Stockholm, Feb 15, 2022: Swedish molecular diagnostics company Elypta announces today the launch of the clinical study LEVANTIS-0087A (LEV87A), intended to validate the diagnostic performance of GAGomes – the complete profile of human glycosaminoglycans – as metabolic biomarkers for Multi-Cancer Early Detection (MCED). The study aims to detect any-type cancer in adults who show no symptoms or have any recent history of cancer.
The study builds upon proof-of-concept data shared at the American Society of Clinical Oncology (ASCO) conference in June 2021 which indicated that GAGomes could detect one third of all stage I cancers across 14 types. Elypta’s liquid biopsy exceed the performance of other proposed approaches that use biomarkers based on circulating tumor DNA, which have been shown to capture less than one in five stage I cancers in asymptomatic adults.
"We were surprised to find GAGomes altered in such a high percentage of stage I cancers in both plasma and urine, and across cancer types historically difficult to detect using these biofluids, for example in low-grade gliomas, slow-growing forms of brain tumors,” says Elypta CSO and co-founder Francesco Gatto. “We performed internal studies to validate the findings we presented at ASCO that convinced us that GAGomes have significant potential to be clinically useful for MCED. We are now looking forward to confirming these results in LEVANTIS-0087A, a study aiming to include over 9 000 participants.”
LEV87A is a retrospective population cohort-based case-control study enabled in part by the low sample volumes required by Elypta’s liquid biopsy.
“MCED presents a potential paradigm shift in cancer screening, enabling the early detection of multiple types of cancers with a single test – recently highlighted by the relaunch of the US ‘Cancer Moonshot’ initiative, calling out the potential of MCED in particular, “adds Elypta CEO Karl Bergman. “We believe our liquid biopsy will play a major role in realizing this potential.”
Karl Bergman, CEO, firstname.lastname@example.org Tel: +46 73 262 53 33.
LEVANTIS-0087A (LEV87A) is a retrospective in vitro diagnostics clinical validation population cohort-based case-control study to validate the diagnostic performance of free GAGome-based tests for multi-cancer early detection in adults asymptomatic for cancer with no recent history of cancer.
More information about LEVANTIS-0087A can be found at ClinicalTrials.gov (NCT05235009).
Elypta is a Swedish molecular diagnostics company focused on reducing cancer mortality by enabling earlier detection and closer monitoring. The metabolism-based liquid biopsy platform in development measures a novel panel of biomarkers and utilizes machine learning algorithms to generate cancer-type specific GAG scores. Elypta is advancing a broad study program across different cancers with the first indication expected to be early detection of recurrence in renal cell carcinoma. www.elypta.com.