A new gene-based test for prostate cancer may reduce the need to repeat painful biopsies that can also cause serious infections, according to a study to be published in the Journal of Urology.
The ConfirmMDx test, sold by MDxHealth SA and based on technology developed at Johns Hopkins University, examined samples from biopsies and confirmed whether a patient was clear of cancer with 90 percent accuracy, according to the study of 498 men who underwent a second biopsy within 30 months. The findings will appear in the November issue of the journal, according to the Liege, Belgium-based company.
The results’ publication should help attract the attention of physicians and drive both revenue and reimbursement from health insurers, said Rudi Marien, managing director of Biovest NV, which holds 15 percent of MDxHealth shares. Sales began in May and are so far in line with company expectations, Chief Executive Officer Jan Groen said in an interview. At least a quarter of negative biopsy results are false negatives, prompting patients to repeat the sometimes risky procedure.
“It’s not a small thing to subject a patient to a second biopsy,” said Eric Wallen, a professor of urology at the University of North Carolina who began using the test three months ago. With a negative result from ConfirmMDx, “I can reassure patients that I’ve got a test here that tells me I can be quite confident that there isn’t a cancer hiding that I missed.”
MDxHealth shares have gained 34 percent this year. The Belgian company funded the study.
About 1.5 million men get abnormal results from so-called PSA tests annually in the U.S., leading to more than 900,000 biopsies a year, according to Michael King, an analyst at Nomura Code Securities Ltd. in London. The procedure involves passing a needle through the rectum and into the prostate gland to take eight to 12 tissue samples.
About one in 200 men who undergo a prostate biopsy will develop a serious infection or report trouble urinating, researchers said in a scientific review published last year in the Annals of Internal Medicine. The 15-minute test carries an infection risk because the needle can take bacteria from the bowel into the prostate, bladder and bloodstream.
MDxHealth’s test analyzes biopsy samples to determine whether some genes such as those that suppress tumors are switched off, a process that’s associated with the presence or development of most cancers.
The product will compete with a test from Mitomics Inc., which the Thunder Bay, Ontario-based company says can rule out cancer with 91 percent accuracy. Epigenomics AG, based in Berlin, uses a similar approach in tests to detect colon and lung cancers, which are marketed in Europe. A colon cancer test awaits U.S. regulatory approval.
ConfirmMDx may help insurers save money by cutting the number of unnecessary biopsies, according to CEO Groen. The procedure costs about $2,500, whereas Nomura Code’s King estimates the price of the test at about $146 per tissue sample. MDxHealth says it is only targeting urologists in the U.S., given the size of the market and the fact that European countries each have distinct procedures for reimbursement.
MDxHealth has also partnered with drugmakers such as GlaxoSmithKline Plc of London and Whitehouse Station, New Jersey-based Merck & Co. on diagnostics that help determine whether patients respond to the companies’ cancer treatments.
Sales of those tests and the introduction of ConfirmMDx pushed up sales 43 percent to 2.01 million euros ($2.59 million) in the six months ended June 30. MDxHealth may report a profit in 2014, according to Nomura Code.
The company says it’s also developing a version of ConfirmMDx for lung cancer. A second test in the works could help distinguish between aggressive and slow-growth cancers.
“MDxHealth’s diagnostic technology has the potential to be used in a wide number of cancer applications,” Nomura’s King said. “The publication will certainly help the company convince urologists.”