Lab News
Promega seeks EUA for COVID-19 antibody detection test
August 11, 2020 -- Promega applied to the U.S. Food and Drug Administration for an emergency use authorization (EUA) for its new serological antibody test for COVID-19, Lumit Dx. The SARS-CoV-2 immunoassay is an IVD test that detects the presence of antibodies against SARS-CoV-2.
Hologic debuts pooling protocol for COVID-19 tests
August 11, 2020 -- Hologic has validated the use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and has also applied for an emergency use authorization to the U.S. Food and Drug Administration for pooled test processing.
Sophia launches AI-powered SARS-CoV-2 analysis algorithm
August 11, 2020 -- Sophia Genetics has released a SARS-CoV-2 genome analysis algorithm that uses artificial intelligence (AI) to synthesize viral strain, genetic response, and clinical management data.
Sysmex America inks distribution deal with Siemens
August 10, 2020 -- Sysmex America has secured a contract with Siemens Healthineers to distribute that company's Clinitek Novus automated urine chemistry analyzer in North America. The system features dry-pad urine chemistry technology and a cassette test format.
Illumina's Q2 revenue drops 25%
August 10, 2020 -- Illumina's revenue dropped 25% due to the impact of the COVID-19 pandemic on the company's business in the second quarter. The company's net income also dropped sharply.
FDA grants Vela EUA for SARS-CoV-2 test
August 10, 2020 -- The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Vela Diagnostics for the manual version of its ViroKey coronavirus polymerase chain reaction (PCR) test, which targets conserved regions of the viral genome.
FDA approves Guardant's liquid biopsy NGS test
August 7, 2020 -- The U.S. Food and Drug Administration (FDA) has approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) to identify patients with specific types of EGFR mutations in a form of metastatic non-small cell lung cancer.
New breast cancer test designed for use in developing regions
August 7, 2020 -- Scientists have created a point-of-care breast cancer diagnostic test called CytoPan that is designed for use in developing regions.
Biomarkers to determine COVID-19 odds: GW researchers
August 7, 2020 -- George Washington (GW) University researchers have found five biomarkers associated with higher odds of clinical deterioration and death in COVID-19 patients.
Veracyte touts Percepta clinical trial results
August 6, 2020 -- Veracyte is highlighting clinical trial results published August 3 in Chest that show its Percepta classifier can reduce the need for subsequent invasive procedures for lung cancer diagnosis by better classifying low-risk patients after inconclusive bronchoscopy.
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