MDxHealth's acquisition of NovioGendix helps put CTMM research into the hands of patients
In this month’s newsletter we talk to MDxHealth's CEO, Dr Jan Groen, about the company's acquisition of NovioGendix and the recently launched SelectMDx diagnostic test for prostate cancer, which has its roots in the CTMM PCMM (Prostate Cancer Molecular Medicine) project.
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It's not unusual for university spin-off companies to be bought by larger industry players. In fact, it's often part of their initial business plan. It may also be a desirable step in getting the benefits of scientific research into the hands of those who can benefit from it. The purchase of NovioGendix by MDxHealth in September 2015 is a case in point.
Founded in 2006 as a spin-off from Radboud University Medical Centre, NovioGendix was a partner in the CTMM PCMM (Prostate Cancer Molecular Medicine) project from the outset, with its Chief Scientific Officer and founder Dr. Jack Schalken playing a key role in writing the project proposal. One of the stated aims of the PCMM project was to 'reduce over-diagnosis and over-treatment of prostate cancer due to today’s less than ideal screening tests'. To achieve it, the project aimed to develop and validate novel biomarkers in blood, urine and tissue that could be used to diagnose and evaluate prognosis for individual prostate cancer patients as a more effective alternative to existing tests.
By the end of the PCMM project in 2014, NovioGendix had successfully developed, validated and CE marked a mRNA-based urine test to identify patients at low risk for prostate cancer, and patients at risk of having high-grade prostate cancer. With MDxHealth's strong focus on urological cancers, that made NovioGendix an attractive acquisition.
Mr. Jan Groen, MDxHealth
However, as MDxHealth CEO Dr Jan Groen points out, developing a test with the necessary sensitivity and specificity is not the only necessary requirement to bring a product to the market. Several things have to be right in order to implement an effective go-to-market strategy, the foremost being a compelling clinical benefit.
"For patients with elevated levels of prostate-specific antigen in their blood, the standard of care across the world is to take 10 to 12 biopsy samples from their prostate and send them off to a pathology lab for histological analysis. However, around 60% to 70% of men turn out to be negative for prostate cancer based on their histology results, despite the fact that they have an increased PSA level or other clinical manifestations that could be indicative for prostate cancer," explains Jan.
"The beauty of NovioGendix's test, which we've rebranded as SelectMDx, is that it's designed to be used before the decision is made to perform a biopsy, giving physicians a 'risk score' that reflects the likelihood of the patient proving positive for prostate cancer. The patient and his physician can then incorporate that risk score into their decision making, because prostate biopsies are not only invasive and uncomfortable, but can also have side effects."
In addition to clinical benefits, a successful test also has to offer financial benefits.
"When tested, a large proportion of men have blood PSA levels between 3 ng/ml and 10 ng/ml, in which case the decision to recommend a biopsy is largely based on their urologist's knowledge and experience. Above 10 ng/ml they will immediately start intervening with biopsy or something else, and below 3 ng/ml they typically just recommend a follow-up PSA test after a year or so. So we are targeting the SelectMDx test at patients with PSA levels of 3 ng/ml to 10 ng/ml," says Jan.
"With SelectMDx we can stratify that group into men who are likely to have high-grade cancer, and those likely to have a low-grade cancer that doesn't warrant a biopsy. Based on clinical trials, it means that around 25% to 30% of the biopsies currently performed could be avoided, which at a current cost in the US of between $3000 and $5000 per biopsy is a significant cost saving."
However, according to Jan, the financial incentives to using SelectMDx are not only limited to cost savings.
"The SelectMDx test requires a slight two-finger squeeze on the prostate to force a small amount of prostatic fluid into the urethra and transfer more of the relevant cellular material into it before the urine sample is collected. In the US, a medical procedure such as this is covered by an existing reimbursement code. This makes SelectMDx an attractive test for them compared to a blood-based test. For a blood-based test, the majority of community-based urologists have to send their patients to a blood drawing station. They are therefore not in control of the sample and they do not benefit from any reimbursement for such a procedure."
It was this combination of clinical benefit, financial benefit and market size that made NovioGendix an attractive acquisition for MDxHealth, but there is one other thing that Jan considers when he looks at prospective acquisitions.
"I look for companies with late-stage products that are well supported by scientific publications. When you start talking to payers such as health insurers, the first thing they ask for is clinical data and publications in peer reviewed journals. Thanks to the hard work put in by the CTMM PCMM consortium and the NovioGendix team in Nijmegen, these data and publications were already in place."