| |DECEMBER 20239Babson Diagnostics, a science-first health care technology business, announced that a key component of its BetterWay Blood Testing ecosystem has received FDA 510(k) clearance. These regulatory approvals open the way for Babson to launch BetterWay, the first-of-its-kind blood testing service, next year.BetterWay will reimagine the entire blood testing process, using only a pea-sized amount of blood collected from a fingertip and delivering results equivalent to traditional blood testing methods. The BetterWay service will enable blood testing by non-phlebotomists in convenient locations without sacrificing quality, accuracy, or the types of tests that are possible, as per pharmabiz"BetterWay is the blood testing service that consumers and health care professionals have been waiting for," said David Stein, chief executive officer of Babson Diagnostics. "Blood testing has remained largely unchanged over the past 70 years, yet it is a critical component of the care journey. BetterWay will help address the ongoing shortage of health care professionals as well as the increasing need to expand access and reduce health care costs. Our mission is to deliver a better experience at convenient locations, with easy-to-understand, medically accurate results trusted by clinicians."BetterWay blood testing for primary care and family medicine was painstakingly created by Babson to assist yearly checkups, chronic condition management, and screenings. The launch menu is expected to include the most frequently ordered blood tests and to make use of current CPT codes to facilitate clinician-directed prescriptions and payer processing.The FDA approval is also a significant milestone in Babson and BD's long-term strategic cooperation. Since 2016, the Babson team has been collaborating with BD on the development of BD MiniDraw. BD will be a primary supplier to Babson with BD MiniDraw, and Babson will be a distributor for BD. POThe U.S Food and Drug Administration (FDA) approved two gene therapies for sickle cell disease, including the first treatment in the country based on the Nobel Prize-winning CRISPR gene editing technique.Casgevy, developed by partners Vertex Pharmaceuticals and CRISPR Therapeutics, and bluebird bio's Lyfgenia were approved for people aged 12 years and older. CRISPR, discovered by Jennifer Doudna and CRISPR Therapeutics co-founder Emmanuelle Charpentier, uses molecular "scissors" to trim faulty parts of genes that can then be disabled or replaced with new strands of normal DNA, as per economic times.Bluebird's gene therapy works by inserting changed genes into the body via crippled viruses. Sickle cell disease is a severe, genetic blood ailment in which the body produces faulty, sickle-shaped hemoglobin, affecting red blood cells' ability to transport oxygen to the body's tissues.The condition, which can be severe and lead to death, affects an estimated 100,000 persons in the United States, the majority of whom are African-American."Today's actions follow rigorous evaluations of the scientific and clinical data needed to support approval, reflecting the FDA's commitment to facilitating development of safe and effective treatments for conditions with severe impacts on human health," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.Sickle cells tend to clump together and can clog small blood arteries, resulting in excruciating agony. They can also cause strokes and organ failure. Both medicines helped lessen painful episodes in patients with the illness in separate clinical studies, with 29 of 31 patients receiving Casgevy and 28 of 32 patients receiving Lyfgenia showing improvement. POBABSON DIAGNOSTICS SECURES US FDA NOD FOR BLOOD TESTING SERVICEUS FDA NODS TWO GENE THERAPIES FOR SICKLE CELL DISEASETOP STORIES
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