CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
FDA clears blood test for concussion assessment
April 2023—Abbott has received FDA clearance for its Alinity i TBI laboratory test for traumatic brain injury. The test provides a result in 18 minutes to help clinicians assess concussion and triage patients.
The Alinity i TBI test measures complementary biomarkers in blood plasma and serum—ubiquitin C-terminal hydrolase L1 (UCH-L1) and glial fibrillary acidic protein (GFAP)—that, in elevated concentrations, are tightly correlated to brain injury. Abbott reports that it provides test results with 96.7 percent sensitivity and 99.4 percent negative predictive value.
The test is for use as an aid in evaluating patients, age 18 or older, who present with suspected mild traumatic brain injury (Glasgow Coma Scale score 13–15) within 12 hours of injury, to assist in determining the need for a CT scan of the head.
The test previously received European Union clearance and has been available in markets outside the United States since 2021. Abbott’s i-Stat TBI Plasma test was cleared in 2021.
Roche, Lilly to collaborate for early Alzheimer’s disease diagnosis
Roche has entered into a collaboration with Eli Lilly and Company to support the development of Roche’s Elecsys Amyloid Plasma Panel. The FDA granted the panel breakthrough device designation in July 2022.
If approved, Roche says, the panel test would be an additional tool to identify low likelihood of amyloid pathology in patients with symptoms of Alzheimer’s disease and to determine whether they should proceed to further evaluation and testing that may confirm a diagnosis.
The panel measures phosphorylated tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma.
FDA clears high-throughput test for infectious vaginitis
BD received 510(k) clearance from the FDA for its BD Vaginal Panel on the BD Cor system.
The BD Vaginal Panel is a microbiome-based PCR assay that uses a single swab and test to simultaneously detect organisms associated with bacterial vaginosis, vulvovaginal candidiasis, and Trichomonas vaginalis, and it reports a clear positive or negative result for each condition separately. The 510(k)-cleared BD Vaginal Panel on the BD Cor system is the first high-throughput version of the test. The panel was launched in 2016 for use on the BD Max system.
Urging legislative solutions to pathologist shortage
In a March 20 letter, CAP president Emily Volk, MD, listed the steps Congress should take to reduce the shortage of pathologists.
A February hearing of the Senate Committee on Health, Education, Labor and Pensions on health care workforce shortages prompted committee chair Sen. Bernie Sanders (I-Vt.) and ranking member Sen. Bill Cassidy, MD (R-La)., to request information on the drivers of the workforce shortage and the remedies.
The primary drivers of the pathologist workforce shortage seem to be, Dr. Volk said, a lack of Medicare-supported GME positions, a demand for pathologists that is far exceeding the supply of new pathologists, the J-1 visa home country requirement, the lack of incentives to practice in rural and underserved areas, and state and local governments not providing the funding needed for resources for forensic pathologists.