Personalised Genetic Diagnostics

I  was at the ‘Burrill Personalised Medicine in the Clinic: Beyond Canceræ’ panel, where G Steven Burrill invited me to explain for the audience, ‘Why don’t you take your company and products to China?’ My response at the moment was fairly succinct and addressed our need to focus on domestic (United States) production and follow with a launch of our products during the last half of 2009 throughout the entire Asian Pacific Rim. Our goal is to translate the operational model to Asia and determine which nation would provide a most functional international headquarters. Corporate distribution channels and ‘trusted relationships’ are essential in the effective development of an ‘International Brand.’

Physician interaction and feedback on clinical relevance has been integral in advancing the utilisation and acceptance of our products. Over the past year, our corporate resources have been committed to building a substantial sales team (we expect >200 trained sales representatives by May) and refining the operational requirements (expansion to 19 regional facilities to optimise turnaround time) for providing personalised medical genetic diagnostics that impact clinical ‘decision making.’ Gaining the physician’s acceptance of our products and optimising the clinical utility is our primary focus.

Our initial product launch has been the Warfarin (brand name, Coumadin) sensitivity panel (FDA approved our panel in January 2008), where our primary market consists of mainstream clinicians. I feel, our acceptance among cardiologists, hematologists, and all other mainstream specialists, is a crucial element to our international launch. With our Warfarin sensitivity panel, we are able to provide a viable product that addresses a real problem in standardising the dosing based on an individual’s genes. Penetrating this market and establishing an optimal service component will enable a commercialisation pathway for future and more progressive DNA / RNA-based healthcare products.

Managing risk through gene testing
In August, 2007, the FDA updated labelling on warfarin. This oral anticoagulant is most frequently used to control and prevent thromboembolic disorders, indicating that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug. FDA black box warnings notify physicians that patients over 65 years of age using this drug carry a higher risk for bleeding and require special vigilance. This information, combined with numerous clinical studies, has encouraged physicians to recommend genetic testing to better support determining a patient’s optimal dose, since too high of a dose contributes to life-threatening bleeding, and too low places the patient at risk for life-threatening blood clots. Studies have indicated that 89 per cent of Asians carry at least one sensitive version of the VKORC1 gene, placing this population at an increased risk for ‘bleeding out’, when consuming higher concentrations of the drug. We utilise software that incorporates the growing number of variations into a dosing algorithm that automates the reporting process and more effectively supports the dosing evaluation and continued maintenance of the patient.

Gene testing and close monitoring is critical to millions of patients who are prescribed Warfarin (Coumadin) due to the high incidence of side-effects, many that are life-threatening. Warfarin is the second most common drug, after insulin, implicated in emergency room visits for adverse drug reactions. The Wall Street Journal reports that 85,000 serious bleeding events and 17,000 strokes a year could be prevented using genetic testing, saving US$ 1.1 billion a year in the US alone. However, the complexity of the US multi-payer system and the perceived lack of coordination between the regulatory agencies has yielded a slower than anticipated rate of acceptance in the US market. The process of implementing Warfarin sensitivity DNA testing as a standard of care has been extremely slow.

Today, there are four FDA-approved platforms for Warfarin sensitivity genotyping, with each receiving approval over the course of this past year (2008). CMS (Centers for Medicare and Medicaid Services), however, has postponed making a decision on payment for the FDA-approved tests until later this year. Progressive hospital networks have adopted our ‘pilot testing’ programme, while many other networks await JCAHO’s (The Joint Commission on the Accreditation of Healthcare Organizations) decision to mandate the testing as a requirement for retaining hospital credentialing. Many retired physicians (who have prescribed Warfarin and understand the issues with dosing) are approaching Iverson and volunteering to assist in our efforts; while most practicing medical professionals are cautious about affiliating with the company due to strict and highly regulated US Stark Laws. As we burgeon through the obstacles in the US healthcare reimbursement system, we continue to provide the test as a service for physicians initiating Warfarin. In the interim, we are actively seeking corporate partners in the Asian market to affect a transfer of technology that will be prepared to address the need of millions of the Asian population on Warfarin that will benefit from receiving a personalised dose.

Gaining clinical acceptance
Our company’s strategy has been to follow the FDA guidance in gaining subtle acceptance and implementation through the re-labeling of several widely prescribed medications to gain clinical acceptance. We have focussed our entire effort on complying with the recommendations of the regulatory agencies. Iverson has also expressed an extreme concern over the direct-to-consumer approach taken by several whole genome DNA testing companies. Our position is that direct-to-consumer genetic tests should be advertised as ‘genomic art’ to avoid the increase in general anxiety that they will introduce without including a properly informed healthcare provider. This approach will allow our organisation to establish a sound reputation and a corporate brand that can readily translate into the global marketplace. Like other leading researchers and scientists, Iverson is committed to its goal of expanding the use of genetic diagnostics by moving the healthcare model towards a more informational model based on preventative, personalised and predictive medicine. Iverson tests will provide a ‘genetic roadmap’ for both patients and physicians allowing them to better understand healthcare options and shape healthcare decisions within targeted populations.

In the interim, as I’m physically writing this and listening on a conference call to a coalition of companies discussing the pending ‘battles’ with legislation to receive payment for more advanced personalised medicine applications, I find myself placing a considerable amount of thought into Mr Burrill’s question, “Why don’t you take your company and products to China?” Given time to reflect over this and considering the tremendous need in the region, I am enthusiastic about moving forward with the right political or corporate partner that will work with us in a technology transfer to make personalised medicine a present-day application in Asia.