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-2

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.

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.

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.

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.

Myriad estimates there are more than 78,000 cases of prostate cancer and 40,000 cases of pancreatic cancer per year in Japan.

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.

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.

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.

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.

The ECRI Institute identified these issues as the biggest patient safety concerns in 2020. Can medtech help tackle them?

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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).

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.

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.