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In Brief This Week: Luminex, Genedrive, CoverMyTest, and More

NEW YORK (360Dx) – Luminex this week said that it recently began clinical studies for a gastrointestinal assay on the Verigene II, its sample-to-answer benchtop molecular diagnostic system in development. The Verigene II system contains the same core nanoparticle chemistry as the firm's current Verigene system. It consolidates four individual consumables into a single cartridge within a closed system for a simpler workflow, the firm said. At any time, the Verigene II fully automated system will support up to six modules for random access testing.

Foresight Group this week announced an investment of £2 million ($2.7 million) in the management buyout of the contract research business Epistem from Genedrive.

Genedrive had said last month that it signed an agreement to sell its contract research and pharmacogenomics division to Epistem. With the divestiture of those businesses, Genedrive will focus on the molecular diagnostics market. Genedrive was formerly called Epistem.

Epistem provides preclinical and clinical research services across specialist therapeutic areas, such as oncology, toxicology, and gastrointestinal and inflammatory diseases. Foresight's investment will enable Epistem to expand its next-generation sequencing and laser-capture technologies, the company said. Epistem is also planning investments in gastrointestinal disease models, the development of organoid and microbiota services, and an expansion into chronic disease models, such as fibrosis.

The Inova Personalized Health Accelerator has invested in a new software system from CoverMyTest to optimize and automate the workflow involved with prior authorizations. According to an Inova spokesperson, Inova provided an undisclosed amount of equity financing to CoverMyTest in a seed funding round.

Inova said that CoverMyTest is the only prior authorization (PA) service provider solely focused on assisting laboratories offering genetic and genomic testing. The web-based platform provides a hub-service model that determines when a PA is required, conducts patient eligibility checks, and delivers electronic PAs for physicians. The platform also provides insurance verification, documentation gathering, PA submission, and deductible management functions.

Walgreens and the Kaiser Family Foundation's Greater Than AIDS organization said this week that they are working with 220 health departments, AIDS service organizations, and other community organizations to help provide free HIV testing and information at participating Walgreens stores. Testing and information will be made available in more than 180 cities on National HIV Testing Day, which is Wednesday, June 27, between 10 a.m. and 7 p.m. local time.

BioLytical Laboratories and OraSure Technologies are donating test kits and Abbott Rapid Diagnostics is providing support for outreach. Local agencies will participate to provide free, confidential, and fast test results on site without the need to schedule an appointment, and counselors will be available to answer questions about HIV prevention and treatment options, Walgreens and Kaiser said.

Laboratory Corporation of America announced it has acquired Sciformix, a company that provides pharmacovigilance and regulatory solutions for biopharmaceutical and medical device clients. The company will become part of LabCorp's Covance drug development business. Sciformix's services include post-marketing safety and risk management, clinical development support services, regulatory affairs and operations, technology services, and real-world evidence solutions. The majority of Sciformix's 1,100 employees are based in Asia, which boosts Covance's global expansion efforts. In announcing the acquisition, LabCorp Chairman and CEO David King said that Sciformix strengthens Covance's position in the later phases of drug and device development, particularly for post-marketing pharmacovigilance and market access solutions.

Exosome Diagnostics said this week that it has achieved ISO 13485:2016 certification for its Munich location, upgraded from the ISO 13485:2003 certificate. John Boyce, president and CEO of Exosome Diagnostics, said in a statement that with the ISO 13485:2016 certification, the company "can continue advancements in the design and development of IVDs," and it can continue its efforts to CE mark them for early-stage disease detection. He said that the certification is "an essential part of the company’s strategy."

Bioinformatics firm Bluebee has been awarded ISO 13485:2016 certification. The certification covers medical device quality management systems and was awarded to Bluebee for its design and development of software solutions and data-processing algorithms for use in diagnostics and clinical reporting.

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.