Medical Device Daily

NEW YORK — Molecular testing, otherwise known as genetic testing, is the hot new thing in the diagnostics market. But don't expect it to elbow aside the broad array of standard tests already out there — or at least not very soon.

Besides the maze-like clinical, regulatory and reimburse- ment paths to be negotiated for this expanding sector, genetic testing is likely to complement rather than supplant other testing modalities, according to a panel of experts discussing the role of molecular testing at last week's Piper Jaffray Health Care Conference at the Pierre Hotel near Central Park in midtown Manhattan.

Douglas Harrington, MD, CEO of Specialty Laboratories (Santa Monica, California), noted that among the “evolutions and revolutions“ in diagnostics, new technologies “always appear to come slower than the hype would lead to believe. There's a lot of technology well proven that physicians are using on a daily basis, but the burden of proof [for their wide adoption] is to show clinical validity.“

As an example, he cited oncoming assays for autoimmune diseases. There is an “intense need to get more specific intensity“ for such tests and that they are “moving into the clinical lab,“ he said. But he noted the proof burden is on manufacturers to demonstrate that they actually bring additional value and expand on what is already available.

And he projected that the opportunities for such tests would develop “fairly rapidly over the next five years, though not to the degree that the manufacturers would hope.“

Ron McGlennen, MD, president of Access Genetics (Eden Prairie, Minnesota), said his company is focused on “helping hospitals to bring molecular diagnostic testing into their facilities“ and that a critical tipping point is “how to get [hospital laboratorians] to think differently to include DNA and RNA“ materials to test. He added that this has been “a challenge around for eight or 10 years.“

Still another gatekeeper in determining uptake is the physician, according to Gail Page, president of Ciphergen Diagnostics (Fremont, California), which focuses on proteomics, the study of the proteins produced by genetic variations.

“Physician education is a critical component [for adoption],“ she emphasized. “If they don't understand [a test] and don't order it, it won't become standard of care.“

As a corollary to this, she suggested that rather than starting with a test and then developing an application for it, a manufacturer would do better to focus on an unmet clinical need “and direct [its] research to produce assays“ meeting that need as a clearer pathway to adoption and reimbursement.

Thomas White, chief scientific officer for Celera Genomics (Alameda, California), also emphasized that new genetic tests must provide information that “goes beyond“ that provided by standard tests in order to “trigger“ their general acceptance.

White projected that one area of growth where this will happen is in assays for pharmaceutical firms that provide “expression profiles to predict the efficacy of their drugs. The pharma industry is becoming more proactive about getting that information to the FDA and looking for diagnostic partners in the service and manufacturing industry.“

Validation comes with “replication, replication, replication,“ he said, and with research done in more than “a single population.“

Population-based studies, White noted, “have the advantage of showing how genetic tests can be performed relative to standard tests or against standard methods of biochemical testing.“ Then must come “peer-reviewed articles and multiple peer-reviewed articles.“

McGlennen said that many funding agencies are looking for “pan-ethnic, transnational sorts of studies of thousands of patients to establish statistical strength.“

According to Harrington, validation studies also need to come in three flavors: “analytical, clinical and economic.“

Harrington said that Specialty Laboratories is in the business of helping new genetic tests move “closer to the patient“ via the hospital market. “We partner with hospitals to provide full services [for a test] until there is enough volume or expertise. We support that and then replace it with a new test.“

And he projected that over the next two years diagnostics will see “a rate of change equal to the last 100 years,“ thus creating “a huge opportunity“ for Specialty and other firms in the sector.

McGlennen described the pathway for molecular diagnostics acceptance as “no different than other areas of clinical lab tests in an earlier era — namely, that relatively new tests reside principally in specialized labs and then are evolving into the hospital and smaller laboratories, [then] to the private pathologist and point of care.“

Overall, Page also saw greater centralization of these procedures and that “not one will dominate the market.“ Rather, genetic tests, she predicted, will complement proteomics and current standard test methodologies. “There is room for all of these technologies. It just depends upon staging of the patient and characterization of each individual's test,“ she said.

As with most discussions of new technologies, the panel concluded by focusing on the importance of reimbursement.

Harrington called winning reimbursement “a challenging sport.“ McGlennen called it “absurd“ and a “combat.“ Ratcheting those descriptors up a bit, Page said of reimbursement: “It's a war.“

The reasons for delays in reimbursement, according to Harrington, are that “payers lag behind clinicians, who lag behind research scientists, who, in some cases, lag behind companies doing these things.“ The crux of achieving reimbursement coding, he said — and undoubtedly coming as no surprise to anyone in the industry — is “a lot of lobbying and effort.“

While noting the adversarial nature of the mechanics of reimbursement, Page conceded “a lot of progress“ in this area as compared to seven or eight years ago.

And she suggested that the lobbying effort should be broad-based.

“Advocacy groups and associations can be very helpful and can make a difference. They will be very willing to lobby with you and work side by side. There's a mechanistic way to go direct to consumer to influence the Hill and influence the payers.“

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