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In Brief This Week: Cleveland Diagnostics, Chembio Diagnostics, Renalytix AI, and More

NEW YORK – Cleveland Diagnostics said this week that its IsoPSA Assay for prostate cancer has received breakthrough device designation from the US Food and Drug Administration. The company has finished two multicenter clinical trials in the US, led by the Cleveland Clinic, comparing the diagnostic accuracy of IsoPSA with PSA. The results demonstrate that IsoPSA has superior performance in identifying patients with high-grade disease, the firm said. The underlying technology of IsoPSA, the Solvent Interaction Analysis (SIA) platform, is a protein biomarker discovery and assay method that uses different protein isoform populations to assess patient disease states. SIA looks at bulk levels of protein isoforms associated with a given disease.

Chembio Diagnostics said this week that the World Health Organization (WHO) has qualified the diagnostic firm's manufacturing facility in Malaysia to produce Stat-Pak HIV 1/2 tests through the WHO Prequalification of In Vitro Diagnostics (IVD) program.

The program requires a comprehensive assessment of individual IVDs through a standardized assessment process that includes inspection of the manufacturing site, review of a product dossier, performance evaluation including operational characteristics, and labelling review, Chembio said.

John Sperzel, CEO of Medford, New York-based Chembio, said in a statement that "investment in Malaysia is a key element of our growth strategy, commercially and operationally, and the WHO Prequalification approval represents a major milestone."

Renalytix AI said this week that Capital District Physicians' Health Plan will cover the company's KidneyIntelX test for qualified members who have type 2 diabetes and chronic kidney disease. CDPHP is a physician-led health insurance provider with members in 26 counties in New York. KidneyIntelX improves risk stratification and clinical management of patients with chronic kidney disease. It uses machine-learning algorithms to evaluate predictive blood-based biomarkers and information from a patient's electronic health record. 

OncoDNA said this week that it has achieved ISO13485:2016 certification. Being certified indicates that the company’s quality management system meets the most recent regulatory and quality requirements in the field of medical devices, the firm said.

Jean-Pol Detiffe, cofounder and CEO of OncoDNA, said in a statement that the new certification represents an "important step for OncoKDM, our web-based next generation sequencing data interpretation software, to remain a state-of-the-art product."

The Gosselies, Belgium-based firm added that the ISO 13485:2016 certification complements the ISO27001:2013 certificate that it received recently and that describes the requirements for the management of information security and helps the company to meet General Data Protection Regulation (GDPR) compliance.

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.