Lynx Dx is a company on a mission to improve patient care through science-based and best-in-class technology. The company was originally founded in 2015 by a group of credentialed and renowned clinical leaders from the University of Michigan’s urology department with the goal of treating prostate cancer patients and improving prostate cancer screening. Pulse 2.0 interviewed Lynx Dx Chief Medical and Commercial Officer Spencer Heaton, MD, MBA, to learn more about the company.
Dr. Heaton’s Background
What is Dr. Heaton’s background? Dr. Heaton is a physician with board certification in anesthesiology and pain medicine. And Dr. Heaton said:
“I also received an MBA from the University of Michigan’s Ross School of Business. For about a decade I have worked in various healthcare companies ranging from healthcare IT, device/diagnostics development, and drug discovery and development.”
“I oversee cross-functional collaborative projects that aim to translate scientific discoveries into user-friendly products that are accessible and affordable for patients. There are a lot of barriers to getting great scientific discoveries into patient care, and I work to overcome those barriers.”
Favorite Memory
What has been Dr. Heaton’s favorite memory working for Lynx Dx so far? Dr. Heaton reflected:
“At Lynx Dx, we are swinging for the fences to change the standard of care in prostate cancer screening and diagnosis, which historically is a very challenging task to do efficiently. Men with an elevated PSA are known to be at higher risk of prostate cancer, but most do not have clinically significant prostate cancer (the type of prostate cancer that requires treatment). My favorite memory of working at Lynx Dx is actually a recurring event – I really enjoy our strategic R&D and planning meetings where great minds come together to work out elegant solutions to complicated problems. We do that very well here, and I love being a part of that process.”
Core Products
What are Lynx Dx’s core products and features? Dr. Heaton explained:
“Our core product is MyProstateScore 2.0 (MPS2), which answers a very complicated question with a simple urine sample. The test analyzes the transcripts in the urine from 18 genes in the context of clinical risk factors (e.g., race, family history, abnormal digital rectal exam findings, age) when available to generate a personalized risk score for each patient. The MPS2 result is reported as a percentage risk that your urologist will find clinically significant prostate cancer if you have a biopsy. As you can imagine, that MPS2 result provides very helpful insights that guide the decision whether to undergo a biopsy for men with an elevated PSA.”
“The clinical validation paper for MPS2 was recently published in JAMA Oncology, and sets MPS2 apart as the next generation biomarker test for prostate cancer risk prediction.”
Challenges Faced
What challenges has Dr. Heaton faced in his line of work recently? Dr. Heaton acknowledged:
“Our goals are to first develop the most scientifically sound reliable biomarker tests and second to make those tests available and accessible to as many patients as possible. You would think that the research and science behind the development of a test is the greatest challenge for companies like ours, but in reality, the bigger challenge is facilitating patient access.”
“Securing insurance coverage for tests like ours can feel like hand-to-hand combat and the process requires a dedicated team working around the clock with insurance payers around the country. We are making rapid progress in these areas and are excited that we will have even greater patient access this year.”
Evolution Of Lynx Dx’s Technology
How has Lynx Dx’s technology evolved since launching? Dr. Heaton noted:
“Lynx Dx was originally founded to commercialize the first-generation test called MyProstateScore (MPS), which is a urine-based test that analyzes 2 urine biomarkers along with serum PSA to predict the risk of clinically significant prostate cancer. Although MPS was developed through excellent research, the team felt there was an opportunity to really move the needle in prostate cancer diagnostics by developing a test based on the discovery of additional high-grade cancer markers, leading to the development of the 18-gene MPS2 test.”
“Future developments will expand the use cases for urine biomarker testing into monitoring cancer progression and recurrence after treatment.”
Significant Milestones
What have been some of the company’s most significant milestones? Dr. Heaton cited:
“The most significant milestone for the company occurred just last month when the clinical validation paper for MPS2 was published in JAMA Oncology. That publication represents years of research at the University of Michigan, with whom we are partnered.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Dr. Heaton assessed:
“Current estimated US addressable market for prostate cancer is about $3 billion. There is very little revenue in the current market for biomarker testing. Future state estimates for biomarker testing (pre-biopsy) for prostate cancer are very large at approximately $1.5 billion.”
Differentiation From The Competition
What differentiates the company from its competition? Dr. Heaton affirmed:
“Lynx Dx is a very nimble company with a strong relationship with the University of Michigan that allows access to world-class research. We have a proven track record of solving challenging problems with teams of great people.”
“What differentiates our lead product is that compared to other tests currently available, which rely on a few biomarkers, MPS2 has been developed with a comprehensive array of 18 biomarkers that represent the next generation in prostate cancer risk prediction. Among the 18 markers are some that are specific to high-grade cancer detection, which significantly improves the accuracy of MPS2 as a rule-out test for high-grade cancer.”
“The benefit of this comprehensive array of biomarkers is particularly evident in patients who have already had a prostate biopsy in the past that was negative, but now their PSA is creeping up and they are being considered for another biopsy. This patient population can be very challenging and historically biomarker tests have struggled to perform well in this setting. But, this is where MPS2 shines, having a Negative Predictive Value of 99% in men with a prior negative biopsy. This means that if you have a low risk MPS2 result, the likelihood that you do not have clinically significant prostate cancer is 99%. This is the first biomarker test with 99% Negative Predictive Value in this difficult-to-manage population of men with a prior negative biopsy.”
Future Company Goals
What are some of the company’s future company goals? Dr. Heaton concluded:
“There is a lot of work to do to optimize prostate cancer screening and diagnosis. In addition to continual improvements in our core MPS2 product line, we are also working on biomarker tests that will enable patients on Active Surveillance (a process through which patients with indolent prostate cancer are monitored over time) to better understand when they may require additional testing to determine if their cancer has progressed to a form that should be treated instead of monitored.”
