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In Brief This Week: Cleveland Diagnostics, Genprex, Viome

NEW YORK – Early cancer detection diagnostic company Cleveland Diagnostics announced this week that its CLIA-certified reference laboratory received laboratory accreditation from the College of American Pathologists. In order to receive CAP accreditation, labs must maintain standards of accuracy, quality, and consistency. Labs must pass a site inspection, as well as examination of records and quality control procedures every two years. Inspectors also evaluate lab staff qualifications, equipment, facilities, safety, and overall management.  


Genprex said this week that a centralized institutional review board has approved the protocol for its Phase I/II Acclaim-1 study, in which researchers are evaluating its lead drug candidate quaratusugene ozeplasmid (Reqorsa) in combination with osimertinib (AstraZeneca's Tagrisso) as a treatment for EGFR-mutated non-small cell lung cancer patients who have progressed on prior osimertinib treatment. The centralized IRB will oversee the conduct of the study at 15 US sites and the enrollment of 92 patients. The company plans to conduct an interim analysis once 25 patients have experienced disease progression or died. Also this week, Genprex began recruitment within its Phase I/II Acclaim-2 trial, evaluating quaratusugene ozeplasmid plus pembrolizumab (Merck's Keytruda) in NSCLC patients with low tumor expression of PD-L1.


Viome said this week that its newly developed, saliva-based oral and throat cancer detection technology has received breakthrough device designation from the US Food and Drug Administration. The test uses the firm's proprietary mRNA analysis technology and artificial intelligence platform to detect cancer-associated signals that reflect the interaction between microbial activity and human gene expression.


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.