Diagnostic maker Cellex has announced plans to develop a rapid coronavirus infection test that people can fully perform at home, from sample collection to result—with 15-minute readings double-checked by a personal smartphone app. The company is partnering up with Gauss, a developer of machine vision-based healthcare programs, to help digitize the results of its upcoming COVID-19 antigen test. Cellex said it is currently working to validate its diagnostic, which has previously shown a false negative rate of about 10% while returning no false positive results, through clinical trials.
Meanwhile, the smartphone app from Gauss aims to provide step-by-step video instructions on how to self-collect a nasal swab sample and perform the test. After 15 minutes, the app prompts the user to scan the result using the smartphone’s camera, which reads the image and confirms whether it is positive or negative. “This AI-enabled COVID-19 antigen test for home use will make self-monitoring and isolation feasible, thereby playing a significant role in changing the trajectory of the COVID-19 pandemic in America and beyond,” said James Li, founder and CEO of Cellex, which previously received the FDA’s first emergency authorization for a rapid COVID-19 antibody blood test in April.
Trials ‘Unable to Bounce Back’ After COVID-19 Chaos
Clinical trial firm Phesi’s new report is some grim reading for the life science industry: Despite some forward motion over the summer, studies for new drugs are still suffering. Phesi, which offers trial solutions to life science companies, says its data “show clinical trial suspensions continue to rise as COVID-19 impact on development persists,” adding that costs are set to “spiral out of control” if companies fail to become data-driven by next year (a service it also offers). Others, such as biopharma analytics firm GlobalData, have been more positive, seeing upward trends in trials returning to normal. A new report out by Frost & Sullivan this month also saw green shoots of recovery for CROs.
But Phesi is still seeing major roadblocks. Its previous analysis in May found that of 300,000 global clinical trial sites, there had been a 38% increase in suspensions from the beginning of the year. Now, new analysis from this month indicates these suspensions peaked in early June and, after an initial drop, have risen again, with over 28,000 sites currently suspended.Sites did begin recruiting again in June 2020, rising to almost pre-pandemic levels, but while these new sites have appeared, many other investigator sites could go under forever.