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In Brief This Week: Genedrive, Exosome Dx, Luminex, More

NEW YORK (GenomeWeb) – Epistem announced this week the completion of the management buyout of Genedrive following an undisclosed investment by Foresight Group. Epistem provides preclinical and clinical research services across specialist therapeutic areas, such as oncology, gastrointestinal diseases, and toxicity 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 GI disease models, the development of organoid and microbiota services, and an expansion into chronic disease models, such as fibrosis.

The buyout was led by Catherine Booth, an original founder of Epistem. Other members of the executive team will include another original Founder of Epistem Julie Tudor, and a new sales director and finance director. Nick Ash has joined the company's board as non-executive chairman.

Genedrive said last month that it signed an agreement to sell its contract research and pharmacogenomics division to Epistem for up to £1.9 million ($2.6 million). With the divestiture of those businesses, Genedrive will focus on the molecular diagnostics market. Genedrive was formerly called Epistem.

Exosome Diagnostics said this week that it has achieved ISO 13485:2016 certification for its Munich location, upgraded from the ISO 13485:2003 certificate. The certification paves the way for it as an in vitro diagnostic medical device design and manufacturing organization, the firm said. 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."

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, but it consolidates four individual consumables into a single cartridge within a closed system for a simpler workflow, the firm said. The new fully automated system will support up to six modules for random access testing at any given time.

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.

Abomics, a Finnish startup that markets a consumer pharmacogenetic test, has named Sweden's Gendokotorn Medicinsk as the distributor of the test that country. Abomics' test, GeneAccount Service, uses a buccal swab sample to test the response of 13 genes to more than 120 of the most common drugs.

OpGen said that it has modified the terms of its debt owed to Merck Global Health Innovation Fund. Specifically, it has extended the maturity of its $1 million second amended and restated senior secured promissory note, dated June 28, 2017, and said it would pay accrued interest through the issuance of shares of common stock in a private placement transaction.

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.