Q&A with Bradford Moose LeukoLifeDx

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.

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.

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.