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In Brief This Week: Thermo Fisher, Grifols, MDxHealth, Exosome Diagnostics, and More

NEW YORK (GenomeWeb) – Thermo Fisher Scientific said this week that it has qualified global reference laboratories Laboratory Corporation of America and Cancer Genetics to join its Next-Generation Sequencing Companion Dx Center of Excellence Program (COEP). To qualify for the COEP, all laboratory members must demonstrate high-level expertise in oncology testing, maintain a global footprint, and meet the criteria necessary to administer clinical trials for the development and commercialization of companion diagnostic products. As preferred partners, each laboratory will participate in oncology-focused clinical trials in collaboration with pharmaceutical companies and Thermo Fisher. The companies may also qualify for early access to Thermo Fisher's pipeline of platforms and assays, the company said. Beginning in August, CGI will start offering the Oncomine Dx Target Test, and LabCorp will begin offering the test later this year.

Grifols said that the American Red Cross laboratory in Charlotte, North Carolina, now screens blood samples collected in New Jersey, Pennsylvania, Maryland, Maine, Vermont, and New Hampshire with the Procleix Babesia assay under an investigational new drug study. The Procleix Babesia assay is designed to be a qualitative in vitro nucleic acid screening test for the direct detection of the Babesia parasite in whole blood specimens from human blood donors on the fully automated Procleix Panther system platform. The parasite is transmitted to humans primarily through tick bites but can be transmitted through blood. The data collected will be used in the submission process to seek FDA approval for the Procleix Babesia assay, which is designed to be used for routine screening by US blood banks on the Procleix Panther system.

MDxHealth announced this week that MVZ Dr. Stein & Kollegen medical laboratory has signed an agreement to become the first laboratory to offer the SelectMDx for Prostate Cancer test in Germany. Under the terms of the agreement, MVZ Dr. Stein & Kollegen medical laboratory in Mönchengladbach, Germany will purchase SelectMDx CE-marked IVD kits from MDxHealth, will offer the service to patients through their network, and will perform the testing.

YouScript and PDX announced this week that they have signed an agreement to give YouScript precision prescribing clinical decision support software to all PDX pharmacy software users who opt in. Pharmacists will now be able to advise patients when they have a high risk of gene-based adverse drug events, and work with their medical providers to order testing and optimize drug and dose selection based on each patient's pharmacogenomic profile, the companies said.

Exosome Diagnostics announced this week that it has moved into a new worldwide headquarters and clinical laboratory in Waltham, Massachusetts. The 35,000-square-foot facility was custom built for the company's patented liquid biopsy sample processing and analysis technologies, and significantly expands capacity at a critical time for its commercial business expansion, the company said. Exosome also said that it has received ISO 13485 certification for its US and German facilities. The British Standards Institution has certified Exosome Diagnostics under ISO 13485:2003 for design, development, manufacture, distribution, installation, and service of IVD medical devices.

Sygnis reported this week that its revenues for the first half of 2017 rose nine-fold to €3.0 million ($3.6 million) from €319,000 in H1 2016, primarily due to the sale of the company's own kits and devices. The firm's reported net loss for the first half of 2017 was €2.0 million, compared to a loss of €1.5 million for the same period in 2016. Adjusted net loss was €900,000, excluding one-time costs and non-cash charges relating to the acquisitions of Expedeon, CBS Scientific, and Innova Biosciences. As of June 30, Sygnis had cash and cash equivalents of €2.7 million.

Evotec announced a strategic collaboration on induced pluripotent stem cell (iPSC) technology with the Fraunhofer Institute for Molecular Biology and Applied Ecology IME, ScreeningPort (Fraunhofer IME-SP), Hamburg. Through this add-on partnership to an existing Evotec/Fraunhofer cooperation agreement signed in 2014, Fraunhofer IME-SP will provide access to its technology portfolio including genetic characterization techniques and quality control procedures to support Evotec's patient-derived iPSC platform. The contract will run for an initial period of two years. Financial terms were not disclosed.

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