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Dr. Nefertiti Brown, who is an attending physician in California, was tested for COVID-19 on March 18th after displaying symptoms of the virus.2020-04-07View More
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The new five-minute test is the second Abbott test to receive emergency use authorization by FDA for COVID-19 detection. Combined, Abbott expects to produce about 5 million tests a month.2020-04-07View More
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A U.S. government contract is expected to accelerate the development, validation, and FDA clearance of Cue Health's portable, molecular diagnostic test to detect SARS-CoV-22020-04-07View More
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Grail had a huge win in the liquid biopsy space this week. The Menlo Park, CA-based company said results of its Circulating Cell-Free Genome Atlas study show its technology can detect 50 cancer types across all stages with a very low false-positive rate.2020-04-07View More
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The Erlangen, Germany-based company said its Fast Track Diagnostics (FTD) SARS-COV-2 Assay is already being shipped in Europe for research use only.2020-04-07View More
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The Austin TX-based company was granted Emergency Use Authorization for the Aries SARS-CoV-2 Assay and the NxTAG CoV Extended Panel to help in the detection of the novel coronavirus.2020-04-07View More
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Bio-Rad Laboratories has developed an assay to detect the SARS-CoV-2 virus, cause of the COVID-19 pandemic, using its droplet digital PCR systems, and similar ddPCR tests have been shown in recent preliminary studies to reduce false negative results.2020-03-31View More
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Myriad estimates there are more than 78,000 cases of prostate cancer and 40,000 cases of pancreatic cancer per year in Japan.2020-03-31View More
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Rendu Biotechnology said on Monday that it has received emergency approval from China's National Medical Products Administration for a SARS-Cov-2 nucleic acid detection kit.2020-03-31View More
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Thermo Fisher Scientific said on Monday that it has priced an offering of €1.2 billion ($1.33 billion) worth of euro-denominated senior notes.2020-03-31View More
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Both CerTest Biotec and Becton Dickinson and Company have received a CE mark for the VIASURE SARS-CoV-2 Real-Time Polymerase Chain Reaction (PCR) Detection Kit adapted for the BD Max System.2020-03-30View More
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The Menlo Park, CA-based company has raised $15 million in a follow-on to its series A round and said it will use the proceeds to support the commercial expansion of its prenatal screening test and help with R&D efforts into a liquid biopsy product.2020-03-30View More
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The ECRI Institute identified these issues as the biggest patient safety concerns in 2020. Can medtech help tackle them?2020-03-30View More
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Pressed for time? Here's the medtech news you need most, in one minute or less.2020-03-30View More
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Thermo Fisher Scientific is the latest company to be granted Emergency Use Authorization for a diagnostic to detect the coronavirus (COVID-19).2020-03-30View More
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In addition to increasing production of its collection devices, BD worked with BioGX Inc. to request an FDA Emergency Use Authorization for a new COVID-19 diagnostic.2020-03-30View More
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Irvine, CA-based Oncocyte inherited the DetermaIO test when it acquired Insight Genetics earlier this year. The company said it has completed Clinical Laboratory Improvements Amendments (CLIA) validation for the test.2020-03-30View More
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FDA issued a letter to industry that includes steps the agency's Center for Devices and Radiological Health (CDRH) has taken to prioritize work that advances the nation¡¯s response during the Coronavirus (COVID-19) public health emergency.2020-03-30View More
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A new UK-based research consortium is betting that sequencing the virus that causes COVID-19 can provide policymakers with a clearer picture of the spread of the epidemic across the country as diagnostic testing remains limited.2020-03-30View More
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The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firm's NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens.2020-03-30View More
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