Biomarkers are gaining an increasingly important role in the diagnosis and prognosis for neurological diseases, particularly traumatic brain injury (TBI). Yet major challenges remain in fully integrating candidate biomarkers into clinical practice, and laboratorians have an important role to play in addressing many of these issues.

In a session at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo, Biomarkers of the Brain: Past Failures and Future Promise, Frederick Strathmann, PhD, of the University of Utah and ARUP Laboratories in Salt Lake City, and Leslie Shaw, PhD, of the University of Pennsylvania, provide insight into current gaps in clinical offerings and identify areas where laboratory intervention and support are most needed.

“It is an exciting time in biomarker discovery,” said Strathmann, who is moderating the session. “New tools and techniques are becoming available continuously and software programs capable of multidimensional analyses are becoming more usable by and approachable to non-experts.” Among the most exciting blood-based biomarkers in the area of TBI, he said, are glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1).

Even with the promise of GFAP and UCH-L1, a lack of reproducible research and validation data in research methods is hampering advancement of candidate biomarkers, according to Strathmann. Another issue holding back clinical use of neurological markers is studies not taking into consideration known limitations in the clinical laboratory environment, most notably sample stability needs. 

There are also numerous unanswered questions, he said. “Will we need new instruments or technologies to usher in these discoveries? Will they require mass spectrometry? Is there an opportunity to collaborate? Answering these questions is key to ensuring a successful transition from research into the clinical lab.”

Because research in this area is so active, laboratorians should be aware of how the science is progressing, Strathmann recommended.

His session will explore: the clinical tools currently used in diagnosing and treating neurological diseases; the role of certain cell types in neurological disease pathology; shortcomings of past research approaches that have inhibited translation of research findings into clinical practice; and comparison of how biomarkers for diagnosis versus biomarkers for prognosis are classified.