Imagia, Illumina partner to advance precision medicine
June 23, 2020 -- Healthcare artificial intelligence firm Imagia is partnering with Illumina on a project to further advance the development of precision medicine using genomic and health data.
FDA tells labs to remove faulty coronavirus antibody tests from stock
June 22, 2020 -- The U.S. Food and Drug Administration (FDA) has advised labs not to use antibody tests for the novel coronavirus that have been found to have low performance and to remove them from stock.
Diagnostics wanted for emerging infections, tomorrow's pandemics
June 19, 2020 -- While the severity of COVID-19 and its rapid spread was not something anyone anticipated prior to its manifestation in Wuhan, China, last year, the coming of a global pandemic had often been predicted.  Discuss
Real-world data project will help FDA assess COVID-19 diagnostics
June 19, 2020 -- The U.S. Food and Drug Administration (FDA) plans to use real-world data to evaluate and foster development of COVID-19 molecular and antibody tests through a new multistakeholder public-private partnership.
Immunexpress to develop sepsis test with BARDA grant
June 19, 2020 -- Molecular diagnostic company Immunexpress was awarded a grant up to $599,549 from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a test that will help triage COVID-19 patients at risk for sepsis.
FDA paves way for mass coronavirus screening of asymptomatic people
June 18, 2020 -- The U.S. Food and Drug Administration (FDA) has published guidance for diagnostics developers that it said will enable broad diagnostic testing of asymptomatic people and sample pooling during the COVID-19 pandemic.  Discuss
FDA issues warnings for misbranded COVID-19 antibody tests
June 18, 2020 -- The U.S. Food and Drug Administration (FDA) has issued warning letters to three companies for marketing "adulterated and misbranded" COVID-19 antibody tests, the first letters of their kind since the onset of the pandemic.
Google reports pathology AI helps predict survival in cancer patients
June 17, 2020 -- Google scientists reported proof-of-concept data for their artificial intelligence (AI) system in analyzing pathology images and predicting survival of cancer patients in PLOS One on June 17.  Discuss
FDA OKs FoundationOne companion test for high tumor mutational burden
June 17, 2020 -- The U.S. Food and Drug Administration (FDA) has approved Foundation Medicine's FoundationOne CDx for patients with solid tumors and high tumor mutational burden who are eligible to take the immunotherapy pembrolizumab (Keytruda).
Mount Sinai files COVID-19 quantitative serology test
June 17, 2020 -- Mount Sinai Health System has submitted a request for an emergency use authorization to the U.S. Food and Drug Administration covering a quantitative serology test for the novel coronavirus.