Qiagen plans FDA resubmission of coronavirus rapid antigen test
January 21, 2021 -- Qiagen is planning a first-quarter resubmission of its QIAreach rapid antigen test to the U.S. Food and Drug Administration (FDA). In separate news, the company said that its molecular diagnostics are effective for detection of the various known strains of the coronavirus.
Eurofins debuts new SARS-CoV-2 variant assay
January 15, 2021 -- Eurofins has launched a new SARS-CoV-2 assay and increased its capacity to detect and monitor new variants of the novel coronavirus.
FDA clears PerkinElmer coronavirus test for asymptomatic use
January 14, 2021 -- PerkinElmer's New Coronavirus Nucleic Acid Detection kit has received an emergency use authorization from the U.S. Food and Drug Administration (FDA) for use in testing people who do not have symptoms of infection and where there is no other reason to suspect a positive result.
MicroRNA blood test identifies severe malaria in children
January 13, 2021 -- A blood test for microRNAs shows promise for identifying children with severe forms of malaria and treating them accordingly, according to a new study published in Emerging Infectious Diseases, a journal of the U.S. Centers for Disease Control and Prevention.
BD sees Q1 revenues up 26% as COVID-19 testing drives sales
January 13, 2021 -- Becton Dickinson (BD) is projecting revenues for its fiscal first quarter to grow 26% as sales of COVID-19 testing products hit $865 million -- contributing 20 percentage points to revenue growth for the quarter.
COVID-19 pandemic accelerates adoption of diagnostic testing at point of care
January 11, 2021 -- Out of a very bad year where the COVID-19 pandemic brought the world to its knees has come some good, investors say. Point-of-care diagnostics tests are flourishing, according to panelists at the Biotech Showcase investor conference, held online from January 11-15.  Discuss
Abbott wins FDA nod for blood test to diagnose concussion
January 11, 2021 -- Abbott has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a rapid blood test to assist with the diagnosis of concussions and other mild traumatic brain injuries.
Grail to collaborate with top companies for MRD detection
January 11, 2021 -- Cancer diagnostics startup Grail has announced collaborations with Amgen, AstraZeneca, and Bristol Myers Squibb to evaluate the ability of Grail's methylation-based platform to detect minimal residual disease (MRD).
FDA warns labs that SARS-CoV-2 variant could cause false-negative test results
January 8, 2021 -- The U.S. Food and Drug Administration (FDA) has sent an alert to clinical laboratory staff and healthcare providers regarding the potential effect of SARS-CoV-2 viral mutations causing false-negative results on diagnostic tests.  Discuss
GeneIQ debuts a SARS-CoV-2, RSV, influenza A/B test
January 6, 2021 -- Molecular diagnostics lab GeneIQ has launched a polymerase chain reaction (PCR) test that can detect SARS-CoV-2, influenza A and B viruses, and respiratory syncytial virus (RSV).