The diagnostics game has changed dramatically over the past 15 years. Old-school companies placed their bets on high-volume, low-margin tests, but today’s molecular diagnostics players are all about value proposition. The market is hungry for simple tests that impact patient outcomes while also taking costs out of the system.
One up-and-coming company in the space that seems to understand that concept particularly well is Jupiter, Fla.-based MDNA Life Sciences Inc.
The company is already generating revenue with its Prostate Core Mitomic Test, a tissue-based prostate cancer diagnostic based on mitrochondrial DNA. Now MDNA is on the verge of launching a slew of blood-based tests that leverage 15-years of research and development and biomarkers for disease categories that, like prostate cancer, still depend on poor screening methods or invasive diagnostic procedures such as biopsies or surgery.
MDNA expects to launch its blood-based Prostate Mitomic Test in the second quarter of 2016, followed by the launch of its Endometriosis Mitomic Test in the fourth quarter. The company is also developing blood-based tests for ovarian and lung cancer, which are slated for market launch in the second and fourth quarters of 2017, respectively. The company will also continue to sell its tissue-based prostate test. Looking even farther into the company’s future, MDNA plans to pursue monitoring applications to help guide post-diagnosis treatment decisions.
To usher the firm into this new phase of commercialization, MDNA brought in two new executives earlier this year, CEO Chris Mitton and CFO Jack Riccardi.
The company’s platform is based on the knowledge that within mitochondrial DNA there are disease-specific mutations and deletions that occur very early and, because there are thousands of mitochondria in each cell, the target is abundant in a blood sample, Mitton told Medical Device Daily.
With 15-plus years of research and development under its belt, he said the company is now ready to leverage that technology to develop a platform of simple, cost-effective tests that can be plugged into a commercial CLIA lab and fit into a typical molecular workflow on a real-time PCR platform.
“In terms of market access and adoption, it’s developed in a format that enables rapid uptake,” Mitton said.
Going after the prostate
MDNA estimated that the molecular diagnostics opportunity in prostate cancer is $1.47 billion. The company’s tissue based prostate cancer test is being marketed as a reflex to a negative biopsy, Mitton said. He noted that in prostate cancer, 70 percent of biopsy results are negative and about half of those are false negatives. The Prostate Core Mitomic Test was developed to help patients and doctors determine whether or not to do a repeat biopsy.
One comparable test on the market is Confirmmdx from Irvine, Calif.-based Mdxhealth Inc., which is based on the company’s DNA methylation (epigenetic) technology and designed to help physicians with the diagnosis of cancer, prognosis of recurrence risk and prediction of response to a specific therapy.
According to MDNA, the tissue-based Prostate Core Mitomic Test has been shown to identify 85 percent of prostate tumors missed by biopsy compared to the 68 percent sensitivity of the Confirmmdx test.
MDNA’s blood-based test has the potential to have an even bigger clinical impact because it can be used earlier in the screening process and the addressable market is larger.
“We’re addressing that same clinical dilemma earlier. We’re able to do that because these biomarkers show up so early in these healthy cells,” Mitton said. “We’re seeing these deletions before a lot of other clinical evidence is even present.”
The company has processed more than 50,000 samples with its tissue-based prostate test and that product has been well received by the market, Mitton said.
The endometriosis opportunity
The company’s second blood-based test is designed to address another significant clinical problem, this time for endometriosis, a painful chronic disorder that affects an estimated 6.3 million U.S. and Canadian females, and millions more worldwide, according to the Endometriosis Association.
“At this point we have nothing in terms of non-invasive diagnostic tools to help triage that,” Mitton said. “We rely on laparoscopic surgery and the road to diagnoses for women usually takes eight to 10 years.”
That’s because the key symptoms of that condition, pain and bleeding, can be vague and intermittent. MDNA estimated that the market opportunity for its blood-based endometriosis test is in the ballpark of $660 million.
Deeper in the pipeline
MDNA plans to follow the prostate cancer and endometriosis blood tests with ovarian and lung cancer tests, representing $1.7 billion and $2.28 billion market opportunities, respectively. Eventually, the company expects to broaden its reach into monitoring applications to help guide post-diagnoses treatment decisions. Other potential applications include cardiovascular disease, central nervous system disorders, endocrinology, and dermatology.
“These simple blood-based tests are really something that the market is asking for and we have a platform that can deliver not only those two, but a slew of other tests in our pipeline,” Mitton said.
MDNA has completed proof-of-concept studies and biomarker selection for 11 different categories across multiple disease states, he said.
Market hurdles
Mitton said the company’s key challenge to date has been securing enough funding to support its product development plans, although he said the company is backed by high net worth investors who continue to reinvest.
From a commercial standpoint, MDNA operates with a lean management team and its strategy is not to build out its own CLIA lab or direct sales force but to instead partner with commercial labs that already have the necessary infrastructure and industry relationships to add these new tests to an existing menu.
To demonstrate the platform’s value proposition, Mitton said MDNA has processed more than 50,000 samples with its initial product, the tissue-based prostate cancer test, and he said the test has been well received by the market.
Building a clinical value case is a key part of securing reimbursement for a new test and Mitton said the tissue test is currently being reimbursed by several private players. The company is also working on a Medicare package to try to unlock a backlog of roughly 3.4 million Medicare claims.
The company has demonstrated that its test decreases repeat biopsies by ten-fold when the test result is negative. “The negative predictive value is off the charts,” Mitton said. “When you have a positive prostate tissue test we’ve demonstrated that we advance repeat biopsy by two and a half months. So that means we’re getting to a diagnoses sooner, getting to a treatment decision sooner and impacting outcomes and health care costs as well.”
One aspect of the business that MDNA is most confident about is the anticipated market adoption of its blood-based tests.
“The pathology labs in this business are eager to have this novel content. At this point, we kind of have to choose which ones we want to work with based on their capabilities from a commercial standpoint, their relationships, the size of their sales organization, their internal processes and the lab itself,” Mitton said.