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In Brief This Week: Quest Diagnostics, Centogene, ArcherDx, and More

NEW YORK – Quest Diagnostics said this week that it has completed the acquisition of its joint venture partners’ interests in Mid America Clinical Laboratories. The deal was originally announced in June. Quest now wholly owns MACL’s lab in Indianapolis and about 50 patient service centers in Indiana. It also now provides lab management services for about 30 hospitals owned and operated by Community Health Network and Ascension St. Vincent — former JV partners in MACL — in Indiana. AmeriPath, Quest’s specialty diagnostics business, will continue providing those services to these hospitals and across Indiana.

Centogene said this week that it is expanding an ongoing partnership with the Ministry of Health and Social Protection of Tajikistan to include SARS-CoV-2 testing. Under the not-for-profit project, the country's National Reference Laboratory in Dushanbe has received reagents, laboratory devices, swabs, and transport systems for qPCR testing. Centogene will train Tajik experts to conduct SARS-CoV-2 testing using its standard operating procedures and training tools. The original collaboration, signed in July 2019, covered rare diseases and included training of doctors, pro bono diagnostic testing, and access to patient networks. It is jointly funded by Centogene and the German government.

ArcherDx announced this week that it is extending its partnership with UCL and the Francis Crick Institute to use liquid biopsy-based research assays for the Cancer Research UK-funded TRACERx program. ArcherDx and UCL will continue measuring circulating tumor DNA taken from peripheral blood draws at specific intervals to detect evidence of disease progression in lung cancer patients. The partnership uses ArcherDx’s Anchored Multiplex PCR technology to detect low levels of cancer-derived DNA, the firm said.

The Foundation for Innovative New Diagnostics FIND is partnering with Crown Agents as part of Accelerating Sustainable Control and Elimination of Neglected Tropical Diseases (ASCEND), a UK government initiative to drive progress towards global targets for the control and elimination of neglected tropical diseases. FIND will collaborate with the Kenyan Ministry of Health to strengthen testing for visceral leishmaniasis and address current VL outbreaks in the country by increasing access to rapid tests. The disease, which is caused by protozoan parasites and transmitted through the bites of sand flies, affects 1,200 people each year in Kenya. It is almost always fatal if not diagnosed and treated.

Australian regulators have authorized Co-Diagnostics' Logix Smart COVID-19 test for use in the country to detect SARS-CoV-2, the company announced this week. The Australian Government Register of Therapeutic Goods Certificate was issued to Co-Diagnostics' distributor in Australia, allowing it to supply the Class 3 IVD in Australia.

UgenTec this week announced the extension of a collaboration with the Belgian government involving PCR data analysis automation for high-throughput SARS-CoV-2 laboratories. Sites at the University of Liege and Biogazelle have automated the data analysis of PCR results using UgenTec's FastFinder Analysis solution. During Belgium's COVID-19 peak, the firm recorded up to 20,000 samples being processed with FastFinder in a single day, according to the company. 

The Cleveland Clinic said this week it has joined Grail’s PATHFINDER study, a prospective, multi-center effort that is evaluating the implementation of the company’s investigational multi-cancer early detection blood test in clinical practice.

The company’s assay, recently named Galleri, uses methylation patterns to distinguish the presence of cancer-associated DNA molecules circulating in the blood. It can also predict the area of the body in which these signals originated. In PATHFINDER, testing is being conducted under an investigational device exemption approved by the US Food and Drug Administration. Cleveland Clinic is joining other partners that include Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, and Sutter Health. 

Todos Medical this week announced that it has entered into a purchase agreement and registration rights agreement with institutional investor Lincoln Park Capital Fund. Upon execution of the purchase agreement, Lincoln Park bought $275,000 of Todos' common stock at $.08 per share. Todos said that over the next 24 months, it has the right to sell up to $10 million of its common stock to Lincoln Park in addition to the initial purchase.

T2 Biosystems said this week that it has chosen not to seek authority from the stockholders at its annual meeting to effect a reverse split of its issued and outstanding shares of common stock.

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.