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In Brief This Week: Inotiv, MilliporeSigma, Luminex, Thermo Fisher Scientific, More

NEW YORK – Contract research organization Inotiv said this week that it has acquired genetic toxicology assets from MilliporeSigma's BioReliance portfolio, following MilliporeSigma's decision to discontinue its genetic toxicology operations. The assets include standard operating procedures, stock cultures, historic control data, and client lists. Under the sales-based royalty agreement, details of which were not disclosed, Inotiv, based in West Lafayette, Indiana, did not make any upfront payment. The company said it will ensure continuity of services for existing clients and plans to offer employment to certain MilliporeSigma employees. It also expects to lease space near MilliporeSigma's current facilities in Rockville, Maryland.

Luminex said this week in a filing with the US Securities and Exchange Commission that it has become a wholly owned indirect subsidiary of DiaSorin, following the completion of the previously announced merger of the two companies. In a separate statement, DiaSorin said it has completed the acquisition for a price of $37 per share, or a total equity value of approximately $1.8 billion. DiaSorin said the acquisition gives it access to Luminex’s multiplexing technology, a portfolio that will strengthen its current offering and expand its presence in the US.

Thermo Fisher Scientific said this week that it has opened a new plasmid DNA manufacturing facility in Carlsbad, California. The 67,000-square-foot facility, which follows current good manufacturing practice (cGMP) regulations, is designed to meet the growing demand for plasmid DNA-based therapies and mRNA-based vaccines. Thermo Fisher said it plans to add 150 employees at the site as manufacturing scales.

TruDiagnostic said this week that it has licensed "mitotic clock" technology from the Van Andel Institute and Cedars-Sinai Medical Center. Developed by epigenetics researchers at those institutions, the mitotic clock examines how many times a cell has undergone replication, and could be useful in clinical research and personalized medicine applications, TruDiagnostic said. For instance, the technology may be able to detect cell senescence, a biomarker for aging; unusually high levels of cell division, a potential biomarker for cancer or other diseases; and stem cell depletion. TruDiagnostic said it will work with researchers at the Van Andel Institute to further develop the technology. 

South Korean sequencing kit developer Celemics said this week that it has signed a 4.5 billion Korean won ($3.9 million) supply agreement with Tsingke Biological Technology, a Beijing-based genomic analysis company. Under the terms of the deal, Celemics will provide Tsingke with reagents and analysis software for using Barcode-Tagged Sequencing (BTSeq), Celemics' NGS library preparation technology. Celemics said the deal will run through Pocula, its China distributor.  

The Pandemic Response Lab, operated by Opentrons Labworks, and Brio this week announced they are partnering to offer COVID-19 testing and variant "zone" surveillance for the entertainment industry. Brio will provide sample collection services, logistics, reporting, advanced software, and support to entertainment facilities, while PRL will conduct the testing, which includes PCR testing and genome sequencing of positive results to track variants. PRL said it can provide PCR results in six hours or less. Financial and other terms of the deal were not disclosed. 

The Access to Comprehensive Genomic Profiling Coalition, a group working to expand insurance coverage of broad genomic testing panels for advanced cancer patients, this week announced Strata Oncology as its newest member. Like other members in the coalition, Strata offers comprehensive genomic profiling, using its StrataNGS panel, and combines patients’ genomic information with real-world data to provide information doctors can use to make personalized treatment plans. The company also operates a clinical trial platform.

Avacta Life Sciences said this week that its diagnostics division has achieved ISO 13485 certification for the quality management system for the manufacture and distribution of its Affirmer reagents for use in lateral flow, ELISA, and immunodiagnostic in vitro diagnostic devices. The ISO standard defines the requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices. The certification provides Avacta a practical foundation for addressing regulatory requirements and ensures the safety of its products, the company said in a statement. The certification also means the CE mark for the AffiDx SARS-CoV-2 antigen lateral flow test can be transferred to Avacta from its partner Mologic. 

ACT Genomics Holdings said this week that its next-generation sequencing-focused operation and laboratory at the Hong Kong Science Park has received accreditation from the College of American Pathologists. The new accreditation significantly strengthens the NGS testing services and R&D capacity for the company, which already has CAP-accredited laboratories in Taipei and Kanagawa, Japan. The 3,500-square-foot Hong Kong laboratory has a dual NGS testing platform from Illumina and Thermo Fisher, and is run by a team of eight laboratory technicians, ACT said. Apart from boosting the group's capacity for providing services and support, the three laboratories will continue to pursue research projects, helping ACT develop new products. 

Cue Health said this week that its Cue COVID-19 Test Kit has received regulatory approval from India's Central Drugs Standard Control Organisation for professional point-of-care use in India. The molecular test provides results within 20 minutes and connects to smartphones to report results. The test can also detect emerging variants, Cue 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 GenomeWeb.