SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--InterVenn Biosciences today announced it has completed clinical and analytical validation in compliance with standards set by the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) of GLORITM, a liquid-biopsy diagnostic test capable of differentiating between malignant and benign female pelvic tumors. This test marks a significant milestone for InterVenn as it seeks to establish its proprietary mass-spectrometry-based, AI-powered technology as a scalable clinical platform capable of efficiently deploying glycoproteomic diagnostic tests for a range of indications.
GLORI™ is a laboratory-developed test (LDT) that has been validated using both retrospective patient samples and samples collected prospectively in InterVenn’s ongoing VOCAL clinical trial. Development of GLORI™ was advanced after compelling positive results were obtained in an interim analysis of the VOCAL trial. With an overall accuracy of 86%, GLORI™ outperforms all other currently available blood-based tests used to manage patients with suspected ovarian cancer.
“The company started by leveraging the decades-long work and accomplishments of its scientific co-founders, Drs. Carolyn Bertozzi and Carlito Lebrilla, and complementing them with a powerful, AI-driven data processing engine, to build a revolutionary discovery platform for analyzing the glycoproteome at unprecedented speed and scale, and, for the first time, making glycoproteomics accessible for actionable clinical research,” said Erwin Estigarribia, InterVenn’s COO. “In less than three years InterVenn has successfully interrogated more than a dozen medical conditions, assayed thousands of patient blood samples, and established definitive evidence for the ubiquitous biological impact and, in parallel, for the clear clinical utility of glycoproteomics. This gave us the confidence to embark on our first prospective clinical trial, VOCAL; and the results generated, now reflected in the translational productization of data into GLORI™ as a fully validated LDT, are of course extremely gratifying. They are a major step forward not only for InterVenn and its platform, but also for basic and clinical science: this is the first-ever clinical glycoproteomic test and, most importantly, for women’s health, and for patients in need of better options.”
“With the validation of GLORITM as the world’s first glycoproteomic LDT we have clearly demonstrated that glycoproteomics can be used to develop high-performance diagnostic solutions and that InterVenn has reached a new stage of operational maturity,” said Aldo Carrascoso, InterVenn’s CEO. “We are now looking to accelerate the development of new liquid-biopsy assays in our product pipeline, including a precision-medicine test for immuno-oncology therapy, leveraging the opportunities for which GLORITM has paved the way.”
The VOCAL clinical trial reached full enrollment of the targeted patient cohort in South-East Asia earlier this year, with the completion of the trial's additional recruitment of patients in the US and Australia anticipated by the end of the year.
InterVenn has not yet announced a date for commercial availability of GLORI™ as it seeks to create a harmonized approach for market introduction of all products currently in its pipeline.
About InterVenn Biosciences
InterVenn Biosciences has developed a proprietary glycoproteomic platform based on AI and mass spectrometry for the discovery of novel glycoproteomic biomarkers and their application to next-gen precision medicine. The company is working to find new solutions in a range of oncology indications, along with making its Vista suite of solutions available to its partners for advanced life-science R&D applications. For more information about InterVenn Biosciences, please visit the company’s website (www.intervenn.com).