Dermtech Inc., of La Jolla, Calif., has had a busy couple of weeks, revealing late last month that its noninvasive melanoma detection test is available for use via telemedicine. Now, the company has unveiled first-quarter results that saw assay revenue of $0.8 million, a 238% increase from the first quarter of 2019.
LONDON – Lateral flow diagnostics specialist Mologic Ltd. has teamed up with Biosure Ltd., manufacturer of the only CE approved HIV home testing kit, to produce a COVID-19 antibody self-test. The companies are combining Mologic’s validated IgG antibody lateral flow strip with Biosure’s test kit, and say the product will be ready for mass production at the beginning of June.
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) has given the green light to Tokyo-based Fujirebio Inc.’s antigen test kit. Fumihito Takanashi, a spokesperson from the medical device evaluation division of the MHLW, told BioWorld that the approval came into effect May 14.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied DNA, Medalliance.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Archerdx, Bayer, Bluecross Blueshield of Tennessee, Caredx, Duality Technologies, Ekf Diagnostics, Integrated Computer Solutions, Lenovo, Lexent Bio, Progressive Care, Respiraworks, Senseonics, Transenterix, Tosoh Europe, Veracyte.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cardiologs, Exact Sciences, Icad, Pluristem Therapeutics, Tiziana Life Sciences.
LONDON – Geopolitical tensions over the issue of access to COVID-19 vaccines intensified this week, after the CEO of French pharmaceutical company Sanofi SA said the U.S. government would get first access to its product because it was first to fund the research.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Aim Immunotech, Cellphire, Enzychem, Immunic, Nordic Nanovector, Pharmazz, Restem, Sanofi, Scimount, Seattle Genetics, Takeda, Verona, Zealand.
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