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In Brief This Week: Thermo Fisher Scientific, Burning Rock, DermTech, More

NEW YORK – Thermo Fisher Scientific this week has completed its acquisition of specialty diagnostics company The Binding Site Group, from a shareholder group led by European private equity firm Nordic Capital, in an all-cash transaction valued at £2.3 billion, or $2.8 billion at current exchange rates. Thermo Fisher said The Binding Site’s more than 1,200 global employees will become part of Thermo Fisher's Specialty Diagnostics segment. The company first announced the agreement to acquire The Binding Site on Oct. 31, 2022. 

Burning Rock said this week that its OverC multi-cancer detection blood test has been granted breakthrough device designation by the US Food and Drug Administration, a classification that offers an eased assessment and review process for novel medical products. 

The OverC assay is intended for early detection of esophageal, liver, lung, ovarian, and pancreatic cancers in adults of either sex, aged 50-75 years old with average risk for cancer. In a case control study, the test demonstrated 69 percent sensitivity and nearly 99 percent specificity, and Burning Rock is now in the process of conducting prospective interventional validation studies in an asymptomatic population. 

DermTech announced this week that four commercial payors Blue Cross Blue Shield of North Carolina, South Carolina, Louisiana, and Kansas City will cover the firm’s DermTech Melanoma Test. The policies were announced pursuant to an independent technology assessment by a laboratory benefits manager and are similar to the policy created by the Centers for Medicare and Medicaid Services for the test, DermTech said in a statement. The firm also entered into an agreement with a Blues plan in Michigan. The test is now covered for about 104 million people in the US, it added. 

Datar Cancer Genetics said this week it secured US Food and Drug Administration breakthrough device designation for the firm's liquid biopsy to help diagnose inaccessible brain tumors. The India-based firm's blood-based TriNetra-Glio test uses proprietary circulating tumor cell enrichment and detection technology to aid identification of malignant brain tumors when they cannot be accessed for a brain biopsy or a biopsy is unsuccessful. The firm said it has also received CE marking for the test, which is sold in Europe under the name Trublood-CNS. 

Vienna-based QMD Services this week announced it has been certified as a notified body to determine whether diagnostic tests in the EU comply with the In Vitro Diagnostic Regulation, which is being phased in there. It becomes the eighth IVDR notified body so far. As parts of Europe transition to the IVDR, the shortage of notified bodies has raised concerns that diagnostic manufacturers may not be able to comply with the new regulations. 

ProPhase Labs said this week it closed its $4.6 million acquisition of the exclusive rights to Stella Diagnostics' BE-Smart Esophageal Pre-Cancer screening test and related intellectual property assets. The firm expects to commercialize the test within 18 months. ProPhase said last month it had reached a purchase agreement with Stella, and updated purchase figures in this week's announcement indicate Stella received $3.6 million in cash and $1 million in ProPhase common stock and will receive another $2 million in ProPhase common stock upon hitting a revenue-based commercial milestone within five years. Stella also will receive a 5 percent royalty based on the adjusted gross margin from commercialization of the intellectual property. 

Biological Dynamics said this week that it has filed arbitration against two former employees, Richard Young and Bryan Rice, alleging their misappropriation of the firm’s proprietary technology to benefit their new company Exokeryx, which it believes unfairly competes with its exosome-isolation ExoVerita platform. The company added that its investigation of the alleged theft of proprietary technology and other confidential information by its former employees is ongoing and additional legal action may be necessary. 

Alveo Technologies announced this week that it has signed a memorandum of understanding with the Barbados Investment and Development Corporation to codevelop its rapid, handheld, portable, and eco-friendly multiplexed molecular sensing platform. Called be.well, the platform pairs molecular assays with cloud-enabled data analytics for real-time disease, pathogen, and contaminant detection, analysis, and diagnosis at point of need. The partnership will enable scientists and life sciences industry leaders in Barbados to design new assays in the areas of infectious disease, agriculture, veterinary, food, medicine, and aquaculture testing. The firm will also bring its be.well platform and COVID-19 test to Barbados and refine its next-generation high-throughput platform with scientists in Barbados' emerging life sciences ecosystem. The partnership — which is part of Alveo's overall open source partnering model — allows Barbados to share intellectual property and revenue. 

Matrix Medical Network this week announced the sale of its Matrix Clinical Laboratory to Karrington Clinical Laboratory as part of Matrix’s refocus on in-home health and care assessments. The deal will provide Karrington with a CLIA-certified and College of American Pathologist-accredited diagnostic testing laboratory and will allow Karrington to focus on the continued growth of the lab, develop new molecular diagnostic testing and lab processes, and expand its testing menu using its minimally invasive phlebotomy technology, the companies said in a statement. 

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.