NEW YORK (GenomeWeb) – MDxHealth reported Thursday that its total full-year 2017 revenues rose 35 percent, led by sales of its ConfirmMDx for prostate cancer test, which accounted for 91 percent of sales volumes.
For the 12 months ended Dec. 31, the company reported total revenues of $40.5 million, up from $30.0 million in 2016. Revenue included the sale of the company's colorectal cancer patents to Exact Sciences. Excluding revenue from that sale for both periods, total products and services revenue rose approximately 13 percent to $28.2 million during 2017.
Total US testing volume for ConfirmMDx, which is meant to address false-negative biopsy concerns, grew to 21,400 in 2017 from 20,400 in 2016. Total test volume in the fourth quarter grew 14 percent to 6,400 from 5,600 in Q4 2016. Global test volume for the firm's SelectMDx for prostate cancer test, which helps identify patients at increased risk for aggressive disease, grew to 11,700 in 2017 from 4,000 in 2016. Test volume in Europe rose more than 300 percent to more than 3,100 patients tested compared to 800 in 2016.
ConfirmMDx remained MDxHealth's lead product and accounted for 91 percent of product and services revenues. However, its growth was hampered by delays in the fourth quarter in obtaining billable cases from contracted customers and from a large post-marketing study, reducing its contribution to sales from 97 percent in 2016. Test volumes for SelectMDx accounted for 35 percent of total product sales volumes.
The company also noted that it signed 20 new US payor contracts for ConfirmMDx during the year, including with the US General Services Administration, Kaiser Southern California Permanent Medical Group, 10 out of 36 Blue Cross Blue Shield Association affiliated plans, and several Medicaid programs, bringing the total number of contracted payors to 62. It also signed four new US payor contracts for SelectMDx.
MDxHealth also rolled out its third commercial test in the US in 2017 — AssureMDx for Bladder Cancer, a liquid biopsy laboratory developed test to assess the risk of bladder cancer for patients diagnosed with hematuria.
"We remain confident in the potential of ConfirmMDx, which we expect to continue driving momentum in the mid-term and for which we have a renewed approach aimed at capturing additional market share," MDxHealth CEO Jan Groen said in a statement. "In the longer term, we expect SelectMDx to continue driving growth with numerous value-driving inflection points in the coming years. We are positive about the outlook for the current year. We believe MDxHealth can achieve a higher level of product and services revenue growth than in 2017."
On a conference call with investment analysts following the release of the earnings, Groen added that the company is planning to apply for Medicare coverage of SelectMDx in 2018, and hopes to receive a positive coverage decision late in 2018 or early in 2019.
He also noted that MDxHealth is working on expanding the indication for SelectMDx to include active monitoring of a patient's prostate cancer. The firm has completed two studies on the test's ability to perform this function, and Groen said the indication will be updated once those results are published.
The firm's net loss for 2017 narrowed to $12.3 million, or $.25 per share, from $13.2 million, or $.26 per share, in 2016.
MDxHealth ended the year with $16.8 million in cash and cash equivalents.
On the call, Groen noted that the firm is looking to develop its test pipeline in 2018, including working with pharmaceutical companies to develop companion diagnostics. MDxHealth is targeting drug companies working on treatments for urological cancers for these collaborations, but it does not plan on venturing into other cancers, he added.