MDxHealth ($MDXH) is using epigenetic markers to develop diagnostic tests for cancer, with ConfirmMDx products to assess the presence or absence of cancer, InformMDx products to distinguish between aggressive and non-aggressive cancers and forecast the risk of recurrence, and PredictMDx products to decide which treatments are most likely to be effective.
Epigenetic changes are inherited changes to the DNA molecules that don't affect the actual sequence of the DNA, and have been described as "Post-it Notes" on genes. Epigenetic changes, including the addition of methyl groups, switch genes on or off. Their presence or absence could help with early diagnosis, or could indicate disease that is more likely to progress quickly. For example, the lack of methylation on DNA in skin cells could track the shift from healthy skin cells to melanoma. Epigenetic changes could also be used in personalized medicine to select the patients who are more or less likely to respond to particular drugs.
MDxHealth's ConfirmMDx for Prostate Cancer is on the market and is designed to confirm the results of negative prostate biopsies in men who have rising levels of PSA (prostate-specific antigen), reducing the need for unpleasant and invasive repeat tests. It can also be used to guide treatment in the 25% of men whose biopsies come up negative but have hidden cancers.
MDxHealth is also developing ConfirmMDx for Lung Cancer, InformMDx for Lung Cancer, and InformMDx for Colon Cancer. Merck KGaA has an agreement in place with MDxHealth to use the diagnostic company's PredictMDx test as a companion diagnostic to select those glioblastoma patients who might benefit from Merck KGaA's investigative drug cilengitide. PredictMDx looks for methylation of the MGMT gene promoter. MDxHealth also has an agreement with GlaxoSmithKline ($GSK) for companion diagnostic tests for GSK's immunotherapeutic oncology program.