Acetaminophen is the most common drug for pain and fever, and it is the most common cause of liver failure in the US. 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. Now, a new blood test can detect blood markers for liver injury from acetaminophen overdose in about 20 minutes.

The first rapid diagnostic test for acetaminophen toxicity has been developed by researchers at the University of Arkansas for Medical Sciences (UAMS, Little Rock, AR, USA). The test’s inventors have received a three-year USD 3.2 million grant from the National Institutes of Health (NIH) 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.

“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 UAMS’ Laura James, M.D., one of the test’s inventors who is optimistic about the assay’s prospects for FDA approval, given its past performance.

“I have been impressed that the assay provides a reliable yes/no answer as to whether acetaminophen is responsible for the liver injury,” said William M. Lee, M.D., a liver disease specialist at the University of Texas Southwestern Medical Center at Dallas, who is a co-investigator on the clinical trial and has been involved in prior testing of the assay. “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.”

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