Epigenomics | Top In-Vitro Diagnostic Technology Solution Company 2019

MedTech Outlook Magazine

Epigenomics
Breaking Grounds with Blood-Based Cancer Detection

Noel Doheny, CEO, EpigenomicsNoel Doheny, CEO
In a bid to find simple, effective, and non-invasive methods for detecting hard-to-diagnose cancers, researchers in the medical arena have been coming up with new diagnostic tools and innovative screening tests. The long haul finally paid off when a novel technique known as liquid biopsy was developed, which detects cancer easily and quickly using blood. The new test, which relies on analyzing cancer-related DNA found in bodily fluids, is believed by many healthcare professionals to be a significant milestone in cancer detection. Tapping into the immense potential of this medical procedure is Epigenomics, a Berlin-headquartered molecular diagnostics company that develops and commercializes patient-friendly, blood-based diagnostic tests across cancer indications with a high medical need. Through its unique, proprietary DNA methylation biomarker technology, the company is breaking grounds in diagnostics of colorectal and lung cancer.

Noel Doheny, CEO of Epigenomics Inc. says, “A recent report reveals that 76 percent of colorectal cancer (CRC) related deaths are associated with the lack of screening. The main reason behind this is the patient barriers associated with traditional imaging and stool-based screening.” In the U.S. alone, one-third of the eligible population is not up-to-date screened for colorectal cancer. In light of this, Epigenomics developed Epi proColon®, the first and only FDA-approved liquid biopsy test for colorectal cancer screening. It is a clinical laboratory procedure that uses blood specimen for the detection of a specific methylation event to identify patients with a likelihood of colorectal cancer. “Early detection of colorectal cancer can lead to prevention in the affected population. Hence, regular screening is crucial, and our technology serves as the most convenient screening method,” adds Doheny.
Analogously, for the detection of lung and liver cancers, Epigenomics has developed Epi proLung® and HCCBloodTest, similar liquid biopsy tests for targeted events. Epi proColon is currently available globally.

Regular screening is crucial, and our technology serves as the most convenient screening method

Via just a simple blood draw, this high-performing, minimally-invasive test is setting the benchmark in early cancer screening. “By leveraging our expertise in epigenetics, we aim to become a global leader in blood-based cancer detection,” affirms Doheny. Furthermore, the company also offers a comprehensive going-live guide, which has everything from documentation, training materials, reporting formats, and record-keeping templates that the client—be it a laboratory or a healthcare institution—needs in order to get started.

Talking about the firm’s inception, Doheny informs, “Epigenomics was established nearly 20 years ago when the founding members of the company realized the potential of epigenetics in cancer detection.” Epigenetic alterations which include aberrant DNA methylation have been associated with the development and progression of human cancer. Epigenomics started as a pioneer in DNA methylation, steadily exploiting the natural phenomenon with a rich source of biomarkers as its proprietary technology. Today, the company is dedicated to developing molecular diagnostic tests for cancer using its proprietary technology. “We are committed to increasing the prevention of the disease globally, through the use of epigenetic methods,” says Doheny.

The company recently received CE mark for its liquid biopsy, HCCBloodTest that aids in detecting liver cancer among patients with cirrhosis. The year ahead will witness the company initiating a prospective clinical trial on this in the U.S. for submission to the FDA. With the DNA methylation biomarker technology evolving at a rapid speed, Epigenomics will continue to improve its offerings to keep up with the pace of ever-growing technological advancements. “We are also planning on expanding our services to countries where cancer is more prevalent and subjected to sophisticated management,” concludes Doheny.

Top 10 In-Vitro Diagnostic Technology Solution Companies - 2019

Company
Epigenomics

Management
Noel Doheny, CEO

Description
Revolutionize the way of cancer diagnostics using our unique, proprietary DNA methylation biomarker technology. Epigenomics develops and commercializes patient-friendly, blood-based diagnostic tests across multiple cancer indications with high medical need. Using blood as a liquid biopsy can improve patient access to cancer screening and thereby contribute to eradicate today’s deadliest cancer types such as colorectal, liver, and lung cancer. By leveraging our product pipeline and strong intellectual property, we aim to become a global leader in blood-based cancer detection

Epigenomics News

Epigenomics–New Day Diagnostics: investment, 202307– acquisition of substantially all assets up to $12.05m plus license + milestones by New Day SIGNED

Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) and New Day Diagnostics LLC, a U.S. full-service diagnostics and CRO services company based in Knoxville, Tennessee, today entered into an agreement for the sale of substantially all of the Company’s assets. This agreement is the result of negotiations previously disclosed in the ad hoc announcement dated June 12, 2023.
Under the terms of the agreement, Epigenomics AG will transfer all patents as well as the entire biobank, and thus all of its assets within the meaning of Section 179a of the German Stock Corporation Act (AktG), to the acquirer. The agreement is subject to certain closing conditions, including the approval at the Company’s Extraordinary General Meeting.
For this purpose, the Company will convene an Extraordinary General Meeting at short notice to be held, as of now, in Berlin on September 11, 2023. This Extraordinary General Meeting will not only decide on the approval of this important agreement. It is also envisaged for the Extraordinary Meeting to pass a resolution on the corresponding amendment of the Company’s corporate purpose. The agreement will be made available on Epigenomics AG’s website as of the convening of the Extraordinary General Meeting.
As consideration for the sale, Epigenomics AG will receive a purchase price of up to USD 12.05 million, which can be broken down as follows:
> Cash payments of USD 1.8 million: USD 0.5 million on the closing date, USD 1.0 million on December 1, 2023 and USD 0.3 million on June 30, 2024.
> Further cash payments of up to USD 8.0 million contingent on the achievement of certain milestones related to Epi proColon and foremost Epi proColon “Next-Gen”.
> An interest in the acquirer of 3.0%, valued at least at USD 2.25 million.
In addition, the Company will receive royalty or earn-out payments, in the form of royalties linked to the commercialization of the “Next-Gen”-Test. These payments extend probably until October 2043, the year in which patent protection for the product is expected to expire.
Jens Ravens, Executive of Epigenomics AG, emphasizes the importance of the agreement: “The further development and commercialization of the “Next-Gen”-Test requires significant resources that we as a company can no longer provide. We are very confident that with New Day Diagnostics as an experienced partner in the U.S. and global markets, we will be able to successfully further develop the test and thus contribute to maximizing the potential value for shareholders. Therefore, we recommend all shareholders to approve the sale of significant assets to New Day Diagnostics at the upcoming Extraordinary General Meeting of the Company on September 11 in Berlin.”
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.
All relevant information on the upcoming Extraordinary General Meeting is expected to be available https://www.epigenomics.com/news-investors/general-shareholdermeeting/ from August 4, 2023.