Diagnosing some disorders in children present unique challenges. Now, companies are looking at using artificial intelligence to uncover subtle tools to help. We also look at a new report on diversity in the biotech industry, research into long COVID-19, and Food and Drug Administration site inspections. Finally, we look at a positive advisory committee review of a new treatment for a rare disease, and the risks that pricing can pose to a successful launch.
The FDA has granted approval to a digital tool that uses eye-tracking technology to assist with diagnosing autism in children as young as 16 months. EarliTec Diagnostics developed this tool which uses artificial intelligence to analyze eye movements in patients and then compares the data to various benchmarks. This is the second technological tool related to autism diagnosis to receive FDA approval. The first was Canvas Dx, developed by Cognoa, which received clearance last year.
A recent diversity and inclusion report from BIO, the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations, paints a useful, if incomplete, picture of the diversity of the biotech industry. The survey included responses from only 99 companies, but this at least gives a baseline for measuring the impact of diversity, equity and inclusion initiatives in the industry.
Long COVID is generally used to describe ailments that linger long after an initial COVID-19 infection subsides. Estimates of how many people are affected vary widely, with one of the highest estimates coming from the U.S. Centers for Disease Control and Prevention at one in five of those infected with COVID-19. Given the broad population of people infected, researchers are working hard to understand the cause and possible therapeutics.
Over the course of the pandemic, the FDA has struggled to keep up with site inspections because of travel restrictions and reallocating staff to pandemic response. A recent report looking at site inspection performance in fiscal year 2021 shows that the agency is continuing to struggle keeping up with the demand for inspections.
Bluebird Bio received a unanimous vote from the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee for its beti-cel drug which treats patients with beta thalassemia, a rare blood disease. A final FDA decision on approval is expected in August. The drug was approved in Europe in 2019 but was pulled from that market after the company was unable to reach an agreement on pricing with payers.