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Decentralized MDx Testing Gaining Steam but Obstacles Remain, Industry Execs Say

NEW YORK (GenomeWeb News) – Molecular diagnostic testing is making headway into decentralized settings, such as hospitals and smaller labs, despite continuing obstacles to their widespread adoption, industry executives said yesterday at the Piper Jaffray Conference held here.
Executives from four molecular diagnostic firms – including Gen-Probe, Nanosphere, Cepheid, and Qiagen – participated in a panel discussion on the trend of decentralization moderated by Piper Jaffray analyst Bill Quirk. All of these firms have a stake in pushing their technologies into this largely untapped market for MDx tests.
Currently, most molecular diagnostic tests are run in either large centralized labs, such as those operated by Laboratory Corporation of America and Quest Diagnostics, or in CLIA labs. But as more molecular diagnostic tests are developed, particularly for conditions for which physicians would like to have a rapid answer, decentralized labs and near-patient settings are viewed as a viable and growing market.
Cepheid CEO John Bishop pointed to three key drivers of decentralization. First, he said, is the increasing virulence of infectious diseases. Bishop’s firm has grown its revenues over the past couple of years through the sale of molecular tests for hospital-acquired infections, and it has targeted hospital labs as the primary market for those tests.
Bishop also said that as the next generation of therapeutics hit the market, many will require a companion diagnostic. He pointed to antibiotics as a primary example of this prediction.
He also said that poor patient adherence to drug regimens and a need for better drug monitoring for diseases such as cancer would be a driver of decentralization going forward.
Gen-Probe Chairman Henry Nordhoff noted that as personalized medicine advances, that will necessarily demand that some molecular diagnostics be brought into the physician’s office as well.
William Moffitt, president and CEO of Nanosphere, added one other factor feeding the trend: “the desire for medicine to be local.” He said that part of that desire was a need for faster turnaround time on diagnostic tests.
However, he noted that this need was running head on into the healthcare system’s focus on keeping costs down, which pushes diagnostic testing into centralized settings. As a result, Moffitt said it is likely that some molecular diagnostic tests will end up running in both centralized and decentralized labs.
But one issue that may prove to be an obstacle for running molecular diagnostics in hospital labs is their relative complexity, noted Jim Godsey, senior VP of R&D in North America for Qiagen. He said that new automated systems that are easier to use are needed for the hospital lab setting – a suggestion supported by a number of firms working on such advanced automated systems.
All of the panelists agreed that while the US Food and Drug Administration wants to see more companion diagnostics, the agency is likely to tighten regulations. New regulations, such as those governing multivariate assays, will likely make FDA clearance more difficult and more onerous for test developers, said Bishop.
As a result, Godsey said, manufacturers are going to have to be more diligent in doing their R&D on potential molecular diagnostic tests.
The panelists also noted that healthcare reform is likely to be a key factor in how quickly MDx tests are adopted in decentralized labs.
Bishop said that molecular diagnostics bring a “value add” to the healthcare system, but the current thinking on the cost of care needs to be addressed. Currently, Bishop noted, policymakers view the cost base “in a silo,” without considering the money that would be saved overall by using the more sophisticated, though more expensive, molecular technologies.
Moffitt agreed, saying that the tools already exist to take cost and waste out of the healthcare system, but the question remains how to get the system, which is slow to change, to adopt these tools more rapidly.

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