular Test for Rural Hospitals

Becton Dickinson Submits Premarket Approval Supplement to FDA for HPV Assay

Blood Collection Firm Tasso Seeking to Enable At-Home Coronavirus Antibody Tests

With One Eye on COVID-19, The Other on TBI, NanoDx Pushes Ahead with Nanowire-Based Technology

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

Sepset Biosciences Leveraging COVID-19 Patient Samples in Study to Validate Sepsis Test

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

BARDA Awards Funding to Quidel, Siemens Healthineers for Development of Coronavirus Tests

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