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In Brief This Week: Illumina, Thermo Fisher Scientific, FIND, and More

NEW YORK –  The US Court of Appeals for the Federal Circuit this week dismissed BGI's appeal of the scope of a preliminary injunction issued at Illumina's request in a patent infringement suit. Both BGI and Illumina asked the court to dismiss the appeal after the US District Court for the Northern District of California modified the injunction on Sept. 23 to allow BGI to continue internal research on its CoolMPS reagents.

Thermo Fisher Scientific said this week that the Lung Cancer Genetic Screening Project for Individualized Medicine in Asia (LC-SCRUM-Asia), based in Japan, will be using the company’s Ion Torrent Genexus sequencing system and Oncomine Precision Assay pan-cancer panel in two new projects to study non-small cell lung cancer. The new work is an extension of Thermo Fisher's ongoing collaborations with LC-SCRUM, which started in 2015 and involved the use of the Oncomine Comprehensive Assay in clinical trials.

Oncocyte has terminated the full-time employment of Albert Parker, its chief operating officer and secretary, Tony Kalajian, its chief accounting officer, and Lyndal Hesterberg, its chief scientific officer, as part of a cost-savings plan.

Parker, Kalajian, and Hesterberg each accepted an offer to continue to serve temporarily in their current positions on a part-time "at will" basis under the terms of a reduction in salary agreement, whcih includes a 50 percent cut to their bi-weekly salaries, but allows them to remain eligible to participate in Oncocyte's employee benefit and equity incetive plans. The firm expects the part-time employment to end on Dec. 18, 2020, although any party may also decide to terminate employment at an earlier date.

Caris Life Sciences said this week that New England Cancer Specialists has joined the Caris Precision Oncology Alliance, a collaborative network of leading cancer centers that demonstrate a commitment to precision medicine. Centers in this network collaborate to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology. The alliance comprises more than 40 academic, hospital, and community-based cancer institutions, including 16 National Cancer Institute-designated Comprehensive Cancer Centers.

Centogene said this week that it has been awarded ISO/IEC 27001:2017 certification for its information security management system. The certification verifies that the firm’s processes and IT systems support the highest level of confidentiality, availability, and integrity of all processed data, including data from patients, employees, customers, and business partners.

JetBlue Airways said this week that it is partnering with Vault Health to make SARS-CoV-2 testing available to customers with pending travel plans. The partners are offering an at-home testing option to flyers who need to prove they have tested negative for the virus in order to be allowed entry to certain states and countries, and to avoid mandatory quarantines. Customers will be able to administer an at-home saliva test via an online video through Vault while a supervisor ensures the sample is being properly taken. The sample will then be sent overnight to a lab, which will process and analyze it. Results are provided in 72 hours or less. JetBlue noted not all jurisdictions accept PCR test results for the coronavirus conducted with at-home tests or saliva samples. Vault offers a saliva-based SARS-CoV-2 test developed by the Rutgers Clinical Genomics Laboratory. The test, a modified version of an assay originally developed by Thermo Fisher Scientific, received Emergency Use Authorization from the US Food and Drug Administration in April.

Yourgene said this week that it has launched an integrated and expanded service offering called Yourgene Genomic Services (YGS), which will consolidate the firm's noninvasive prenatal testing and COVID-19 testing laboratories in Manchester, UK, with its research, oncology, and NIPT services in Taiwan. Yourgene will also expand the company's services for contract research organizations, pharmaceutical firms, and biotech partners to both Manchester and Taipei. As part of the additional CRO services, the firm will invest more than £500,000 ($642,000) in its laboratories’ facilities, equipment, and teams in both locations. It will also consider additional locations for YGS.

South Korean biotechnology firm Bioneer said recently that it has signed a turnkey project contract with the Ministry of Health and Welfare of Iraq to create a COVID-19 testing laboratory. As part of the $2.4 million contract, Bioneer will supply and set up the equipment and kits for molecular diagnosis and research. The company also said that it has developed a kit for the diagnosis of SARS-CoV-2 and flu, and that it will obtain CE mark and Korean FDA certifications for the test following clinical studies.

Venture capital firm Kurma Partners announced this week the first closing of the Kurma Diagnostics 2 (KD2) fund at €50 million ($59 million). Kurma Diagnostics is an investment fund dedicated to early-stage European diagnostic companies, and the second fund will be dedicated to molecular and digital technologies, the Paris-based company said. KD2 will provide funding to 15 companies specializing in molecular diagnostic tools, smart and connected diagnostic devices, or tools based on artificial intelligence. The €50 million raised surpasses the €35 million raised by its predecessor Kurma Diagnostics.

Exagen announced this week that it has entered into a preferred provider network agreement with Provider Network of America, providing 8 million patients in the US access to the company’s Avise tests for autoimmune disorders, such as rheumatoid arthritis and lupus. PNOA is accessed by 526 payors and has 12,000 hospitals and other facilities under contract.

The Foundation for Innovative New Diagnostics said this week that Optum Global Solutions (India) has pledged INR 2.20 crores ($294,000) to FIND India to improve testing capacity for SARS-CoV-2 in that country. Overall, Optum, part of UnitedHealth Group, has pledged about INR 11.45 crores to help the fight against coronavirus in India. FIND is working with the country’s government to scale up testing capacity by providing diagnostic equipment, test kits, and consumables. The organization is also investing in training and building laboratory staff capacity. With the Optum funding, FIND India aims to support public and government-run labs further increase their lab testing capacity.

HNL Lab Medicine said this week it has acquired NLM Laboratories for an undisclosed amount. Allentown, Pennsylvania-based HNL has more than 60 patient centers in Pennsylvania and New Jersey. NLM will keep its current name. Together, the two labs will generate more than 60 million clinical and anatomic pathology results for more than 3 million patients and 12,000 healthcare providers annually.

China-based precision oncology firm Genetron said this week that its blood-based next-generation sequencing test for early detection of liver cancers, HCCscreen, has been granted Breakthrough Device Designation by the US Food and Drug Administration. According to the company, the decision by FDA was based on evidence showing superior performance for HCCscreen compared to the current standard of care, which includes tools like ultrasound imaging and protein assays. HCCscreen is intended to be used as a screening tool for individuals who are designated to be at high-risk for HCC due to chronic HBV infection and/or liver cirrhosis.

Genetron has already commercialized HCCscreen in China as a lab-developed test. In addition to pursuing FDA approval of the assay, the firm is also currently building a lab in Maryland for which it intends to seek CLIA certification to serve global pharmaceutical companies.

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.