Q&A with Bradford Moose LeukoLifeDx
Heart Disease and its end-stage Heart Failure is the number 1 cause of death, affecting 92 million people and killing 600,000 patients per year in the US. 20% of patients who undergo Heart Failure surgery, some 240,000 annually, die within one year of such procedures, receiving no survival benefit.
LeukoLifeDx is a medical diagnostic company using gene expression profiling to guide the treatment of Heart Failure by providing quantitative survival outcome data. By identifying these high-risk patients, our new genomic assay will allow cardiologists to direct predicted survivors to surgery and predicted non-survivors to medical therapy, saving 80,000 patients and $3 billion in healthcare costs per year.
LeukoLifeDx was founded 3 years ago by 1) a family with medical and business expertise who was deeply affected by Heart Failure and would have lost a family member except for the heart transplant that saved her life, and 2) the scientific and medical team that guided her care.
With proof-of-concept data showing 96% accuracy, an issued US patent, and enthusiastic endorsement from cardiologists, we are ready to conduct a 500-patient clinical study to validate the assay for launch in 2023.
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Why is this problem of high mortality following Heart Failure surgery so important?
We tend to underestimate the impact of common widespread risks as compared to sudden, unexpected risks that may impact fewer people. COVID-19 for instance has killed more than 130,000 people in the US in the last 6 months and is appropriately a worldwide and national priority public health crisis that deserves our full attention. But we also need to remember that Heart Disease / Heart Failure routinely kills 600,000 every year, and cancer kills nearly as many.
It is both the magnitude of the impact that Heart Failure has year-after-year on our society and the cost that make it a huge problem. It is also tragic that while we have developed incredible technology for treating the disease, we still lose 240,000 patients each year because they are not well enough to survive one of these surgical / interventional therapies, and we cannot identify these high-risk patients who should stay on medical therapy in advance.
Most importantly, the wide view of the impact of Heart Failure on society, does not adequately represent the devastating loss that families feel when the statistic that raises the death toll from Heart Disease is the loss of a loved-one. For a family that has experienced the life-threatening impact of this disease, an innovation that promises to save more patients, and may save your family member, is the most compelling goal that a company and its founders could have.
Why has no one explored the innovative use of genomics in treating Heart Failure before LeukoLifeDx?
We believe that like many other disruptive innovations, the timing is right for our use of genomics in Heart Failure because the need is obvious and the technology is proven, but no one has yet applied it to the problem we are addressing.
Genomic assays to guide medical therapy have been used for more than a decade in cancer therapy and organ transplant rejection with such success that they are now considered standard-of-care and reimbursed by CMS and private insurance.
We believe that gene expression profiling is a stepping-stone to the advancement of personalized medicine, where the treatment selected by the physician is the one that diagnostic assays indicate will be most effective and most likely to extend the patient’s life. Our prediction is that in the future a great many therapeutic options for a variety of medical conditions will be selected based on the gene expression of the patient, at the time treatment options are being considered, used as a guide to individual response and the predicted success of the treatment.
What could go wrong that would undermine the company’s projected growth and success?
Several key risks remain for our business and the success of our first product. First, while we have excellent proof-of-concept data in a small patient population, it is possible that the larger study we need to conduct prior to launching the product may not yield data showing the same accurate predictive value as the shown by the current studies.
Second, while cardiologists have confirmed the need for more accurate quantitative survival outcome prediction, even with positive data from a larger clinical trial, these physicians may be reluctant to order the assay in the routine treatment decisions related to their Heart Failure patients.
Third, even if physicians order the test, insurers may not provide reimbursement coverage as soon as we predict, by considering the assay to be experimental rather than standard-of-care.
Based on the data we have on each of these issues, we consider these risks to be small, with the potential benefit to patients, physicians, hospitals, insurers, and investors greater than the risks and obvious to those knowledgeable in the field.
Bradford Moose LeukoLifeDx
Brad Moose, MBA, founder, consultant and COO, is an operations and finance executive with 20 years’ experience in a variety of consumer product and FDA-regulated industries. He has successfully led businesses through periods of dramatic scale increases and liquidity events, helping to create substantial shareholder value. His initiatives and application of best business practices have resulted in $multi-million savings across companies as diverse as Roche, M&M Mars, L’Oreal, and Bai Brands. Brad has played an integral role in developing the Leukolife business plan and financial model.
Contact Brad: email@example.com