NEW YORK (GenomeWeb) – PerkinElmer announced this week that it has completed its acquisition of Euroimmun Medical Laboratory Diagnostics. The firm originally announced its intent to acquire Euroimmun in June for $1.3 billion.
HTG Molecular Diagnostics disclosed in a filing with the SEC this week that it has amended the first statement of work under a previously announced master assay development, commercialization, and manufacturing agreement it signed with Qiagen. The first statement of work, dated June 14, relates to the development and use of a next-generation sequencing-based clinical trial assay that is the subject of a project agreement between Qiagen and a pharmaceutical company. Initial-phased development activities under the first statement of work are complete, and the amendment relates to next-phase development activities. Qiagen has agreed to pay HTG a development fee in the low, single-digit millions of dollars for these activities, which are expected to be completed in early Q1 2018. In addition, HTG and Qiagen will share any incremental net profits generated as a result of the activities. Successful completion of the next-phase activities is expected to lead to further project development activities and potential commercialization of a companion diagnostic assay for a drug.
Immunovia announced this week that Sahlgrenska University Hospital is the first Swedish site to be part of PanFAM-1, a multicenter prospective validation study for the early diagnosis of familial pancreatic cancer in high-risk individuals. The study is designed to validate Immunovia's blood-based biomarker test, IMMray PanCan-d, and will analyze thousands of individuals for three years across sites in both the US and Europe. The other PanFAM-1 partners to date are Mount Sinai, the Knight Cancer Institute at Oregon Health and Sciences University, the University of Liverpool, and Ramon y Cajal Institute for Health Research.
Co-Diagnostics said this week that it is leasing a new and upgraded laboratory in Salt Lake City, Utah that meets Current Good Manufacturing Practices, which are enforced by the FDA, and has Biological Safety Level 2 capabilities that enable "enhanced in-house verification and validation activities." Co-Diagnostics CEO Dwight Egan noted that the site will help the firm reduce its dependence on outside locations to complete validations of the company’s products, and that it represents the next step in its growth as a developer of molecular diagnostics.
Clinical Genomics Pathology this week received CAP accreditation. The lab offers Clinical Genomics' Colvera liquid biopsy ctDNA assay, which is used to detect residual disease and recurrent disease in patients previously diagnosed with colorectal cancer. The test looks for the presence of epigenetic modifications of the BCAT1 and IKZF1 genes using PCR technology and reagents from Qiagen.
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.