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ABCDx Prepping Point-of-Care TBI Test for Launch in Late 2018, Early 2019

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NEW YORK (360Dx) – Researchers affiliated with the University of Geneva and Barcelona's Vall d’Hebron Research Institute have launched a diagnostics firm focused on biomarkers for brain conditions.

Named ABCDx, the Geneva-based company is developing tests for assessing mild traumatic brain injury (mTBI), distinguishing between ischemic and hemorrhagic stroke, and identification of stroke patients at risk of developing infections. It aims to launch in Europe a point-of-care test for diagnosing mTBI at the end of this year or beginning of 2019, said Jean-Charles Sanchez, a cofounder and head of the translational biomarker group at the University of Geneva.

He said the company was registered in 2014 but did not begin serious research and product development until 2016.

The mTBI test measures levels of the protein H-FABP in blood samples from patients who are suspected of having suffered a concussion with the aim of ruling out patients who will have negative findings on a CT scan, allowing them to avoid unnecessary scans. In a study published this week in PLOS One, H-FABP distinguished between CT-negative and CT-positive patients with a specificity of 33 percent at a sensitivity of 100 percent, meaning the test could rule out one-third of patients suspected of having mTBI as not needing a CT scan without missing any true mTBI cases.

The company has packaged the test as a point-of-care device called TBIcheck that measures H-FABP levels in a drop of blood and returns a negative or positive result in 10 minutes.

Sanchez said the point-of-care test could be useful for small clinics where CT scans are not readily available. In the case of a negative result, the patient can go home without additional follow-up, while in the case of a positive result, a clinician can send the patient to a larger facility for a scan. He added that the company has also drawn interest from military institutions interested in the device for assessing whether soldiers in the field have suffered concussions.

ABDCx plans in the next few months to launch a pair of prospective studies, one in Spain and one in Switzerland, to validate the test's performance, Sanchez said.

The H-FABP test is the company's first-generation mTBI diagnostic, but Sanchez said it is also developing a second-generation test measuring multiple protein markers.

In the PLOS One paper, Sanchez and his colleagues measured levels of 13 proteins in suspected mTBI patients undergoing a CT scan and three different European hospitals. Using an initial cohort of 132 patients, 21 of whom were positive for mTBI on their CT scan, the researchers evaluated the ability of the markers individually and in panels to distinguish between CT-negative and -positive patients. They then used a second cohort of 109 patients, 17 of whom were CT positive, to validate the markers and panels. As noted, H-FABP performed with a specificity of 33 percent at 100 percent sensitivity, while a panel combining H-FABP with the proteins GFAP and IL-1) performed with a specificity of 52 percent at 100 percent specificity, meaning that it could identify roughly half of patients who did not need a CT scan without missing any CT-positives.

Sanchez noted that GFAP is also (along with the protein UCH-L1) a marker in Banyan Biomarkers' BTI test for evaluating patients suspected of TBI. Banyan last month published a study in The Lancet Neurology detailing results from its ALERT-TBI study, which tested the markers in 1,959 subjects recruited across multiple sites. According to the study, the BTI test, which received approval through the US Food and Drug Administration's de novo premarket review pathway in February, distinguished between CT -positive and negative patients with a sensitivity of 97 percent, specificity of 37 percent, and a negative predictive value of 99.5 percent, indicating that it could reduce the number of CT scans used for suspected TBI cases by around 35 percent.

In a comment accompanying the study, researchers from Antwerp University Hospital questioned whether these findings supported use of the test, however, noting that clinical decision-making tools have shown similar levels of performance, as has the protein biomarker S100B, which is currently used in Europe.

Sanchez said that one reason ABCDx did not include GFAP in its first-generation test is that it is present at low levels in patient blood, making it poorly suited to a point-of-care device. He said the company also plans to develop versions of the test that will run on traditional clinical analyzers in, for instance, a hospital lab.

Sachez said H-FABP and an additional marker he did not disclose have also shown potential as markers for outcomes in CT-positive patients, the majority of whom, he noted, are fine and ultimately don't need medical intervention. If the markers were able to predict ultimate patient outcomes, "we could potentially set a higher cutoff and also discharge [without CT] patients who would be CT-positive but without complications," he said.

In addition to TBI, the company is exploring markers for distinguishing between ischemic and hemorrhagic stroke. The former is caused by blood clots in the brain, while the latter is caused by brain bleeding, meaning the two require different treatments. Ischemic strokes can be treated with tissue plasminogen activator, which helps dissolve the clot, but such treatment could be dangerous if given by mistake to a patient suffering a hemorrhagic stroke. Sanchez said ABCDx aims to develop a point-of-care test for distinguishing between the two that could ideally be given in ambulances, allowing clinicians to start the correct treatment as soon as possible.

The company is also working on markers to identify patients at high-risk of post-stroke bacterial infections with the goal of better targeting antibiotic treatment in these patients.

In addition to Sanchez, ABCDx was founded by Joan Montaner, director of the Neurovascular Research Laboratory at the Vall d’Hebron Research Institute, and Alan Cookson, a former pharma executive who has led several efforts spinning out life science technologies from the University of Geneva. Sanchez said the company has largely been funded by its founders to this point and has also raised investment from personal investors as well as family offices and small banks.

It has around 10 employees as well as collaboration deals with several hospitals for clinical research and with the University of Geneva and Vall d’Hebron Research Institute for research and development work, he said.