On September 2, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that a study recently published in BMC Cancer shows that blood tests, such as Epi proColon(R), can significantly increase the CRC screening rates in medically underserved populations (MUP) unwilling or unable to complete FIT or colonoscopy. For eligible participants, the rate of testing increased from 12.6% completing a FIT test the previous year to 93.5% with the blood test.

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Greg Hamilton, CEO of Epigenomics AG, commented: "CRC still is the second leading cause of cancer mortality in the U.S., despite the ability to reduce it through screening. Adherence to regular screening is key to earlier CRC detection thus reducing incidence and mortality. The findings now being published are in line with a series of previously published results that blood tests can make an important contribution to reducing the number of CRC related deaths, especially in medically underserved populations which are the most vulnerable."

In the U.S., many people are not up-to-date with CRC screening despite the available testing, with overall screening rates under 70%. This applies in particular to MUP, who share characteristics such as low income, lack of insurance or being underinsured. Although FIT has desirable characteristics for MUP, return rates are consistently low, around 10% in MUP compared to the general population. This was confirmed in the study now published. In the study, the patients were consecutively offered CRC screening by colonoscopy and FIT, according to the current guidelines for CRC screening. Only when both options were rejected, the blood test was offered. Of the 460 participants ultimately offered screening, no participant accepted the offer of colonoscopy, 30 (6.5%) chose FIT screening and 430 (93.5%) elected for mSEPT9 testing. Only two of the 30 participants who chose FIT returned the test (6.7%).

Hence, the study results show that the introduction of blood-based testing for CRC screening, when compared to FIT, has proven to be well-received by the participants, likely because of convenience and ease of testing. The result is another important contribution to the realization that FDA approved CRC screening blood tests should be incorporated into the screening paradigm, as this is a tangible solution to reduce CRC mortality.