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Home : Medical Device Daily : March 21, 2016 : Article
LIQUID BIOPSY GOLD RUSH
MDxhealth aims to disrupt U.S. prostate market for biopsy, MRI exams
By John Brosky
Contributing Writer
PARIS — Moving rapidly to hold a first-mover momentum in the fast-breaking space for liquid biopsy, MDxhealth SA, of Herstal, Belgium, announced it is launching in the United States as a laboratory developed test (LDT) its SelectMDx assay for prostate cancer.
Just six months after acquiring the test, MDxhealth has established a 37-strong U.S. sales force, set up a lab facility ready to process samples in California, and concluded a clinical study now heading for publication.
Using SelectMDx with a simple urine sample, the 4.7 million American men who each year test positive for elevated levels of prostate-specific antigen (PSA) could learn if they have a life-threatening form of prostate cancer or not.
With a negative predictive value of 98 percent for detecting high-grade cancers, SelectMDx effectively is able to prove the opposite, assuring a urologist a specific patient has a very low risk for clinically significant cancer and thereby improving patient stratification.
The SelectMDx liquid biopsy test is poised to disrupt the current standards of care for surgical biopsies costing $3,000 and MRI exams costing an average of $5,000 with a urine sample taken in the urologist's office.
More than 1.3 million prostate biopsy procedures are performed each year in the U.S. and MDxhealth estimates the total addressable market in the U.S. for prostate cancer tests to be $1.7 billion.
"Moving forward, liquid biopsy will certainly win market share not only because of the ease-of-use from a collection standpoint, but because we now have technologies that are more sensitive and specific to accurately detect and grade cancers, that are able to extract more information in these liquid samples," MDxhealth CEO Jan Groen told Medical Device Daily.
In the pre-biopsy evaluation segment of the prostate market, MDxhealth faces competition for liquid biopsy from two blood-draw assays that require a patient to be sent to a phlebotomist, the 4Kscore test from Miami-based Opko Health Inc, and the Prostate Health Index from Brea, Calif.-based Beckman Coulter Inc.
MDxhealth secured the SelectMDx assay with the acquisition of the start-up Noviogendix Holding BV, of Nijmegen, Netherlands, in a $8.8 million deal where half the value was paid through a stock swap and the remainder is due through performance milestones (Medical Device Daily, Sept. 17, 2015).
"It didn't cost us a penny," said Groen.
"This purchase gave us a validated test in hand with no royalties to pay and with no further development risk, and a test we could offer right away as an LDT service," he said.
Unusually, Groen focused immediately on a commercial launch for the United States, passing by the well-traveled path to market through an initial European roll-out for the test, which holds CE mark approval.
LDT assays, also known as home-brew diagnostic tests, do not require scrutiny from the FDA as they are offered as a service from the laboratory for urologists nationwide.
"We have heavily invested in a sales structure for the U.S. with 33 representatives on-the-ground and four sales managers," said Groen, who added that much of the company's clinical work and studies have been done with research and academic centers in the U.S.
"From a health care perspective the U.S. rewards innovation," he said. "And the country presents a more uniform market for guidelines, for reimbursement and in general speaks one language. In Europe we have to deal with a diverse mix of countries with a mixed set of guidelines and reimbursement."
He said that prior to the acquisition of Noviogendix, MDxhealth was a pure Belgian play with a business model of licensing out the epigenetic molecular diagnostic assays it had acquired, significantly a methylation-specific polymerase chain reaction (PCR) technology in a licensing deal with The Johns Hopkins University in Baltimore, Md.
Currently in the U.S. the company's Cologuard test for colon cancer is sold by Madison, Wis.-based Exact Sciences Corp. and its PredictMDx test for glioblastoma tumors in the brain is offered by Laboratory Corporation of America Holdings, based in Burlington, N.C.
"With the acquisition of Noviogendix, we took a first step of becoming an IVD [in vitro diagnostics] company that is a sales channel and outsources its manufacturing," Groen said.
In 2015, MDxhealth reported revenue of $17.6 million, an increase of 51 percent over 2014, of which 86 percent was generated by its ConfimMDx testing of post-biopsy prostate tissue samples. While the total value of ConfimMDx tests ran to $36 million in 2015, only $15.2 million was recognized as revenue with the balance carried over to 2016 as outstanding billings to Medicare and private U.S. insurers.
The Company ended 2015 with $31.7 million in cash, thanks to $29.5 million raised in a private placement in June, 2015. Groen said cash burn has been tightened to $1.4 million per month.
Medicare reimburses the ConfimMDx prostate test and it is included in the National Comprehensive Cancer Network (NCCN) guidelines.
Groen said the SelectMDx is on a path to achieve these two key milestones as well.
In March 2016, at the Congress of the European Association of Urology, MDxhealth presented positive results from a prospective, multicenter validation study of SelectMDx, and Groen said a publication of the findings in a professional journal will follow.
The clinical development program includes a second multi-center study for the U.S., health economic studies and validation of clinical utility.
Where he estimated the addressable post-biopsy market for the ConfirmMDx test at 700,000 patients annually, he believes one million men annually is the population to be served with the SelectMDX in pre-biopsy evaluation.
The business model for the U.S. will remain a lab service model, where in Europe Groen said SelectMDx will be offered as an IVD kit for hospital labs to perform the testing, likely in a few months from now.
"In the U.S. two-thirds of all clinical specimens coming from hospitals are outsourced to commercial entities. In Europe this service testing model does not exist anywhere near the same level because almost all hospitals have their own labs," he said.
Medical Device Daily March 21, 2016
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