TEST:

Epi proColon®

P=N/A, N=529, Completed, Central Hospital, Nancy, France | Recruiting --> Completed | Trial completion date: Feb 2023 --> Oct 2024 | Trial primary completion date: Feb 2023 --> Oct 2024

ColonUSK indicated moderate diagnostic value and could become a non-invasive detection way for CRC. The implementation of the ColonUSK assay has the capacity to markedly enhance CRC screening practices.

Hypermethylated DNA biomarkers BCAT1, IKZF1 and SEPT9 were largely stable across different stages of disease and were highly selective for gastrointestinal adenocarcinomas relative to other cancer types. Existing CRC methylated ctDNA blood tests for BCAT1/IKZF1 and SEPT9 might be usefully repurposed for use in other gastrointestinal adenocarcinomas and warrant further prospective ctDNA studies.

However, compared with currently recommended annual FIT screening and 10-yearly colonoscopy screening, blood-based screening would result in lower effect and higher costs. Even with higher screening uptake, triennial blood-based screening with the CMS-specified minimum performance sensitivity of 74% and specificity of 90%, was not projected to be cost-effective compared with FIT screening and colonoscopy screening.

The Kappa test value for this experiment was 0.76, indicating a high degree of consistency between ColonUSK and pathological diagnosis. Our results suggest that ColonUSK holds potential as a non-invasive screening tool for colorectal cancer.

The study's insights into the differential expression patterns of these biomarkers can inform targeted screening strategies. Further research is needed to assess their potential to enhance early tumor detection in Hispanics.

"Epigenomics AG...closed...the agreement entered into on July 24, 2023 with New Day Diagnostics LLC ('New Day Diagnostics'), a U.S.-based diagnostics and contract research company, for the sale of its major assets. As a result, almost all of the Company’s assets have been transferred to New Day Diagnostics...The sale also offers the realistic possibility that Epigenomics’ intensive upfront work will benefit patients through the further development of the blood-based colorectal cancer screening test."

P=N/A; N=646; Completed; Sponsor:University of Miami

"Epigenomics AG...and New Day Diagnostics LLC...entered into an agreement for the sale of substantially all of the Company’s assets...The sale of the assets to New Day Diagnostics is expected to enable the commercialization of Epi proColon 'Next-Gen' and secure future cash flows for Epigenomics AG. In addition, the likelihood of reimbursement by CMS increases due to the option to combine the biomarkers of Epigenomics AG and New Day Diagnostic LLC, allowing the 'Next-Gen'-Test to make an important contribution to reducing the burden of colorectal cancer disease and deaths."

Semi-quantification of the single ctDNA marker, mSEPT9, a prevalent biomarker of CRC, was an independent predictor of PFS whereas CEA was not. High levels of both CEA and mSEPT9 ctDNA were independent predictors of OS, showing that mSEPT9 ctDNA added value to CEA in evaluation of OS. The mSEPT9 ctDNA test is rapid turn-around and easy to perform in molecular diagnostic pathology laboratories, thus may serve as a valuable adjunct to CEA for frequent testing in the setting of metastatic CRC.

The plasma SEPT9 DNA methylation level and Serum CCSA-2 could be used as promising non-invasive methods for observing the CRC patients postsurgical response to predict the occurrence of complete remission or relapses.

"Epigenomics AG...has decided to restructure the Company and to significantly reduce the Company’s operations...The Restructuring is carried out to minimize the Company’s costs. In addition, this is intended to extend the time period available to the Company to secure financing for the further development of the 'Next-Gen'-test for detecting colorectal cancer (CRC)...The Company will stop the sale of Epi proColon and recall the product."