Q4 and H1 2017 Outlook
The Company maintains its upgraded guidance for projected 2016 revenues, which are expected to increase by more than 60% over 2015. This sharp growth can be attributed to accelerated adoption of the ConfirmMDx for Prostate Cancer test by urologists in the U.S. The test's inclusion in the U.S. National Comprehensive Cancer Network (NCCN) Clinical Guidelines in Q1 2016 has facilitated successful contract negotiations with a number of new payors, leading to a significant increase in revenues. In addition, the Company believes that the recent award of a unique Category I CPT code for ConfirmMDx from the American Medical Association will streamline reimbursement from government and commercial payors, further accelerating adoption among payors and physicians.
For the acceleration of the second prostate cancer product SelectMDx, the Company has completed a health economic study for the Netherlands and data have been submitted for publication. The Company also completed a study comparing the SelectMDx test with MRI scan outcome data and intends to presents and publish these data. In preparation for the launch of MDxHealth's third product AssureMDx for bladder cancer, a multi-center clinical validation study has been completed and submitted for publication. Publication of these data is important to support a successful introduction and launch of the AssureMDx test.
MDxHealth maintains its guidance that underlying Earnings Before Interest, Taxes, Depreciation and Amortization (EBIDTA) for the year ended 2016 are expected to improve compared to 2015.
The Company continues to work towards broadening its portfolio and continues to make progress on the development of tests for the diagnosis of other indications, including kidney cancer, with the aim of providing a full suite of products for the diagnosis of urological cancers.