Liver cancer is one of the most common types of cancer worldwide, with over 840,000 new cases diagnosed each year. Without early detection and treatment, liver cancer can be deadly. Currently, there are limited options for detecting liver cancer in its early stages, making it a challenging disease to manage.
Epigenomics' liquid biopsy test offers a non-invasive option for detecting liver cancer early. The test is based on the detection of methylated DNA fragments in the blood, which are characteristic of liver cancer cells. Using cutting-edge technology, the test can detect even small amounts of these DNA fragments, making it highly accurate.
Now that the test has obtained the CE Mark, it can be commercialized in Europe, providing physicians and patients with a powerful tool for the early detection of liver cancer. This is a significant milestone for the company and for liver cancer patients around the world.
In addition to the CE Mark, Epigenomics is also planning to initiate a prospective clinical trial in the United States in 2019. The trial will gather data on the performance of the liquid biopsy test and will be used to support a submission to the U.S. Food and Drug Administration (FDA) for regulatory approval.
The company is also exploring options for obtaining approval from the China Food and Drug Administration (CFDA), which would allow it to market the test in China. This is an important market for liver cancer detection, as China has a high incidence of the disease.
Epigenomics' CEO, Dr. Thomas Taapken, commented on the news, saying: "The CE Mark for our liquid biopsy test for liver cancer detection is an important achievement for Epigenomics. This certification allows us to move forward with commercialization in Europe and provides physicians with a valuable tool for early detection of this deadly disease. We look forward to continuing to advance the development of this important technology and to bringing it to patients around the world."
Xiamen Baysen Medical Tech Co., Ltd. is partnering with Epigenomics to commercialize the test in China. The company is a leader in the development of fast diagnostic reagents and is committed to providing high-quality products to the healthcare industry.
With the CE Mark and upcoming clinical trial in the United States, Epigenomics is well-positioned to become a major player in the fight against liver cancer. The liquid biopsy test offers a non-invasive, highly accurate option for detecting the disease in its early stages, giving patients and physicians the best possible chance for successful treatment. The company is poised to make a significant impact on the field of cancer diagnosis and treatment, and we look forward to seeing its continued success.