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In Brief This Week: Sonora Quest, Illumina, Banyan, and More

NEW YORK (360Dx) – Sonora Quest Laboratories announced this week it will provide access for healthcare providers to UMethod Health’s RestoreU platform to assess a patient’s chances of having Alzheimer’s disease. The personalized approach uses AI to interpret data from a patient’s biospecimens, demographics, medical history, and lifestyle, among other things. Physicians can use the platform to develop individualized plans to manage or slow the progress of the disease in Alzheimer’s patients, the partners said.

Illumina said this week that it recently received product approval certification for the NextSeq 550Dx sequencing platform from the Pharmaceuticals and Medical Devices Agency in Japan. The company said this is its first IVD-registered instrument in Japan, allowing it to distribute the NextSeq 550Dx as a Class I medical device. The registration will also help it to develop more sequencing-based IVD solutions and to establish additional strategic collaborations with pharmaceutical companies in Japan.

Banyan Biomarkers said this week that the US Department of Defense has agreed to procure the Banyan Brain Trauma Indicator, Banyan BTI, a diagnostic blood test to rule out the need for a computed tomography scan of the heads of patients 18 years and older with a suspected traumatic brain injury. Per the terms of the contract, the DoD placed an order for the Banyan BTI tests for use in military installations that may include Fort Bragg, Fort Carson, Fort Hood, Fort Benning, Joint-Base San Antonio, Camp Pendleton, Fort Bliss, Fort Campbell, and Camp Lejeune.

Banyan BTI identifies two brain-specific protein biomarkers — ubiquitin carboxyl terminal hydrolase-L1 (UCH-L1) and glial fibrillary acidic protein (GFAP) — that are detected in the blood soon after a brain injury. The US Army Medical Research and Materiel Command supported the development of the assay, and in February the US Food and Drug Administration granted marketing authorization to Banyan Biomarkers for its commercialization to aid in the evaluation of patients with a suspected mild TBI or concussion. 

Kara Schmid, project manager for the Neurotrauma and Psychological Health Project Management Office for the US Army Medical Materiel Development Activity, said in a statement that finding a better way to diagnose and evaluate traumatic brain injuries has been a top priority for the DoD for more than a decade.

Epigenomics said this week that the Veterans Administration — New York Harbor Healthcare System (VA-Manhattan) will be using its Epi ProColon colorectal cancer screening blood test in a study to assess the adherence impact of offering a blood-based colorectal cancer screening test with colonoscopy for those testing positive in patients who have refused colonoscopy and fecal immunochemical testing. The study will be managed through The Narrows Institute, and the VA-Manhattan has received grants from the American Society for Gastrointestinal Endoscopy and the New York Society for Gastrointestinal Endoscopy to support performing the study.

Aptatek BioSciences said this week that the FDA has granted Breakthrough Device designation for its system used to monitor blood phenylalanine levels in phenylketonuria (PKU) patients.

Aptatek said that its test measures blood levels of the amino acid phenylalanine on a portable instrument that patients can use at home instead of having to visit clinics or mail blood samples to a central lab. This has been a long-term goal of the PKU community, physicians treating PKU patients, and companies developing therapies for PKU, the firm said.

The test system is supported by a cell phone app that enables users to evaluate changes in their phenylalanine levels over time.

Aptatek was launched by IPGroup to commercialize small molecule sensing technology developed at Columbia University that targets tests that are otherwise only available from central labs and require complex detection technologies such as mass spectrometry.

PKU is an inherited disease in which patients do not adequately metabolize phenylalanine causing it to increase to potentially toxic levels in the blood. PKU patients must monitor their phenylalanine levels throughout their lives to ensure that they maintain clinically safe levels. As a result, home-based monitoring has the potential to provide "a major advancement in patient care," according to Aptatek.

The Georgia Esoteric and Molecular Laboratory at the Medical College of Georgia at Augusta University said this week it has been selected as a designated laboratory for the National Cancer Institute's Molecular Analysis for Therapy Choice (MATCH) trial, which is assessing the effectiveness of targeting cancer-causing gene changes rather than cancer type. MCG is the seventh academic lab in the nation designated for the NCI-MATCH trial.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.