By: Maureen Kingsley

Already attracting such high-profile members as Gen-Probe and bioMerieux, AdvaMed Dx is governed by an 18-member Board of Directors and an eight-member Executive Committee, both of which comprise IVD-company CEOs. The Board of Directors is led by Scott Garrett, chair of Beckman Coulter.

 

The new group’s primary goal is to “advance and promote the value of diagnostics within the whole realm of healthcare,” says Garrett. “I think more and more today there are different priorities in the IVD sector than in the broader-based medical device industry. And while I never expect us to be in conflict with the AdvaMed agenda, I think there will always be differences in our priorities. We need a unique and dedicated voice and direction for IVDs because there are so many differences that make IVDs a unique sector within medical devices.”

 

Garrett adds that AdvaMed was a very effective way for IVD companies to interface with FDA. But the current healthcare reform debate brought to light the need for IVD companies to be “more clear about what IVDs represent in terms of value proposition for patients, hospitals, physicians, and healthcare in general,” he says.

 

The group, whose first meeting was scheduled for February 26, expects to tackle issues within the areas of regulation, reimbursement, international concerns, and legal matters. Garret offers the example of reimbursement for new molecular tests, pointing out that this area is not well defined. “We really need to get CMS—either through legislation or by coming up with better rules and methods—to give us a better idea of the value that’s available to companies that are doing R&D on new molecular markers that will be quite valuable to doctors as they diagnose many significant illnesses,” he says. “The whole approach to reimbursement for our customers, for clinical testing, leaves a lot to be desired.”

 

AdvaMed Dx plans to establish a basis for dialog, understanding, and collaboration within international markets, especially China, India, and Japan. “Clinical diagnostics is clearly a global industry with global competitors,” Garrett says. He points out that nearly all of the major American diagnostics manufacturers compete to a significant degree in all of the developed countries of the world—and in many of the emerging markets. “So it’s important for our new diagnostics association to be capable of representing the industry in China, throughout Europe,” he says. “That’s going to require excellent relationships with local associations and a willingness to cooperate, coordinate, and collaborate with them to advance the value proposition associated with diagnostics and make sure that regulators, legislators, and payers in any of those countries or markets are well aware of the value that diagnostics can bring.”

 

The new division’s members are very interested in getting their message across to Congress and state legislators, so that as these lawmakers consider ways to improve healthcare for their constituents, they are “aware of the role we play and don’t look at us as just another medical device sector that’s somehow driving up the cost of care,” Garret says.

 

At the time of this interview, Garret said the group’s priorities were to hire an executive director and to have a first meeting of the board of directors. “It’s especially important to me that we get off to a fast start,” he says.

 

Teresa Lee, vice president, payment and healthcare delivery policy at AdvaMed, adds that as the organization goes forward with its new division, it will “employ all of the methods we’ve used in the past. But we want to be working hand in hand with the other stakeholders and players in the space and have a collaborative working style.”

 

Garrett calls the association-within-an-association strategy “elegant” in that it serves to ease any tension that may exist between IVD companies and the larger medical-device conglomerates of which they are a part. “Most of the biggest IVD companies are subsidiaries of bigger companies,” he says. “Those big diagnostics companies that are part of conglomerates aren’t interested in having multiple associations representing their interests. We need to find a way to advance the value proposition for diagnostics and advance the agenda of diagnostics without waiting in line as part of AdvaMed, which was becoming somewhat frustrating for many of the companies. I think this is a great way to do it,” he says.