NEW YORK – In a filing with the US Securities and Exchange Commission this week, Luminex said it became a wholly owned, indirect subsidiary of DiaSorin, and the previously announced merger of the companies has been completed.
DiaSorin announced in a separate statement that it completed the acquisition for a price of $37 per share, or a total equity value of approximately $1.8 billion. 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, DiaSorin said.
Cue Health said this week that its Cue COVID-19 Test Kit has received regulatory approval from the 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.
Avacta Life Sciences said this week that its diagnostics division has obtained ISO 13485 certification for the quality management system for the manufacture and distribution of its Affimer 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. Avacta said the certification provides a practical foundation for addressing regulatory requirements and ensures the safety of its products. The certification also means that a CE mark for the AffiDx SARS-CoV-2 antigen lateral flow test can be transferred to Avacta from its partner Mologic, Avacta added.
The Pandemic Response Lab and Brio this week announced they are partnering to offer COVID-19 testing and variant surveillance for the entertainment industry. Brio will provide sample collection services, logistics, reporting, advanced software, and support to entertainment facilities. PRL, operated by Opentrons Labworks, will conduct PCR testing and genome sequencing of positive results to track variants. PRL can provide results from PCR testing in six hours or less, the firms said in a statement. Financial and other terms of the deal were not disclosed.
Ott Scientific said this week it is merging its four legacy organizations into one business called Ethos Biosciences. Ethos will operate four product lines and service brands — American Bionostica for lateral flow products; Astral Diagnostics for histology and hematology stains and reagents; Exocell for research and clinical nephrology assays; and Astral Rx for pharmaceutical formulations. Ethos will serve the diagnostics market, including healthcare, biotechnology, veterinary, and food and environmental testing. It will operate in Newtown Square, Pennsylvania, and Logan Township, New Jersey.
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. 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.
TruDiagnostic said this week 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, which may be a biomarker for cancer or other disease; and stem cell depletion. TruDiagnostic said that it will work with researchers at the Van Andel Institute to further develop the technology.
MedMira, a developer and manufacturer of rapid diagnostic tests, said this week that it has closed a C$500,000 ($396,648) equity investment with a Canadian investor to increase its operational capacity. The equity investment, fully diluted, represents less than 1 percent of its total shareholding. Under the terms of the deal, the investor will acquire 2,711,496 equity units at $0.18444 per unit.
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, Taiwan, 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 qualified 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.
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.