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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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FDA announced that the agency will temporarily postpone all domestic routine surveillance facility inspections, those conducted every few years based on a risk analysis.2020-03-30View More
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On March 5, 2020, Amicus Therapeutics announced the official opening of its new Global Research and Gene Therapy Center of Excellence in Philadelphia, PA, to advance its portfolio of rare disease gene therapy programs.2020-03-30View More
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A new test being developed by Austin, TX-based Astrotech could detect coronavirus (COVID-19) and other lung diseases from the metabolites found in a person¡¯s breath.2020-03-30View More
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