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Share it Liquid biopsy developers feature heavily in the latest round of FDA breakthrough designations, with Natera, Inivata and Bluestar Genomics all securing the status for their blood-based cancer tests. Natera disclosed two breakthrough designations for its Signatera molecular residual disease (MRD) test. The designations provide a boost to Natera’s efforts to develop the circulating tumor DNA test through phase 3 trials as a companion diagnostic to two cancer medicines. Texas-based Natera framed the FDA designations, which bring the number of Signatera breakthrough statuses up to three, as a reflection of progress in its cancer biopharma business. The unit has signed $65 million in contracts over the past year. Natera is yet to win FDA approval but it performs the test as a CLIA-certified laboratory. ....
Loading video. VIDEO: Keck Graduate Institute (KGI) Assistant Professor and University of California, Berkeley Visiting Scientist Dr. Kiana Aran first introduced the CRISPR-Chip technology in 2019. Now just two years later, she has. view more Credit: Keck Graduate Institute (KGI) and Cardea Bio CLAREMONT, CA - Keck Graduate Institute (KGI) Assistant Professor and University of California, Berkeley Visiting Scientist Dr. Kiana Aran first introduced the CRISPR-Chip technology in 2019. Now just two years later, she has expanded on its application to develop CRISPR-SNP-Chip, which enables detection of single point mutations without amplification in Sickle Cell Disease and Amyotrophic lateral sclerosis (ALS). The field of CRISPR-based diagnostics is rapidly evolving due to CRISPR programmability and ease of use, Aran says. However, the majority of CRISPR-based diagnostics platforms are still relying on target amplifications or optical detections. The repr ....
Backed by millions in public and private cash, rapid Covid tests are coming to stores near you Scientists and lawmakers agree that over-the-counter Covid tests could allow desk workers to settle back into their cubicles and make it easier to reopen schools and travel. But even as entrepreneurs race their products to market, armed with millions of dollars in venture capital and government investment, the demand for Covid testing has waned. Manufacturing and bureaucratic delays have also kept rapid tests from hitting store shelves in large numbers, though the industry was energized by the Food and Drug Administration s greenlighting of two more over-the-counter tests Wednesday. ....
CDC and NIH launch community COVID-19 testing initiative The Centers for Disease Control and Prevention (CDC), in collaboration with the National Institutes of Health (NIH), has launched an innovative community health initiative called Say Yes! COVID Test starting in Pitt County, North Carolina, and coming soon to Chattanooga/Hamilton County Tennessee. As many as 160,000 residents across the two communities will have access to free, rapid antigen tests that they can administer themselves to use three times a week for one month. NIH will provide the tests (also called a home-test or at-home test) and evaluate the effectiveness of the initiative, which aims to determine if frequent self-administered COVID-19 testing helps residents reduce community transmission of SARS-CoV-2, the virus that causes COVID-19 disease. ....