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In Brief This Week: Illumina, Agilent, Thermo Fisher, and More

NEW YORK (GenomeWeb) – Illumina said this week that it recently received product approval certification for the NextSeq 550Dx sequencing platform from the Pharmaceuticals and Medical Devices Agency (PMDA) 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.

Agilent Technologies this week sent a letter to the Division of Corporation Finance of the US Securities and Exchange Commission regarding what it called "misstatements" in the S-1 Registration statement filed by Twist Bioscience for its IPO.

The letter alleges to the SEC that "Twist's S-1 fails to disclose that Twist CEO Emily Leproust formed Twist while an employee at Agilent, and became its CEO 17 months prior to resigning from Agilent." The letter also reiterates Agilent's claim that "Twist's S-1 fails to disclose the material fact that its CEO Emily Leproust and other Twist employees took and retained hundreds of confidential documents containing Agilent's trade secrets and proprietary information."

Thermo Fisher Scientific said this week that it has opened a new business center and biorepository in Frederick, Maryland. The recently expanded center will serve as the North American hub for the company's life sciences business. The expansion adds a facility that will house the Cryo-Innovation Center, which will support clinical trials and commercial cell and gene therapy, and the National Cancer Institute Repository for Clinical Trials, a central biorepository to support oncology clinical trials.

Thermo Fisher also said this week that it is collaborating with Symphogen to develop validated platform workflows to characterize and monitor the quality of complex therapeutic proteins. Under the terms of the two-year agreement, the partners plan to develop protein analysis workflows to accelerate drug development. Specifically, Symphogen will use the Thermo Scientific Q Exactive Plus Orbitrap liquid chromatography tandem mass spectrometry system with BioPharma Option to create and validate platforms for analyzing therapeutic monoclonal antibody mixtures. The companies will also develop automated multi-attribute method (MAM) workflows for monitoring quality attributes of proteins using mass spectrometry.

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. The lab has been developing the Augusta OncoTarget test, which includes the Illumina TruSight Tumor 170 panel that looks for variants in the DNA and RNA of 170 genes.

BGI, the Chulabhorn Royal Academy in Thailand, and the Eastern Economic Corridor Office of Thailand said this week that they have signed a letter of intent to collaborate on the development of a Precision Medicine Center in Thailand and on genomics research, including cancer research, genetic disease screening, and aging disease research. The first projects are expected to focus on the genomics of Alzheimer's disease in the Thai population and on thalassemia screening in Thailand. In addition, the Chulabhorn Royal Academy will adopt BGI's sequencing technology.

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 assist in performing the study.

Aptatek BioSciences said this week that the US Food and Drug Administration has granted Breakthrough Device designation for its system used to monitor blood phenylalanine levels in phenylketonuria (PKU) patients. Aptatek's 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, specifically targeting tests that are otherwise only available as central lab tests and require complex detection technologies such as mass spectrometry. PKU is an inherited disease in which patients do not adequately metabolize the amino acid phenylalanine, causing the phenylalanine 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.

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 of age and older with a suspected traumatic brain injury. Per the terms of the contract, the DOD has ordered 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 said.

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 FDA granted marketing authorization to Banyan Biomarkers for its commercialization to aid in the evaluation of patients with a suspected mild TBI or concussion.

Sonora Quest Laboratories announced this week that it will provide access to healthcare providers to uMethod Health’s RestoreU Method, a 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.

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