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
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
New AI-powered imaging tool estimates hemoglobin levels
March 2, 2021 -- A novel chip-based microfluidic diagnostic platform, featuring a microfluidic chip and an artificial intelligence (AI)-powered automated microscope, can estimate hemoglobin levels in whole blood samples less expensively than hematology analyzers, according to research published February 23 in AIP Advances. Read More
Thermo Fisher completes Mesa Biotech acquisition
February 26, 2021 -- Thermo Fisher Scientific has completed its previously announced acquisition of point-of-care molecular diagnostics provider Mesa Biotech. Read More
PerkinElmer unveils COVID-19 rapid antigen test
February 23, 2021 -- PerkinElmer has launched a lateral-flow immunoassay COVID-19 antigen test, a rapid antigen test suitable for mass COVID-19 screening or for diagnosis of asymptomatic or symptomatic individuals. Read More
FDA releases new guidance for developers of COVID-19 products
February 23, 2021 -- The U.S. Food and Drug Administration (FDA) has released new guidance for developers of products for COVID-19 diagnostics, vaccines, and treatments, with a particular emphasis on addressing coronavirus variants. Read More
Roche files EUA for SARS-CoV-2 rapid antigen test
February 8, 2021 -- Roche has filed an emergency use authorization (EUA) with the U.S. Food and Drug Administration for its SARS-CoV-2 rapid antigen test designed for use by healthcare professionals in point-of-care settings. Read More
One year later, lab specialists reflect on life in the shadow of COVID-19
February 3, 2021 -- It all started with ominous reports at the end of 2019 about a highly contagious virus that had emerged in Wuhan, China, seemingly a world away. But a few months later, many aspects of life across the globe would be in shambles, and lab medicine professionals would find themselves at the center of the worst public health crisis in 100 years. Read More
Visby gets $12M to make flu/COVID-19 self-tests
February 3, 2021 -- Visby Medical has received $12.3 million in U.S. government funding to speed up the development of its rapid, single-use flu/COVID-19 polymerase chain reaction test for at-home use. Read More
Protein biosensors show promise for SARS-CoV-2 testing
February 1, 2021 -- Scientists have developed biosensors to detect SARS-CoV-2 proteins and antibodies in simulated nasal fluids and human sera, according to a study published in Nature on January 27. The approach promises to be less costly and time-consuming than current COVID-19 testing methods. Read More