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Universal Diagnostics (UDX) on Monday announced that data presented at the European Society for Medical Oncology (ESMO) virtual congress suggest its investigational methylation marker panel based on cell-free DNA (cfDNA) could allow for the early detection of colorectal (CRC), lung, pancreatic and breast cancer, as well as help with correct tissue-of-origin assignment. The company said a second study also demonstrated positive results for its experimental advanced adenoma detection blood test.
"These data…continue to show that our cfDNA panels have potential for use in the early, blood-based detection of CRC, our lead indication, but also in other cancers types, all with high sensitivity and specificity," remarked CEO Juan Martínez-Barea. "We intend to complete our ongoing verification study by the end of 2020 and plan to finalise internal validation of our CRC/AA test by the end of 2021," he said, adding that at the same time, "we will expand our cancer diagnostic platform to create more substantial data for other cancers, for example, the most frequently diagnosed cancers, such as lung cancer."
In the first study, investigators evaluated the methylation marker panel's performance in plasma samples of 101 patients with cancer and 71 age- and gender-matched non-cancer controls. The test correctly identified 100% of the CRC cases, 80% of the pancreatic cancer cases, 75% of the breast cancer cases and 73% of the lung cancer cases, with 90% specificity. Researchers also noted that the sensitivity for stage I cancers was 75%. Further, the test allowed for correct tissue-of-origin assignment in 80% of CDC patients, as well as 78% of lung cancer, 75% of pancreatic cancer and 62% of breast cancer cases.
Co-author James Kinross said "these data need now to be validated in larger prospective cohorts, but it does suggest that UDX are developing a highly promising and minimally invasive blood-based cancer screening test to detect and ultimately prevent multiple cancers."
The second study looked at the performance of the company's plasma cfDNA chromatin conformation marker panel for the detection of advanced adenoma. Plasma cfDNA whole genome sequencing data from 10 pooled samples, including two from AA, three from CRC stage I and five from controls, were used as a training set for open-chromatin region filtering and model building. The test was validated using data from 10 patients with AA and the same number of matched controls.
Results showed that half the AA samples were correctly identified at 90% specificity. Specifically, the test could detect 100% of serrated adenoma, 50% of tubulovillous adenoma and 25% of tubular adenoma. Moreover, the detection rate was 50% each for patients with high- and low-grade dysplasia. The company said the study "confirms the test's ability to pick up the signal coming from advanced adenomas."
"Previous research suggests that kinetic analysis and molecular profiling of cfDNA could potentially be used in non-invasive cancer detection and management. The data presented at ESMO 2020 supports this proposition, particularly in screening for colorectal adenomas," remarked Michael Roehrl, member of the company's scientific advisory board.
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