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In Brief This Week: Exact Sciences, Sygnis, OmniSeq, and More

NEW YORK (360Dx) – Exact Sciences announced this week that the company will build additional laboratory facilities in Madison, Wisconsin. The new facilities, which the company first announced in its third quarter earnings conference call in October, is scheduled to open in mid-2019 and will enable Exact to meet increasing demand for Cologuard, its colorectal cancer screening test.

The company also purchased the existing office building on the same site, which it formerly leased. Once finished, the new facility and the company's existing lab will give Exact the capacity to process more than 4.5 million Cologuard tests per year.

Sygnis, under the Innova Biosciences brand name, this week partnered with Abingdon Health to provide Innova customers with full lateral flow assay development services. Innova will also be a preferred colloidal gold supplier to Abingdon. The deal combines Innova's in-house expertise in supporting lateral flow assay development from initial data through to R&D with Abingdon’s automated lateral flow manufacturing. Sygnis will also have access to Abingdon's ADXLR5 reader systems, which will expand Sygnis' custom lateral flow assay services to include bulk manufacturing. Financial and other terms of the deal were not disclosed.

OmniSeq, a subsidiary of Roswell Park Cancer Institute, this week received accreditation from the College of American Pathologists for its molecular diagnostics lab. The company markets next-generation sequencing assays, including a 144-gene panel that gauges somatic cancer mutations, and the immune profiling test Immune Report Card, which have also been approved by the New York State Department of Health. The analytical validation of the immune response assay was recently published in the Journal of Molecular Diagnostics.

Isnes, Belgium-based VolitionRx on Thursday reported a third quarter net loss of $3.9 million, or $0.15 per share, compared to a net loss of $3.5 million, or $0.15 per share, in the third quarter of 2016.

At the end of September, the firm had cash and cash equivalents of $13.8 million.

Volition President and CEO Cameron Reynolds said in a statement that within the quarter, the firm had moved forward its clinical product development in Asia, Europe, and the US and broadened its potential revenue base with sales from a recently announced research kit.

The firm said it has entered an agreement to participate in a large, multi-center study with the Great Lakes New England Clinical Validation Center funded by the US National Cancer Institute's Early Detection Research Network. The objective is to validate for US regulatory purposes its Nu.Q Colorectal Cancer Screening Test in a large, asymptomatic population. The study would provide about 13,500 asymptomatic screening samples of people aged 50 or over who have not previously undergone screening or received a diagnostic colonoscopy.

The firm said that it has received $1.5 million in non-dilutive funding from Sofinex and the Walloon Region of Belgium, bringing the total amount of non-dilutive funding from various agencies in the region to nearly $2.5 million.

Volition added that it expects to select the panel for its frontline Nu.Q Colorectal Cancer Screening Test by the end of this year. The panel will be subject to validation in a 4,300-subject trial in the first quarter of 2018, and in a cohort with more than 10,000 subjects in the second quarter of 2018.

The firm said that it expects that the product will have CE marking by the third quarter of 2018 and regulatory approval will follow in Asia in early 2019.

ClearLight Diagnostics announced this week it has licensed additional technology from Stanford University. The agreement is for IP covering inventions that can be applied to Clarity-processed tissues, specifically for the visualization and quantification of immunolabeled long process structures. Additional licensed inventions include a flow-assisted tissue-clearing device and a computational pipeline for automated image registration. They also cover the quantification of cells in immunolabeled whole tissue samples imaged using light-sheet microscopy, ClearLight said. Financial and other terms of the deal were not disclosed. Last year, the firm exclusively licensed novel microscopy and RNA interrogation technology from Stanford.

AccuRef Diagnostics this week announced its formation as a new division under Applied StemCell, an ISO-certified global provider of molecular and cellular reference standards for assay development, proficiency testing, and quality control. The ARD product catalog provides singleplex and digital PCR pre-validated multiplex reference standards in a diverse set of biorelevant formats, including genomic DNA, formalin-fixed paraffin-embedded cell blocks, slides and scrolls, and matched frozen cell pellets. In addition, the custom diagnostics division of ARD partners with pharmaceutical and diagnostics companies to develop custom-engineered variants and pre-validated mutation panels.

Aperiomics said this week that it has signed a partnership deal with Milenia, a company based in the North Central part of Mexico, which operates diagnostic labs in Mexico and South and Central America. Milenia will send biological samples from its customers to Aperiomics for full analysis and identification of all known pathogens, the firm said.

HudsonAlpha Institute for Biotechnology announced this week that it plans to continue and expand its Information is Powerinitiative. The initiative is a collaboration between HudsonAlpha and Kailos Genetics to offer free and reduced-cost genetic cancer risk testing for men and women in North Alabama. Through Nov. 7, 2018, free testing will be available to women and men, 28 to 32 years old,who reside in the counties of Madison, Jackson, Limestone, Marshall, or Morgan. The test screens for mutations in BRCA1 and BRCA2, as well as additional genes linked to other diseases, such as colorectal and prostate cancer.

Vela Genomics, a subsidiary of Vela Diagnostics, said that it has received ISO 13485:2016 Quality Management Systems Certification from the BSI group, the national standards body of the United Kingdom. The certification covers the design and provision of clinical genomic services, including analysis and interpretation of genes and biomarkers for clinical diagnosis.

ISO 13485:2016 specifies requirements for a quality management system and requires that an organization demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

NeoGenomics this week opened its new facility in Rolle, Switzerland. The facility will be used to provide esoteric testing for the global oncology research community, the company said.

Thermo Fisher Scientific said this week that its board of directors has declared a quarterly cash dividend of $.15 per share to be paid on Jan. 15, 2018 to shareholders of record as of Dec. 15, 2017.

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 360Dx site.