NEW YORK - Molecular diagnostics laboratory OmniSeq of Buffalo, New York, said this week that it has received ISO 13485:2016 certification for its quality management system. The certification, provided by SGS North America, demonstrates the firm's commitment to stringent regulatory and quality management systems across its clinical diagnostic testing operations, biopharmaceutical development solutions, and bioinformatic analyses, OmniSeq said.
Sema4 announced this week that it has opened a new clinical laboratory in Stamford, Connecticut. The 70,000 square foot facility is designed to process thousands of genomic tests per day and will host more than 300 employees, including 100 non-lab employees such as genetic counselors, bioinformaticians, and support staff. The lab has been licensed by the Connecticut Department of Public Health and replaces Sema4's New York lab.
Yourgene said this week that the National Health Service (NHS) England has recommended the routine use of DPYD testing prior to chemotherapy with 5-Fluorouracil (5-FU) in order to determine risk of severe side effects. According to the company, NHS England's statement supports the use of Yourgene's Elucigene DPYD test, which is already routinely used in Wales. The genotyping test can identify cancer patients with dihydropyrimidine dehydrogenase (DPD) deficiency, which can lead to severe side effects from 5-FU.
Metagenomics technology company IDbyDNA said this week that it has been accredited by the College of American Pathologists based on an onsite inspection. The accreditation was given by CAP's accreditation committee. The San Francisco-based firm noted that during the inspection, its laboratory records and quality control procedures for the preceding two years are examined. CAP inspectors also examine lab staff qualifications, equipment facilities, safety program and record, and overall management.
Canadian diagnostic firm LuminUltra said this week it has acquired Source Molecular, a provider of laboratory-based testing for the microbial source tracking of pathogens, including SARS-CoV-2, for an undisclosed amount. The acquisition expands LuminUltra's range of molecular testing options, and customers can have their samples tested remotely via mail-in service to Source Molecular or onsite with LuminUltra's GeneCount qPCR tests, it said.
Caris Life Sciences has announced that Spain's Vall d'Hebron Institute of Oncology has joined its Precision Oncology Alliance, a collaborative network of over 40 cancer centers working to advance comprehensive cancer profiling, establish standards of care for molecular testing in oncology, and investigate new predictive and prognostic biomarkers. Members gain early access to Caris MAI (Molecular Artificial Intelligence) offerings and are also able to integrate with a growing portfolio of biomarker-directed biopharmaceutical trials.
Brooks Automation has acquired Trans-Hit Biomarkers, a worldwide biospecimen procurement service provider based in Montreal. Terms of the deal were undisclosed.
SeeGene has received CE-IVD marking for its Allplex SARS-CoV-2/FluA/FluB/ Assay, a real-time RT-PCR test for the simultaneous detection and differentiation of eight target genes, including Flu A/B, RSV A/B, and the S gene, RdRP gene and N gene for SARS-CoV-2. The CE-IVD mark was received in September, the South Korean diagnostics company said. The assay includes dual targets for internal control in the same reaction tube, and verification of the whole test process and proper sampling can be performed without compromising the accuracy of the test results, Seegene said.
Singaporean biotech firm Veredus Laboratories said this week that that country's Health Sciences Authority has provided provisional authorization for the company's ZeroPrep Saliva Collection Kit and extraction-free VereRT ZeroPrep COVID-19 PCR Kit for use in combination to detect SARS-CoV-2 in patients. Veredus can now offer the products to healthcare institutions, private hospitals, medical clinics, and clinical laboratories in Singapore. Along with its use with saliva samples the VereRT ZeroPrep COVID-19 PCR Kit can be used with nasopharyngeal swabs, Veredus noted.
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.