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In Brief This Week: Agilent, Unilabs, Caris Life Sciences, and More

NEW YORK – Agilent Technologies said this week that it has launched the Biomarker Pathologist Training Program,  which the firm believes will help pathologists accurately and confidently score biomarkers for identifying accurate treatments for patients. The program will use a digital platform called Pathcore Scholar, where attendees can navigate both standard and challenging cases. Agilent said the program will initially be available in Europe and North America, followed by China and Asia. The firm will offer training at different levels and both in-person and remotely to address individual training requirements. 

Unilabs said last week that it has opened a new COVID-19 testing lab in Porto, Portugal, which will allow the Swiss company to ramp up the number of daily coronavirus tests it performs to 15,000 from 6,000. The lab will process samples mainly from Portugal, but it can also test patient samples from elsewhere in Unilabs network. The company said that it has processed more than 3 million PCR COVID-19 tests and more than 1 million COVID-19 antibody tests across 17 countries.  

Caris Life Sciences announced that Spain's Vall d´Hebron Institute of Oncology has joined its Precision Oncology Alliance, a collaborative network of over 40 leading 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. 

Established in 2006, VHIO is a leading research center with a dedicated focus on translational efforts. According to Chadi Nabhan, chairman of the Caris POA, international alliance members like VHIO support the alliance's goal to expand broad-based collaboration among member institutions and to improve outcomes for cancer patients worldwide. 

Sema4 announced this week that it has opened a 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. 

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.  

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 ptions, 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. 

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. 

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. 

Toronto-based StageZero Life Sciences said this week it has closed a public offering of 9,243,700 units at C$.78 ($.61) per share for gross proceeds of C$7.2 million ($5.6 million). Each unit comprised of one common share of StageZero's stock and half of a warrant to purchase one common share of the company's stock. Each warrant can be exercised to purchase one common share before Dec. 4. 2023 at C$1.10 per common share. The company plans to use net proceeds from the offering to expand its capacity to offer and conduct COVID-19 testing and to develop its product line, including Aristotle, a pan-cancer test for the early identification of 10 discrete cancers from a blood sample. Echelon Wealth Partners and Clarus Securities acted as agents on the transaction. 

StageZero also completed a concurrent private placement of 325,456 units at C$.78 per share to an arm's length service provider to settle invoices of $193,119.04 owed by StageZero, it said. 

Specific Diagnostics said this week that it has received ISO 13485 certification through the International Organization for Standardization. The company said that it has started the European launch of its Reveal rapid antimicrobial susceptibility testing system and associated disposables. While ISO 13485 quality management system certification is not required to market the system in Europe, it provides assurance to customers that Specific's instruments and disposables have been manufactured to the highest standards, Specific Dx said.

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.