Blood Test for Brain Injuries Took 20 Years to Reach Patients

Physicians at UPMC Presbyterian Hospital in Pittsburgh can now use a blood test to quickly assess adult patients with suspected traumatic brain injuries, helping them decide if a CT scan is necessary. The test measures levels of two proteins, GFAP and UCH-L1, in the bloodstream, offering objective data in emergency situations.

However, this advancement followed a 20-year journey from initial university research to clinical use, highlighting challenges within American innovation policy. The development of the test involved a complex process encompassing federal funding from the NIH and DOD, patents, startup creation (Banyan Biomarkers), venture capital, technology transfer, clinical trials, acquisition by Abbott, FDA review, and entrepreneurial risk-taking.

This path was also complicated by legal uncertainty surrounding patent eligibility for diagnostic inventions, stemming from court decisions interpreting Section 101 of the Patent Act. The story underscores the importance of strong intellectual property rights in facilitating collaboration between research organizations and manufacturers, enabling specialized contributions and accelerating the commercialization of scientific discoveries. Current debates over patent law, specifically the Patent Eligibility Restoration Act (PERA), should prioritize reducing obstacles to innovation and recognizing that delays have real costs for patients and the healthcare system.