Researchers in Spain have evaluated a minimally invasive test based on dried blood spot samples for hepatitis C RNA detection and genotyping.
The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.
Recently, the QuanNUA mass spectrometry system independently developed and manufactured by Intelligene Biosystems (Qingdao) Co., Ltd., the strategic partner of Bioperfectus Technologies, has successfully passed the inspection of Science and Technology Research Center of China Customs.
The independently developed "COVID-19 antigen detection kit SARS-COV-2 Nucleocapsid (N) Antigen Rapid Detection Kit (Colloidal gold method)" by Synthgene Medical Technology was approved by the UK 5-year CTDA certification.
On December 26, Hangzhou Biotest Biotech announced that the COVID-19 antigen home self-test test kit produced by Advin, has passed laboratory verification and clinical research evaluation and has now obtained the EUA from the US Food and Drug Administration.
The US Food and Drug Administration said on Thursday it has issued Emergency Use Authorizations to two over-the-counter, at-home antigen tests for detecting the SARS-CoV-2 virus.
The US Food and Drug Administration this week granted Emergency Use Authorization for OnsiteGene's Hi-Sense COVID-19 Molecular Testing Kit 1.0.
Chinese cancer diagnostics firm SeekIn said Monday that it has received the CE mark for its PanCanSeek Cancer Mutation Detection Kit and now intends to market the test in the European Union and other regions that recognize the designation.
Recently, Shenzhen Superbio Technology Co., Ltd. Fentanyl Drug Abuse Detection Kit (fluorescence chromatography method) has obtained 510 (k) pre-market notification, which is the world's first POCT product approved by the US FDA for the detection of fentanyl by fluorescence method.
The American College of Medical Genetics and Genomics strongly recommends noninvasive prenatal screening (NIPS) over other screening approaches for detecting common fetal trisomies for all pregnant patients, according to new practice guidelines published on Friday.
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