Sekisui Diagnostics4 Hartwell Place Lexington, MA, USA 02421Latest from Sekisui DiagnosticsBlood ClotsRevenues from coagulation lab and POC tests near $4B in 2021By Bruce CarlsonHemostasis (coagulation) is a complex process in which multiple enzymes and proteins regulate blood flow and clot formation. Coagulation (clot formation), fibrinolysis (the breakup of blood clots), and platelet aggregation are a part of this process.February 15, 2022InfluenzaSekisui secures FDA clearance, CLIA waiver for rapid flu antigen testBy LabPulse.com staff writersUtilizing traditional lateral flow technology, the test kit is designed for qualitative detection of influenza type A and type B nucleoprotein antigens from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The company noted the importance of being able to rule flu in or out in the process of assessing patients for other respiratory infections during the COVID-19 pandemic.June 8, 2020Bacterial VaginosisUSPSTF: Pregnant women may not need vaginosis screeningBy Kate Madden YeeThe recommendation updates the task force's 2008 guideline with a further literature review but is not different, wrote a team led by USPSTF chair Dr. Douglas Owens of Stanford University. The group found that bacterial vaginosis screening just doesn't seem to offer an advantage for avoiding preterm delivery, which has been associated with the condition.April 7, 2020Health TopicsMolecular testing and COVID-19: Where are we now?By Justin SaeksCountries have been trying to apply the lessons learned in the regions that were hit first. China appears to have dramatically slowed the disease, and one of the key aspects of that effort has been large-scale diagnostic testing.Tests that received EUAs as of March 24March 25, 2020InfluenzaSekisui announces Acucy flu test clearanceBy LabPulse.com staff writersThe test is designed for use with the company's Acucy point-of-care reader, which Sekisui said can be used to test nasal and nasopharyngeal swabs onsite as well as in laboratory settings. Sekisui announced the clearance on October 8, following an FDA decision on December 17, 2018.October 8, 2019Product LaunchKalorama's notable product launches for clinical labs in Q1 2019By Bruce CarlsonIn the POC segment, one of the breakthrough approvals from the U.S. Food and Drug Administration (FDA) was for the Sangia total prostate-specific antigen (PSA) test by Opko Health (Woburn, MA) in January. The Sangia test is the first POC test that quantitatively measures total PSA in capillary whole blood, and it is approved for use with the digital rectal exam (DRE) to screen for prostate cancer in men 50 years and older. The test can be administered with a finger prick and results are generated in 12 minutes.April 24, 2019
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