Leo O'ConnorBusiness InsightsWeek in Review: Quest’s long COVID testing panels | DiaSorin’s 510(k) clearance | BioMérieux's strategic investmentThis week, Quest Diagnostics introduced two panels for consumers that offer information about lingering health issues associated with previous COVID-19 virus infections.March 23, 2023Financial ResultsLumiraDx Q4 revenues drop 65% on lower COVID-19 testingThe firm recorded an accounting impairment in Q4 for excess manufacturing and inventory related to the scale-up during peak COVID-19 testing demand and the decision to pause commercialization of its Amira COVID-19 test.March 21, 2023Emergency Use AuthorizationCue Health receives FDA emergency use authorization for molecular mpox testThe test demonstrated high accuracy in clinical trials, achieving 100% concordance with the Center for Disease Control and Prevention’s (CDC's) mpox test on the samples tested, Cue Health said.March 20, 2023510(k)FDA grants 510(k) clearance to DiaSorin for COVID-19 and flu A/B assayThe test detects and differentiates influenza A, influenza B, and SARS-CoV-2 viruses to help ensure physicians can recommend the most appropriate treatment for each patient.March 20, 2023Financial ResultsCue Health Q4 revenues decline 24% as firm expands, diversifies POC test menuThe company’s revenues have come predominantly from its COVID-19 testing product, but it is "executing well" on its strategy of expanding the test menu, CEO Ayub Khattak said.March 16, 2023Mergers & AcquisitionsChembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisitionChembio “faces ongoing operational and financial challenges” if it remains an independent company, its CEO wrote in a letter to stockholders.March 15, 2023Regulatory ApprovalFDA reissues EUA for Janssen COVID-19 vaccine, includes warning about risks of myocarditis, pericarditisSpecifically, the warning states that reports of adverse events after use of the vaccine under emergency use authorization (EUA) suggest increased risks of myocarditis and pericarditis, particularly from zero through seven days following vaccination.March 14, 2023Business InsightsWeek in Review: QuidelOrtho de novo authorization | Veracyte growth plans | Abbott concussion test clearanceThe FDA granted clearance to Abbott for the first commercially available laboratory test to detect concussion and a de novo request allowing QuidelOrtho to market its Sofia 2 SARS Antigen+ FIA test for use by prescription only.March 9, 2023Financial ResultsVeracyte sees revenue growth in oncology classifiers, new genomic products, global expansionAt a time when companies who have relied heavily on COVID-19 testing for revenues over the past few years are suffering from year-over-year declines in sales, the genomic oncology testing firm recently announced a 19% year-over-year jump in Q4 revenues.March 7, 2023Financial ResultsQuanterix Q4 revenues drop 15% but match analysts’ expectationsFor full-year 2022, total revenue was $105.5 million, a decline of 5% compared with 2021 revenue that included $5.2 million in National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) grant money.March 6, 2023Page 1 of 12Next PageTop StoriesBusiness InsightsU.S. IVD market reaches $53 billionAccording to Kalorama Information, the U.S. IVD market is projected to grow at a 2.4% average annual rate through 2027.SequencingRNA-seq analysis links protein to spread of pancreatic cancer, reveals potential drug targetCOVID-19Rapid nirmatrelvir treatment in study reduced long-COVID riskGenetic DisordersBionano announces study findings for optical genome mapping of rare reproductive system disorderInfectiousQuest Diagnostics offers suite of services for transplant patients and living donors
