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At the Molecular Marketplace, Diagnostics Strive for Center Stage

SAN FRANCISCO, March 24 (GenomeWeb News) - On the road to personalized medicine, this week's Molecular Medicine Tri-Conference in San Franciscomight just be a way station.

The meeting, which has gone through a series of name changes since Cambridge Healthtech Institute first organized it in 1993 as the Tri-Genome Conference, offers a glance at the shifting sands of genomics-cum-drug discovery--and this year is no exception.


Gone are the talks describing how genomic databases will change the face of drug discovery. This year, the two most popular tracks focused on medicinal chemistry and molecular diagnostics, according to Phillips Kuhl, president of CHI.


On the first day of the conference, representatives from Roche and Johnson & Johnson subsidiary Veridex recounted their companies' attempts to build businesses around the use of biomarkers as tools for classifying patients' ability to respond to specific drugs. Meanwhile, scientists at other big pharmas described their attempts to synthesize compounds capable of inhibiting the many targets discovered over the last few years with the help of genomics.


The attention paid to molecular diagnostics was made timely by the US Food and Drug Administration's attempts in recent months to remind creators of new diagnostic tests that their products might fall under FDA scrutiny. Thomas Metcalfe, head of Roche's biomarker program, described his company's efforts to produce a DNA microarray - with the help of Affymetrix - to determine whether patients' DNA contains certain SNPs in two cytochrome p450 genes that correlate with their ability to metabolize many psychiatric drugs. In response to an FDA ruling late last year saying Roche's AmpliChip might fall under its jurisdiction, Metcalfe reiterated Roche's desire to work in partnership with the government agency to bring the chip to market.


But compared to the challenges associated with receiving FDA approval for a diagnostic test, both Metcalfe and David Atkins, the general manager of Veridex, stressed that a bigger obstacle to commercializing new biomarker-based diagnostic tests lies in convincing reference labs and health care-reimbursement agencies of the inherent value the new tests can pass on to patients.


FDA approval aside, Metcalfe said, the bigger obstacle is overcoming the second-class status afforded to diagnostics compared to therapeutics, and convincing the powers-that-be that a "reasonable share goes to people who innovate and practice these tests."


Atkins put the problem in broader terms. Looking at the diagnostics industry as a whole, he said its advocates lack a convincing message that would "communicate the value of these tests." The result, he added, is a vicious cycle linking limited clinical validation with low reimbursement rates, depressed pricing, and unsustained investment in new tests. Studies showing the economic and quality of life benefits of new tests - as well as their safety - are the essential ingredients to reversing that cycle, he said.

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