Geneticure for Hypertension

Chronic diseases like Hypertension are costly ($94B in the U.S annually), dangerous (as organ damage begins to occur immediately), and hard to treat. The average 7-8mmHg drop in blood pressure when a medication is administered is only seen in 50% of the population while each of these medications have dramatic side effects. When these initial medications do not result in achieving blood pressure targets, the current standard of care recommends adding additional medication. As medications are added and dosages titrated, many visits are required & patients are often taking unnecessary medications that have long-term side effects. Trial-and-error of layering medications is not desirable. Side effects aren’t the only disadvantage to the layering of medication. For each medication added to a patient’s regimen, there is a 70% increase in non-compliance. These factors lead to 50% control rates for the leading preventable cause of death in the world. Geneticure’s tests examine a series of genetic variants that determine which of the treatment options will work best for each unique patient, unique to each disease. Our patented tests go well beyond others in the pharmacogenomics field focusing on drug metabolism, which is meaningless for complex diseases driven by the genetics of integrative physiology. A simple cheek swab is sent to our CLIA-certified reference laboratory for genotyping. 3 Geneticure clinical trials and 100s of independent, peer-reviewed research have contributed to the selection and weighting of the variants most important in blood pressure treatment response. Our proprietary algorithm analyzes these results and provides a summary of ranked treatment recommendations allowing providers to take in the necessary multiple variables of a patient’s healthcare and select the prescription that is most likely to work right away. The Geneticure for hypertension solution has demonstrated the potential for meaningful improvements in outcomes (36% lower blood pressure vs. standard of care) and significant reductions spending (47% less expensive). Geneticure has additional chronic disease solutions in development with Mayo Clinic and Medtronic. As patients continue to demand convenient and cost-effective solutions, we align those needs with health systems and payers. Geneticure can be seamlessly integrated into provider practice and employer group programs. Off-the-shelf kits are ready to use or efficiently delivered by mail. Provided with the kits are instructions on how to use and how to conveniently activate the kit using a secure patient and provider portal. Reports are delivered electronically with the opportunity of integration into an EMR system. Our published evidence has shown payers receive a 16X return on investment from our $249 test, within 3 years. This is equivalent to $1,331 in savings per patient per year and 47% less expensive than standard of care, as published in the Journal of Medical Economics. Patients and employers who are increasingly on the hook for healthcare spending will benefit from the same cost reductions in addition to fewer days of missed work for visits titrating and stacking ineffective medications. Providers will benefit from new open office visits, freeing time for higher quality care and alleviating physician burnout. Our tests provide the guidance provider organizations need to achieve chronic disease management goals. Chronic diseases compete for patient attention, urgency and prescription adherence. Patients and loved-ones are attracted to our value proposition of fewer trips to their primary care provider’s office and lowering their deadly blood pressure quicker with fewer medications. Our value proposition also includes improving overall prescription adherence by optimizing for only effective medications based on the patient’s unique genetics, thereby eliminating the current practice of layering medications. This allows for additional attention to competing diseases. Geneticure has demonstrated that blood pressure in patients who used hypertension medications recommended by Geneticure was approximately 36 percent lower than in patients who were prescribed HTN medication that did not align with the Geneticure recommendation. This is equivalent to a 40% risk reduction in deadly events like heart attack and stroke. This groundbreaking research was published in the February 2019 issue of the Journal of Clinical Medicine. We have completed 3 clinical trials totaling 684 subjects leading to 5 peer-reviewed publications and 13 presentations at scientific conferences. Our studies have shown a control rate of 97% within 6 months, with fewer medications and 43% less adverse events vs. the standard of care.

Health Systems, Employers, Pharmacy

Clinically there has been no other option, so it's natural to think the current way of doing things is 'fine.' If you invert, and Geneticure and standard of care were both available, there is much less doubt. There most certainly is a problem with how we prescribe medications, and population-wide results from the standard of care are pretty dismal[1, 2]. There have been minimal meaningful advances in HTN care in recent years, and this has led to complacency with the standard of care. Despite the perception that current time to control the disease is good, control rates are abysmal, and that is extremely costly ($94B annually in the U.S.). End organ damage begins to occur immediately with high BP. 40% of patients on meds and taking medications as prescribed by their clinician (confirmed with urine testing and mass spectrometry) are not under control[3], they are on the wrong therapy. Additionally, even if patients achieve their blood pressure goal in 6-8mo, patients are very often taking unnecessary medications for life that have long term side effects or some that may cause blood pressure to go up. There is a very under-appreciated bell-curve (variable) response to BP therapy. 40-50% of patients respond to each medication, even when adherence is confirmed. Meaning, this is not due to lack of compliance. The average reduction in BP for any medication is 7-8mmHg over the placebo effect, and each medication class has dramatic side effects[4] [5] [6, 7]. Because of this, layering of medications that may or may not work will not be a best clinical practice in the future: for each medication added to a patient's regimen, there is a 70% increase in non-compliance[8]. Not to mention the millions of patients that don't have the financial means or discipline for 6-8 months of trial and error. All of these factors lead to 50% control rates for the leading preventable cause of death in the world, and I think most would argue that's not good enough. Given our approach has and will continue to demonstrate clinical and economic superiority, clinicians will eventually be putting patients in harm's way by not adopting. We recognize this will take time and capital, but we will get there with our great partners like Mayo Clinic, Omron, and Medtronic. Payers stand to save billions (as we are 47% less expensive than standard of care, demonstrated by peer-reviewed evidence). Patients and employers who are increasingly on the hook for healthcare spending will benefit from the same cost reductions. Additional benefits include less missed work for trial and error and less "pill fatigue." Therapy non-adherence will diminish by eliminating the stacking of medications, which also impacts other diseases. None of these factors are included in our 47% cost savings evidence and will be accretive to the value. Providers will benefit from millions of open office visits, freeing time for higher quality (and more profitable) visits. There will be a meaningful contribution to alleviating physician burnout as we continue to apply the same approach to additional titration/switching visits across other similar chronic diseases. For this reason, we anticipate a future where our diagnostic is required before prescribing medications. Summarizing key points: • Each conventional BP medication has a bell-curve response with some patients showing a drop, some demonstrating no change, and approximately 20% showing an increase in BP. This variability is well-studied and true of each of the standard BP medication classes. • Each BP medication has an average response rate of 50% in the population. • Even when patients are adherent and taking their medications, as prescribed, 40% of these individuals still do not have BP under control. • There is a problem with layering medications • Each medication has a pronounced side-effect profile. These are not harmless treatments. • For each pill that we add to a patient's regimen, medication non-adherence increases by 70%. Non-adherence is a big problem in hypertension. • We have the only PGen HTN panel that has actual data behind it (in peer-reviewed publications). • We have demonstrated that patients who match our drug recommendation #1 show 36% lower BP from diagnosis to controlling BP. • Even with patients on monotherapy: if they match our recommendation, they are 50% more likely to meet the new more stringent blood pressure guidelines. • In a small pilot RCT against the standard of care (JNC-8, AHA, ACC guidelines), we demonstrated half of the serious adverse events, when compared to the standard of care. 1. Egan, B.M., Y. Zhao, and R.N. Axon, US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA, 2010.303(20): p. 2043-50. 2. Carey, R.M. and P.K. Whelton, The 2017 american college of cardiology/american heart associaBon hypertension guidelines: A resource for pracBcing clinicians. Annals of Internal Medicine, 2018.168(5): p. 359- 360. 3. Gu, Q., et al., Trends in anBhypertensive medicaBon use and blood pressure control among United States adults with hypertension: the NaBonal Health And NutriBon ExaminaBon Survey, 2001 to 2010. Circula+on, 2012.126(17): p. 2105-14. 4. Turnbull, F., et al., Effects of different blood pressure-lowering regimens on major cardiovascular events in individuals with and without diabetes mellitus: results of prospecBvely designed overviews of randomized trials. Arch Intern Med, 2005. 165(12): p. 1410-9. 5. Materson, B.J., et al., Single-drug therapy for hypertension in men. A comparison of six anBhypertensive agents with placebo. The Department of Veterans Affairs CooperaBve Study Group on AnBhypertensive Agents. N Engl J Med, 1993. 328(13): p. 914-21. 6. Gong, Y., et al., Pharmacogenomic Genome-Wide Meta-Analysis of Blood Pressure Response to beta- Blockers in Hypertensive African Americans. Hypertension, 2016.67(3): p. 556-63. 7. Chapman, A.B., et al., Predictors of anBhypertensive response to a standard dose of hydrochlorothiazide for essenBal hypertension. Kidney Int, 2002.61(3): p. 1047-55. 8. Gupta, P., et al., Risk Factors for Nonadherence to AnBhypertensive Treatment. Hypertension, 2017.69(6): p. 1113-1120.