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Hologic Obtains CE Mark for Molecular Epstein-Barr, BK Virus Assays
2022-05-26
Hologic announced Wednesday it has obtained CE marking for its Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay, expanding its transplant pathogen monitoring menu on the automated, real-time PCR Panther Fusion system.
Weimi Bio-Tech's COVID-19 Antigen Rapid Test has obtained CE certification
2022-05-25
On May 19, the COVID-19 Antigen Rapid Test (colloidal gold method) independently developed by Guangzhou Weimi Bio-Tech Co., Ltd (“Weimi Bio-Tech”) successfully obtained the EU CE certificate.
Illumina Adds CDx Indication to European TruSight Oncology Test for NTRK Gene Fusion Detection
2022-05-25
Illumina said on Tuesday that it has added a companion diagnostic indication to its in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test.
Agilent Technologies Fiscal Q2 Revenues Rise 5 Percent
2022-05-25
Agilent Technologies reported after the close of the market on Tuesday that its fiscal second quarter revenues rose 5 percent year over year.
New Horizon Health and Prenetics reach a partnership
2022-05-24
On May 23, New Horizon Health (6606.HK) and Prenetics Group Limited (NASDAQ: PRE, Prenetics for short) jointly announced a strategic cooperation to promote the listing of cancer early screening product ColoClear in Hong Kong and "going overseas" to Southeast Asia.
Google hires former FDA digital health officer to global strategy post
2022-05-24
Google confirmed the hire and said Bakul Patel will report to Linda Peters, vice president of quality, regulatory and safety at Google Health.
Luminex Obtains CE Marking for MDx Panel to Detect Flu A/B, RSV, COVID-19
2022-05-24
DiaSorin's Luminex on Friday announced it has obtained CE marking for its Aries Flu A/B & RSV+SARS-CoV-2 Assay, a multiplex molecular panel that detects four common respiratory viruses and their underlying respiratory infections.
Nanomix Nabs CE Mark for Point-of-Care COVID-19 Antigen Test
2022-05-23
Nanomix said on Friday that it has received the CE mark for its eLab COVID-19 antigen test which provides qualitative results in 15 minutes from an anterior nasal swab.
FDA Grants EUAs for LabCorp Respiratory Panel, Nexus Medical COVID-19 Test
2022-05-23
The US Food and Drug Administration this week granted separate Emergency Use Authorizations for a respiratory panel RT-PCR test from Laboratory Corporation of America and a COVID-19 RT-PCR test from Nexus Medical Labs.
Several Chinese IVD companies have already developed monkeypox detection reagents!
2022-05-23
The WHO office in Congo (DRC) released a message on May 20, local time, saying that more than 1,200 people suspected of being infected with monkeypox virus. Virus spread across 18 provinces across the country and caused 58 people died.
6 COVID-19 test kits obtained CE mark
2022-05-20
6 COVID-19 test kits obtained CE mark
Cepheid Gets CE Mark for Updated Rapid COVID MDx Test
2022-05-20
Cepheid announced on Thursday that it has obtained the CE mark for a rapid molecular test to detect the SARS-CoV-2 virus. The new test will begin shipping this month.
LumiraDx Obtains CE Mark for Five-Minute SARS-CoV-2 Antigen Test
2022-05-20
LumiraDx on Thursday announced it has obtained CE marking for its five-minute SARS-CoV-2 Ag Ultra Test.
The first Chinese oral drug report for SARS-CoV-2 announced
2022-05-19
On May 18, the treatment report of the first Chinese produced SARS-CoV-2 oral drug was announced.
FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests
2022-05-19
The Food and Drug Administration published a Class I recall report for two COVID-19 testing products that covers the removal of more than 51,000 unauthorized coronaviurs tests from the U.S. market.
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