LITTLE ROCK —The first rapid diagnostic test for acetaminophen toxicity has cleared a major hurdle on its long road to the marketplace from the University of Arkansas for Medical Sciences (UAMS).
The test’s inventors, UAMS’ Laura James, M.D., Jack Hinson, Ph.D., and Dean Roberts, Ph.D., received a three-year, $3.2 million National Institutes of Health (NIH) Small Business Technology Transfer (STTR) grant to conduct the final phase of study before seeking Food and Drug Administration (FDA) approval of the blood test.
The grant will include the final development of the new laboratory test AcetaSTAT, a rapid assay to diagnose acetaminophen liver injury, and a clinical trial involving multiple centers to evaluate the test’s performance.
The new blood test can detect blood markers for liver injury from acetaminophen overdose in about 20 minutes. Acetaminophen is the most common drug for pain and fever, and it is the most common cause of liver failure in the United States.
“It has been a long journey, but it has been fun and exciting because we’re moving toward a big contribution in health care,” said James, who founded her company, Acetaminophen Toxicity Diagnostics (ATD) LLC, in 2006 with Roberts and Hinson. James also serves as the director of the UAMS Translational Research Institute.
ATD developed the test in conjunction with UAMS and Arkansas Children’s.
Physicians have no FDA-approved test to confirm the diagnosis of acetaminophen liver injury. They must rely on patient history and nonspecific tests of liver injury when evaluating patients with liver injury due to acetaminophen overdose.
William M. Lee, M.D., a liver disease specialist at the University of Texas Southwestern Medical Center at Dallas, is a co-investigator on the clinical trial and has been involved in prior testing of the assay. James also credits him for giving her the idea to pursue a rapid, point-of-care test.
“I have been impressed that the assay provides a reliable yes/no answer as to whether acetaminophen is responsible for the liver injury,” Lee said. “I look forward to seeing AcetaSTAT being available in any Emergency Department worldwide. Having the test will ensure that more patients receive the right diagnosis and appropriate treatment.”
James is optimistic about the assay’s prospects for FDA approval, given its past performance. She has assembled a strong, interdisciplinary team to conduct the multisite clinical trial. The team members include (in alphabetical order):
- David Baker, CEO of ATD
- Hans Boehringer, Ph.D., vice president, Technology Development, DCN Diagnostics; consultant
- Ruofei Du, Ph.D., UAMS Department of Biostatistics; co-investigator
- Maryam Garza, Ph.D., College of Medicine Department of Biomedical Informatics; co-investigator
- Hinson, chief scientific officer; co-investigator
- Brendan O’Farrell, Ph.D., president, DCN Diagnostics; consultant
- Jeannette Lee, Ph.D., professor, UAMS Department of Biostatistics; co-investigator
- Fred Prior, Ph.D., distinguished professor and chair, College of Medicine Department of Biomedical Informatics; co-investigator
- Roberts, director of Research and Development; co-investigator
Jessica Snowden, M.D., associate professor and chief, Division of Pediatric Infectious Disease, College of Medicine Department of Pediatrics; and co-leader of the NIH-funded IDeA (Institutional Development Awards Program) States Pediatric Clinical Trials Network Data Coordinating and Operations Center; co-investigator