Abbott’s i-STAT Alinity System
Abbott recently received an $11.2 million contract from the U.S. Department of Defense (DOD) to develop a portable blood assay that can detect mild traumatic brain injury (TBI). The new contract builds on a previous agreement, inked in 2014, to develop the technology.
Assessing mild TBI with a blood test could be tremendously useful for the military. More than 360,000 service members have suffered a TBI since 2000, and diagnosing them has often been inexact, according to the DOD.
“Currently, service members are evaluated for a brain injury by assessing the incident and symptoms,” said to Kara Schmid, project manager for the Neurotrauma and Psychological Health Project Management Office at the U.S. Army Medical Materiel Development Activity, in an email. “This technique requires service members to remember and accurately report the encounter, which can have problems. For example, a concussed individual may not actually know they were hit on the head, or they may decide to keep the incident to themselves. The development of a laboratory assay for TBI on a point-of-care device will provide an objective measure of brain injury from a blood sample.”
Abbott has been tasked with developing a small, portable assay that can be easily carried by one person and produce results in less than 15 minutes. To meet these requirements, the company is building on its portable i-STAT technology, which is currently being used in hospitals to support cardiovascular and prenatal care and provide other simple blood tests. The new contract will allow Abbott to complete work on the TBI test and ultimately deploy it.
“With the recent contract from the DoD, Abbott is in the final phase of development,” said neurologist Beth McQuiston, medical director for Diagnostics at Abbott, in an email. “Essentially, this means that we’re refining and optimizing the technical aspects of the tests for clinical use.”
Abbott is currently validating two promising concussion biomarkers — UCH-L1 and GFAP. The hope is that two or more markers will provide more precise diagnoses.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
“The Abbott concussion tests are being designed to measure these specific proteins that are released from the brain when it’s been injured during a concussion,” said McQuiston. “If these proteins are present at a certain level, it’ll serve as a warning bell that further evaluation is needed.”
When completed, the assay will be deployed in combat units, forward field hospitals, base hospitals, and other settings. In addition, the device could have a tremendous impact on civilian care for motor vehicle accidents, sports injuries and other traumatic events.
“Many of our TBI product development efforts are translatable to the civilian network,” said Schmid. “Not only will this assay provide information to help military clinicians, the ultimate goal of the laboratory assay for TBI is to provide actionable information in all scenarios involving TBI.”
