Leo O'Connor

Sep 17, 2024 | labpulse.com | Nick Paul Taylor |Elissa Wolfson |Leo O'Connor

On the heels of monkeypox, avian or bird flu has become a hot focus of the U.S. Centers for Disease Control and Prevention (CDC)'s new contracts with a handful of commercial reference laboratories in the U.S. Utah-based ARUP Laboratories announced on September 13 its selection as a partner in the development of an avian influenza A (H5N1) test. Tennessee-based Aegis Sciences, Boston-based Ginkgo Bioworks, Labcorp, and Quest Diagnostics were also named.

Sep 16, 2024 | labpulse.com | Leo O'Connor |Bruce Carlson

Lexington, MA-based T2 Biosystems has received clearance from the U.S. Food and Drug Administration (FDA) to market its T2Candida Panel blood test for pediatric patients. The test works through a combination of DNA amplification and magnetic resonance imaging on T2's benchtop multiplex instrument. The T2Candida Panel is designed to detect sepsis-causing Candida species, including C. albicans, C. tropicalis, C. parapsilosis, C. krusei, and C.

Aug 29, 2024 | labpulse.com | Leo O'Connor |Bruce Carlson

Qiagen has expanded an agreement with AstraZeneca to develop a real-time polymerase chain reaction (RT-PCR)-based test panels for clinical molecular diagnostic testing in chronic disease investigational drug selection. Using its QIAstat-Dx platform, Qiagen plans to develop and validate a genotyping assay as a companion diagnostic (CDx) test for AstraZeneca's future genomically targeted medicines, Qiagen said.

Jul 23, 2024 | labpulse.com | Nick Paul Taylor |Elissa Wolfson |Leo O'Connor

Diagnostics firm Alveo Technologies announced that it has developed a rapid, point-of-need diagnostic for avian influenza that can detect the H5N1 variant based on sequences published from recent human infections in Colorado and those found in infected cattle. In a statement, Alveo said that the Flockscreen LAMP Avian Influenza Molecular Test can accurately detect the presence of the virus in both cloacal and oropharyngeal samples from poultry.

Jun 27, 2024 | labpulse.com | Matt Limb |Nick Paul Taylor |Elissa Wolfson |Leo O'Connor

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document intended to assist medical product sponsors with improving enrollment of clinical study participants through Diversity Action Plans. This draft guidance describes the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, as well as the timing and process for submitting Diversity Action Plans to the FDA.