Latest Headlines

31. Cerus Corporation Announces FDA Approval For INTERCEPT Blood System For Plasma With Alternate Plastic Disposable Kits 5/4/2020

    Cerus Corporation announced today FDA regulatory approval for manufacture of INTERCEPT plasma with a new, alternative plastic disposable kit

32. AVROBIO To Collaborate With Saladax Biomedical On New High-Speed Diagnostic Assay Used With Busulfan Conditioning To Enable Widespread Commercialization Of AVROBIO’s Proprietary Platform Globally 5/4/2020

    AVROBIO, Inc., a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced a new development and commercialization agreement with Saladax Biomedical, Inc. (Saladax), a leading diagnostics provider focused on developing blood tests for personalized dosing, to develop and validate a fully automated nanoparticle immunoassay kit designed to simplify and streamline therapeutic drug monitoring (TDM) for patients treated with the conditioning agent busulfan

33. DNA Genotek’s ORAcollect®·RNA Kit Included In EUA Granted To Biocerna SARS-CoV-2 Test 5/4/2020

    DNA Genotek Inc., a leading provider of sample collection kits and end-to-end services and a wholly-owned subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), announced today that its ORAcollect®·RNA kit (OR-100) was included as the collection device for anterior nares (nasal) samples under a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to Biocerna LLC for its PCR-based SARS-CoV-2 assay

34. Insight Into FDA's Revised Policy On Antibody Tests: Prioritizing Access And Accuracy 5/4/2020

    As we at the FDA have said before, every step we have taken in our approach to COVID-19 testing has been a careful balancing of risks and benefits – all done to anticipate and meet continuing and evolving public health needs as we combat this virus. That's why today the FDA issued an update to a policy from March 16, 2020 on antibody tests for COVID-19

35. AACC Endorses Verified Innovative Testing In American Laboratories Act 5/1/2020

    AACC endorsed the Verified Innovative Testing in American Laboratories (VITAL) Act, which would clarify the law around laboratory-develop tests (LDT) and definitively locate LDTs oversight solely within CLIA administered by the Centers for Medicare and Medicaid Services (CMS)

36. Hologic To Introduce Its Second High-Throughput Molecular Assay For The Novel Coronavirus (SARS-CoV-2) 4/29/2020

    Hologic, Inc. announced today that it plans to launch a new Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its market-leading Panther system

37. UAE Labs Get World's First Connected Management System To Accelerate COVID-19 Testing 4/29/2020

    InterSystems, a global leader in healthcare information systems and technology solutions, has signed an agreement with Pure Health, the largest laboratory operator in the GCC, to deploy InterSystems TrakCare Lab Enterprise (TCLE) system, the first and only laboratory business management solution, to support the UAE’s testing initiatives for COVID-19

38. LabVantage Solutions Announces New Purpose-Built Biobanking LIMS Accelerator For Managing COVID-19 Testing 4/28/2020

    LabVantage Solutions, Inc., the leading provider of laboratory informatics solutions and services including purpose-built LIMS that allow labs to go live faster and at a lower total cost, today announced the availability of its new purpose-built COVID-19 LIMS solution

39. Todos Medical Announces Positive Data For Serology Point-Of-Care Fingerprick Antibody Test Kits 4/28/2020

    Todos Medical Ltd. (OTCQB: TOMDF), a commercial in vitro diagnostics company focused on the development of blood tests for the early detection of cancer and neurodegenerative disorders, as well as point-of-care and lab-based tests for novel coronavirus (COVID-19 or COVID), today announced positive data for its Colloidal Gold point-of-care (POC) 2 to 10 minute fingerprick blood antibody test kits from a study of 71 patients with suspected COVID-19 infection (30 COVID PCR-Positive and 41 COVID PCR-Negative) admitted to the hospital

40. Biocept Announces CE-IVD Mark And Availability Of Its Target Selector™ EGFR Molecular Assay Kit In Europe 4/28/2020

    Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the award of CE (Conformité Européene)-IVD Mark for its Target Selector™ molecular assay EGFR Kit