FDA has approved Cepheid's point-of-care diagnostic test for COVID-19, Gilead secures orphan status for remdesivir, and more.
- FDA has approved Cepheid's diagnostic test for COVID-19, the disease caused by the new coronavirus. Cepheid's is the first FDA-approved point-of-care diagnostic test for the disease. The test can diagnose COVID-19 in 45 minutes, but it will most likely be used only in urgent situations within a hospital, ED, or to test health care workers (Modern Healthcare, 3/23; Herper/Facher, STAT News, 3/21).
- FDA is warning consumers to avoid at-home tests for COVID-19, saying the agency has not authorized any such tests to be administered by patients. FDA said it has started seeing "unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home," and that those tests come with serious health risks (Burton/Winkler, Wall Street Journal, 3/23).
- Gilead Sciences is pausing access to its experimental COVID-19 treatment remdesivir due to "overwhelming demand." Gilead said it will focus on meeting previously approved requests. The drug on Monday also received orphan drug status by FDA, meaning Gilead will receive a seven-year market exclusivity period. University Hospitals will conduct two clinical trials to see if the drug can act as a treatment for COVID-19 patients. One trial will focus on treating moderate COVID-19 patients, while the other will focus on more severe cases of the disease that may require ICU care (AmericaJR, 3/23; Herper, STAT News, 3/22; Joseph, Reuters, 3/23).
- Health officials in King County, Washington, have launched the greater Seattle Area Coronavirus Assessment Network (SCAN) to better track the spread of the new coronavirus throughout the county and understand the impact public health measures such as social distancing and school closures have had on the virus' spread. To do so, SCAN will deliver self-test coronavirus kits with nasal swabs to volunteers who will send DNA samples back to SCAN to be analyzed. Infrastructure and logistics for SCAN will be provided by Amazon Care, a medical system for Seattle-area Amazon workers (Doughton, Seattle Times, 3/23).
- Kinsa Health, a developer of smart thermometers, announced it is tracking the spread of the new coronavirus in real time using its thermometers, something it previously has done to predict how the flu will spread. According to Inder Singh, founder of Kinsa, the company's thermometer data "acts as an early warning system for illness spreading," and operates quicker than CDC's surveillance because the agency relies on reports from doctors' offices and hospitals (McNeil, New York Times, 3/18).
- Roche Holding AG on Monday announced that it has received FDA approval to test Actemra, its treatment for rheumatoid arthritis, on patients with severe pneumonia from COVID-19. Roche said it's starting a late-stage trial to test the effects of the drug on the disease (Mishra, Reuters, 3/23).
- University Hospitals has developed an app that providers can use to monitor patients remotely during the COVID-19 epidemic. The app, called Doctella, uses a finger sensor to check the oxygen saturation level and respiration rates of patients. University Hospitals plans to launch the app next week (Kilpatrick, Cleveland.com, 3/23).