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In Brief This Week: Ortho Clinical Diagnostics, Thermo Fisher Scientific, Novigenix, HTG Molecular Diagnostics

NEW YORK – Ortho Clinical Diagnostics this week announced a collaboration with Thermo Fisher Scientific to expand menus on its MicroTip-capable Vitros Systems. The menu expansion enables testing for fentanyl, a commonly abused opioid, and tricyclic antidepressants, which have a narrow safe therapeutic range.

The Thermo Scientific DRI Fentanyl Assay has a sensitivity of 100 percent and cross-reacts with various analogs of fentanyl. The Thermo Scientific DRI Tricyclics Serum Tox Assay can help clinicians detect the use of tricyclic antidepressants in potential overdose victims, Ortho said. The DRI Fentanyl Assay is available in the US for criminal justice and forensic use only. The DRI Tricyclic Serum Tox Assay is 510(k) cleared by the US Food and Drug Administration.

In 2018, Ortho announced that it had signed an international distribution and copromotion agreement covering 14 assays with Thermo Fisher Scientific.

Immunotranscriptomics company Novigenix said this week that Helsana, the leading health insurance provider in Switzerland, has started coverage for Colox, the company's liquid biopsy test for the early detection of colorectal cancer. Individuals with the private outpatient supplementary insurance PRIMEO will be reimbursed for Colox. Colox is currently available in Switzerland through commercial partnerships with medical laboratories Unilabs and Dr Risch.

HTG Molecular Diagnostics announced this week that it will continue to abide by its existing obligations and complete all contracted work as part of a 2016 master assay development, commercialization, and manufacturing agreement with Qiagen subsidiary Qiagen Manchester. Tuscon, Arizona-based HTG said it will seek opportunities to develop new RNA companion diagnostics based on its EdgeSeq technology directly with BioPharma customers. The firm expects such work to leverage its existing 2014 diagnostic development agreement with Illumina. If HTG's RNA companion diagnostic program leads to global commercialization of products, the firm will be able to freely partner with a number of third parties to distribute and commercialize them. 

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.