Study Published in American Health Drug Benefits Suggests that Non-Invasive Screening Methods, Including Epi proColon, Could Be A Cost-Effective Option To Help Achieve Target U.S. Colorectal Cancer Screening Rates

Berlin, 24 July 2019 - Epigenomics AG (FSE: ECX, OTCQX: EPGNY; the "Company"), a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology, today reported new study results suggesting that Epi proColon^(R), a CRC screening test approved for patients who are unwilling or unable to be screened by recommended methods, is a cost-effective approach for increasing CRC screening rates. While the U.S. CRC screening rate target is 80% the actual screening rate for CRC is only about 65%, creating a screening gap that requires new solutions. The study, led by a team from the Hutchinson Institute for Cancer Outcomes Research, used an economic simulation model evaluating the budget impact of Epi proColon and two stool-based CRC screening tests, appears in the current issue of American Health Drug Benefits.^[1]

"Colonoscopy-based screening for CRC is known to reduce mortality, yet nearly 35 percent of individuals who are eligible do not comply with current screening recommendations," said Scott Ramsey, MD, PhD, Director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center and senior author on the publication. "The results of this simulation support a role for blood- and stool-based test methods in increasing participation in CRC screening and suggest that similar clinical detection rates are achievable with the three non-invasive blood- and stool-based screening methods. Recent data suggest that not being up-to-date with CRC screening is associated with an approximate three-fold risk for CRC-related mortality, underscoring the critical need for alternative strategies, such as Epi proColon, that enable improved compliance with screening recommendations."

The simulation model is designed to estimate the three-year clinical and economic impacts for methylated SEPT9 (Epi proColon) and two stool-based screening tests (fecal immunochemical testing [FIT] and the multianalyte fecal test combining FIT and stool DNA [Cologuard]) compared with no screening in the population of patients who are eligible but non-compliant with CRC screening recommendations. The model reflects a theoretical commercial health plan population of one million members, and assumed that of the 232,000 screening eligible members (ages 50 to 64) there were approximately 81,200 individuals who were unscreened. The study assessed the clinical and economic impacts of screening approximately 34,800 of these 81,200 individuals, which would achieve the 80% screening rate target.

Model inputs were based on validation studies of the various screening methods, the U.S. census and other sources in the peer-reviewed literature. The costs included those for CRC screening tests and procedures and associated primary care visits, as well as diagnostic workup (imaging and/or colonoscopy, pathology). The costs of CRC treatment and end-of-life care were also estimated. Key findings from the study include:

• The number of new CRC cases over three years estimated by the model was 221 for Epi proColon, 216 for FIT and 193 for FIT/DNA, compared with 49 for no screening.
• The number of advanced adenomas detected over three years estimated by the model was 609 for Epi proColon, 305 for FIT and 830 for FIT/DNA.
• The number of non-advanced adenomas detected over three years estimated by the model was 1,115 for Epi proColon, 1,117 for FIT and 1,233 for FIT/DNA.
• The 3-year per-patient per-month cost impact for screening versus no screening was $0.67 for Epi proColon, $0.33 for FIT; and $0.69 for FIT/DNA.
  • These costs increased to $1.08, $0.71, and $0.98, respectively, when treatment costs for CRC were included.
  • Considering only the costs of screening and diagnosis, the costs for Epi proColon and FIT/DNA were almost the same ($0.67 and $0.69, respectively) and the cost for FIT was lower ($0.33).
• There is a modest tradeoff between cost and the number of cases detected with each of the screening strategies.

The study authors conclude that, for patients unwilling to be screened with colonoscopy, non-invasive blood- and stool-based screening methods can shift CRC detection to earlier, more curable stages of illness with similar cost. Given that individuals are more willing to have a blood test than take a stool sample at home,^[2] the authors also conclude that Epi proColon may allow health plans to achieve the U.S. CRC screening goal of 80%.

The results of this study add to the growing body of data supporting the clinical and cost benefits of Epi proColon. SEPT9 was also included in a cost-effectiveness microsimulation analysis of new non-invasive colorectal cancer screening tests, reported at Digestive Disease Week (DDW) 2019. Although the analysis reported at DDW was based on a prior version of the test, annual screening with SEPT9 demonstrated a significant reduction in the incidence and mortality of CRC, and was the most cost-effective of the new tests.^[3] These results also align with clinical outcomes from a new microsimulation model for CRC screening developed at Harvard Medical School and awaiting publication.

"Achieving the U.S. CRC screening target of 80 percent is critical for reducing the incidence and mortality of this often deadly cancer," said Greg Hamilton, Chief Executive Offer of Epigenomics AG. "Colonoscopy has helped to transform CRC from a lethal cancer to a treatable disease, but its benefits only accrue to those individuals who are willing and able to undergo the procedure at recommended intervals. Providing non-compliant patients with alternative screening options is essential for increasing CRC screening by 15 percent over current levels. Unlike colonoscopy and stool-based tests, which require that patients take some sort of action after leaving the physician's office, Epi proColon is a cost-effective screening test that can be performed during a routine office visit. We believe Epi proColon has an important role to play in bridging the CRC screening gap."

About Colorectal Cancer (CRC)
Colorectal cancer remains a leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35% of eligible U.S. patients are not being screened regularly. The unscreened population disproportionately results in 43% of new colorectal cancer cases and about 76% of colorectal cancer deaths and costs. Approximately $18 billion is spent annually on this preventable disease. Over $13 billion is spent on cases from unscreened individuals.

By increasing screening and detecting more cancers early, the costs and deaths from this disease both can be addressed.

About Epi proColon(R)
Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods. It is a qualitative, in vitro diagnostic blood test for CRC that uses real-time PCR to detect methylation of a target DNA sequence within the Septin 9 gene promoter; methylation of this DNA sequence is associated with the occurrence of CRC and can be detected in cell-free DNA that circulates in the plasma.

For patients, the test only requires a simple blood sample draw as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.

Epi proColon is recipient of the 2019 Excellence in Molecular Diagnostics by Corporate LiveWire's Innovation and Excellence Awards.

For more information on Epi proColon, visit www.epiprocolon.com.

About Epigenomics
Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics' lead product, Epi proColon, is a blood-based screening test for the detection of colorectal cancer. Epi proColon has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in the United States, Europe, and China and selected other countries. Epi proLung(R) and HCCBloodTest, blood-based tests for lung and liver cancer detection, has received CE mark in Europe.

For more information, visit www.epigenomics.com.

Contact:
Investor Relations
IR.on AG, Frederic Hilke, Tel +49 221 9140 970, E-Mail: ir@epigenomics.com

Company
Contact Epigenomic U.S., David Bull, Phone: +1 240.912.6430, David.Bull@Epigenomics.com

Media Contact
Lazar Partners, Erich Sandoval, +1 917-497-2867, esandoval@lazarpartners.com

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This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

^[1] Roth JA, deVos T, Ramsey SD. Clinical and budget impact of increasing colorectal cancer screening by blood- and stool-based testing. Am Health Drug Benefits. July 2017.

^[2] Liles EG, Coronado GD, Perrin N, et al. Uptake of a colorectal cancer screening blood test is higher than of a fecal test offered in clinic: a randomized trial. Cancer Treat Res Commun. 2017;10:27-31.

^[3] Peterse EF, Meester R, de Jonge L, Alarid-Escudero, Zauber AG, Lansdor-Vogelaar I. Comparing the cost-effectiveness of new colorectal cancer screening tests. Gastroenterol. 2019;156(6):S-21.