DAWN™ IO | Melanoma is a laboratory developed test to assess whether a patient is likely to benefit from immune checkpoint inhibitor therapy, specifically nivolumab (Opdivo®) in combination with ipilimumab (Yervoy®) or pembrolizumab (Keytruda®) monotherapy.
INTERVENN’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). The DAWN IO Melanoma test was developed, and its performance characteristics were determined by INTERVENN. The DAWN IO Melanoma test has not been cleared or approved by the U.S. Food and Drug Administration. INTERVENN’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The DAWN IO Melanoma test is intended for clinical purposes.
The world’s first glycoproteomic, liquid-biopsy laboratory-developed test (LDT).
GLORI™ is an LDT for ovarian cancer diagnosis that has been validated using both retrospective patient samples and samples collected prospectively in InterVenn’s 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™ performs well among currently available blood-based tests used to manage patients with suspected ovarian cancer. [1,2] The VOCAL clinical trial reached full enrollment of the targeted patient cohort in southeast Asia earlier this year, with the completion of the trial's additional recruitment of patients in the United States and Australia anticipated by the end of the year.
| Indication | Clinical Application | Phase | |||||
|---|---|---|---|---|---|---|---|
| Proof of Concept | Classifier Validation | LDT Validation | Commercially Available | ||||
| Metastatic Melanoma | Immuno-Therapy Response Prediction - DAWN IO | ||||||
| Ovarian Cancer | Pelvic Mass Triaging - GLORI | ||||||
| Non Small Cell Lung Carcinoma (NSCLC) | Immuno-Therapy Response Prediction - DAWN IO | ||||||
| Advanced Adenoma | Pre-malignant Detection, Cancer Prevention | ||||||
| Colorectal Cancer | Early Cancer Detection, Colonoscopy Triaging | ||||||
| Prostate Cancer | Differentiation Between Indolent and Aggressive Variants | ||||||
| Non-Alcoholic SteatoHepatitis (NASH) | Early Detection, and Clinical Decision | ||||||
| Hepatocellular Carcinoma (HCC) | Early Detection, and Clinical Decision | ||||||
| Nasopharyngeal Carcinoma | Early Detection, and Clinical Decision | ||||||
| Renal Cell Carcinoma | Differentiation Between Indolent and Aggresive Variants | ||||||
| Pancreas Carcinoma | Early Detection | ||||||
| Non Small Cell Lung Carcinoma (NSCLC) | Early Detection | ||||||
Our goal has always been to help patients and physicians by providing products that provide unprecedented insight and benefit. We will continue to advance this cause by introducing new tests and applications and leveraging our analytical platform.
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