Leaders in the personalized medicine field have launched a non-profit organization, called DxInsights, focused on educating policymakers, the healthcare industry, insurers, and patient groups about diagnostics and their importance to medical care.
Last week at the Biotechnology Industry Organization's international convention in Boston, DxInsights founders hosted an event to broadly raise awareness of the organization, which officially launched in January. Founders include Mara Aspinall, CEO of Roche subsidiary Ventana Medical Systems; and Kristin Ciriello Pothier, a partner at the healthcare consultancy Health Advances.
Aspinall, formerly president of Genzyme Genetics, told PGx Reporter this week that there is a need for an independent, educational entity solely focused on the diagnostics industry due to the explosion of technologies in this space and the increased utilization of such tests to personalize treatments.
On the DxInsights' newly launched website, the organization states that its mission "is to educate healthcare stakeholders on the power and value of diagnostics and their impact on improving patient outcomes and reducing costs." DxInsights will focus on fulfilling its educational mission by providing information on its website on all things related to the diagnostics industry; by hosting forums through which stakeholders can discuss critical issues impacting the industry; and by sponsoring and presenting research that is useful industry-wide.
Visitors to the DxInsights website can get scientific research, industry reports, legal decisions, M&A news, as well regulatory and reimbursement information all focused on the diagnostics arena. "We want to be the resource that has the core information in one place," Aspinall said.
DxInsights currently has plans to host two educational forums each year — a Spring/Summer meeting in Boston and a Fall/Winter meeting in Tucson, Ariz. — as a way to facilitate dialogue and educate stakeholders who lack knowledge of the field. The organization has garnered initial interest from a wide range of parties, including drug developers keen on learning more about how to advance personalized drug/test combination products and medical schools seeking to add diagnostic courses to their curricula.
Additionally, DxInsights has plans to hold a private company analyst day in early 2013, focused exclusively on diagnostics. During this analyst day, diagnostics will be "front and center," Aspinall said, and "it will give analysts an opportunity to understand what's happening in the industry."
As an independent, non-profit entity, DxInsights will also fund studies and collect research data about the industry. However, none of the research sponsored by DxInsights will focus on any one company or academic center. "In that way, we will move industry forward by putting something together that is useful across many different companies, labs and centers, but doing it under the independence of DxInsights," Aspinall said.
In January, DxInsights released its first white paper, titled the Essentials of Diagnostics, which lays out a critical problem hindering the industry: Diagnostics influence greater than 60 percent of healthcare decisions, but comprise less than 2 percent of spending worldwide. Among stakeholders in the US, there is certainly a recognition of this problem, but due to the fragmented nature of the industry – with laboratory test developers, in vitro diagnostics firms, and in vivo test makers all operating under different business models and regulatory structures – solutions have often been elusive.
For example, the US Food and Drug Administration has for many years tried different strategies through which to increase its oversight of laboratory-developed tests. However, none of the proposed solutions – from focusing regulation specifically on multi-gene, algorithm-based lab tests to proposing a risk-based, staged approach to bringing all LDTs under FDA oversight – appear to have met the needs of laboratory test makers, which as a group comprise hospital-based, reference, academic, and physician labs all performing tests for myriad conditions, both chronic and rare (PGx Reporter 7/28/2010).
Similarly, in the reimbursement arena, although there is agreement that most payment schemes don't capture the value that diagnostics bring to patient care, the medical testing industry can hardly agree on the nuts and bolts of a system by which tests should be coded and billed so that insurers have better knowledge of what specific interventions are being performed (PGx Reporter 12/21/2011).
It won't necessarily be DxInsights that aligns disparate interests in the diagnostics industry around these contentious issues. However, the organization will try to foster better knowledge and communication among industry players about such topics. "There are a number of very important organizations in the diagnostics field, including the American Clinical Laboratory Association, AdvaMed, the Personalized Medicine Coalition, and the Coalition for 21st Century Medicine. But what there is not currently is a non-profit, independent, non-partisan organization focused on educating the healthcare community about the importance of diagnostics," Aspinall reflected.
"There are many people who would like to change many aspects of the diagnostics industry. That's not what DxInsights is for," she continued. "We want to make sure that the foundation [of knowledge about the industry] is strong so, when you're on Capitol Hill or when you're talking to a payor about changing things, everyone has a common base of understanding about how the system works today."
In her time working within industry, Aspinall has found that although the life sciences community is well versed in the key issues around the development, marketing, regulation, and reimbursement of therapeutics, it doesn't have the same comfort level when it comes to diagnostics. The need for healthcare stakeholders to improve their understanding is become more critical as diagnostics begin to play a more integral role in the delivery of individualized treatments. However, due to the fragmented nature of the diagnostics industry, there are information gaps when it comes to even some basic facts and figures.
"Nobody had put together, for example, [the diagnostics industry-wide] employment numbers for the US," Aspinall pointed out. In its white paper, DxInsights reported that there are more than 300,000 employees working in laboratory services and more than 250,000 employees in test development and innovation. These employees advance the research and develop tests that bring in revenues of more than $100 billion, according to the paper.
Moreover, DxInsights believes that as more personalized medicine products are launched, it will be important to spread the knowledge that as much as 50 percent of marketed drugs lack efficacy, and companion diagnostics can help doctors match patients to drugs they are most likely to respond to, thereby saving as much as $15 billion.
"That kind of information didn't exist in the industry and is defined in very different ways," Aspinall said. "We wanted to bring together the existing research so we could get a clear picture of [the industry]."
In addition to Aspinall and Pothier, DxInsights was co-founded by Hathaway Pease Russell, a partner at the law firm Foley Hoag; and Terri Clevenger, president of Continuum Health Communications. Ray Woosley, who recently retired as president of the non-profit Critical Path Institute, will head up DxInsights' scientific advisory board and steering committee. Mickey Urdea, chief scientific officer of the diagnostics firm Tethys, will lead the research studies committee; and Kieran English of the executive search and assessment company Russell Reynolds will be in charge of the educational committee.
Continuum Health Communications, Foley Hoag, Health Advances, PriceWaterhouse, and Ventana Medical Systems are providing an undisclosed amount of initial funding for DxInsights' operations. In the future, "we will look for funding from foundations, companies, [and] institutions that will help fund specific events, like open forums? on a particular issue, as well as contributing to an independent research study," Aspinall said. "What is critical and will remain is the independence of the organization."
There is no membership fee for diagnostics industry professionals joining DxInsights.