POC test market reaches $29.3B as COVID-19 revenues boom
April 20, 2021 -- In 2020, sales of point-of-care (POC) testing reached $29.3 billion, according to Kalorama Information, a sister publication to LabPulse.com. New COVID-19 tests fueled growth while the pandemic ravaged business in other test categories. Read More
Lucira Health assay spots 'double mutant' COVID-19 variant
April 9, 2021 -- Lucira Health said it can successfully identify the "double mutant" variant of COVID-19 with its Lucira molecular test kit. Read More
Hologic acquires Mobidiag for $795M
April 8, 2021 -- Hologic announced it has agreed to acquire Mobidiag, a privately held, commercial-stage Finnish-French developer of innovative molecular diagnostic tests and instrumentation. Read More
Nucleix secures $55M in funding for lung cancer test
April 7, 2021 -- Liquid biopsy company Nucleix has secured $55 million to advance Lung EpiCheck, an early detection lung cancer test based on methylation technology. Read More
FDA clears Binx Health's chlamydia, gonorrhea POC assay
April 2, 2021 -- The U.S. Food and Drug Administration is allowing Binx Health's IO Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay to be used at point-of-care (POC) settings, such as physician offices, community-based clinics, urgent care settings, and outpatient healthcare facilities, to test for chlamydia and gonorrhea. Read More
Menarini introduces multiple myeloma assay
April 1, 2021 -- Menarini Silicon Biosystems has launched the CellSearch Circulating Multiple Myeloma Cells Assay. The new test will assist pharmaceutical companies, contract research organizations, clinicians, and research scientists working on multiple myeloma. Read More
Qiagen secures EUA for COVID-19 test
March 29, 2021 -- Qiagen has received emergency use authorization (EUA) from the U.S. Food and Drug Administration for NeuMoDx, a test that helps clinicians distinguish types of respiratory disease. Read More
Thermo Fisher to launch new qPCR system
March 25, 2021 -- Thermo Fisher Scientific announced it has completed a U.S. Food and Drug Administration listing to launch its Applied Biosystems QuantStudio 5 Dx real-time polymerase chain reaction (qPCR) system. The new system simplifies molecular diagnostic workflows for infectious disease, oncology, and COVID-19 testing, according to the company. Read More
FDA approves new uses for Natera's MRD test
March 24, 2021 -- The U.S. Food and Drug Administration (FDA) has granted two breakthrough device designations covering new intended uses for Natera's Signatera molecular residual disease (MRD) test. Read More
Rosalind launches web-based SARS-CoV-2 variant tracker
March 23, 2021 -- Rosalind has launched a web-based platform called Rosalind Diagnostic Monitoring for tracking SARS-CoV-2 variants and evaluating their effects on diagnostic tests. Read More