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.
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.
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.