Blood-Based Multi-Cancer Detection Using a Novel Variant Calling Assay (DEEPGENTM): Early Clinical Results.
This is an early clinical analysis of the DEEPGENTM platform for cancer detection. Newly diagnosed cancer patients and individuals with no known malignancy were included in a prospective open-label case-controlled study (NCT03517332). Plasma cfDNA that was extracted from peripheral blood was sequenced and data were processed using machine-learning algorithms to derive cancer prediction scores. A total of 260 cancer patients and 415 controls were included in the study. Overall, sensitivity for all cancers was 57% (95% CI: 52, 64) at 95% specificity, and 43% (95% CI: 37, 49) at 99% specificity. With 51% sensitivity and 95% specificity for all stage 1 cancers, the stage-specific sensitivities trended to improve with higher stages. Early results from this preliminary clinical, prospective evaluation of the DEEPGENTM liquid biopsy platform suggests the platform offers a clinically relevant ability to differentiate individuals with and without known cancer, even at early stages of cancer.
['Ris|Frederic|F|0000-0001-7421-6101', 'Hellan|Minia|M|', 'Douissard|Jonathan|J|', 'Nieva|Jorge J|JJ|', 'Triponez|Frederic|F|0000-0001-7808-496X', 'Woo|Yanghee|Y|', 'Geller|David|D|', 'Buchs|Nicolas C|NC|', 'Buehler|Leo|L|', 'Moenig|Stefan|S|', 'Iselin|Christophe E|CE|', 'Karenovics|Wolfram|W|', 'Petignat|Patrick|P|', 'Lam|Giang Thanh|GT|', 'Undurraga Malinervo|Manuela|M|', 'Tuttle|Rebecca|R|', 'Ouellette|James|J|', 'Bose|Debashish|D|', 'Ismail|Nael|N|', 'Toso|Christian|C|']
DEEPGENTM cancer detection machine-learning liquid biopsy cancer screening cell-free DNA early detection