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Mount Sinai Lab Joins Roche Molecular s Program to Validate, Use Early PGx Assays

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Roche Molecular Diagnostics and Mount Sinai Hospital in New York have signed a three-year collaboration that will designate the hospital's Molecular Pathology Laboratory as a Molecular Center of Excellence and give the lab early access to assays under development by the diagnostics giant.

In return, the pathology lab will help Roche develop new products and field-testing products before they hit the market. "If anything comes out [in early development] that we need for clinical use, and they have something in early-stage [development], we will get it first in our hands, and we'll try and validate it," eventually putting the diagnostic in clinical practice, David Zhang, director of the laboratory, told Pharmacogenomics Reporter this week.

The company's center-of-excellence program includes several clinical laboratories in the United States. St. Luke's Hospital in Kansas City, Mo., signed a five-year deal in December 2003 to become a center of excellence that field-tested Roche PCR diagnostics, as well as "other advanced genomic technologies," the companies said in a statement. Oregon Medical Laboratories, based in Eugene, Ore., joined the program in February last year to test similar products, with an emphasis on PCR-based pathogen-detection assays.

"The reason we think this will benefit [Mount Sinai] is that we're a tertiary care center — we have a lot of programs that request very specialized tests [that] no commercial labs offer at this time," Zhang said. The pathology laboratory will receive a discount on Roche diagnostic products through the center of excellence program, as well, said Zhang.

Zhang mentioned a Bcr/Abl gene-expression test for monitoring treatment with Novartis' Gleevec, along with EGFR tests for guiding treatment with AstraZeneca's Iressa, as examples of rare tests for which the Mount Sinai pathology lab has a need. "Not many labs offer that [Bcr/Abl] test, so we want to develop this assay — meanwhile Roche has a kit, although this kit is not designed to detect this RNA," he said. "Rather, it's a generic kit, and we can take [it] and modify it to fit our uses — that's the whole concept."

The pathology lab will also be involved in other areas of pharmacogenomics, including testing with Roche's CYP450 AmpliChip, which the lab will use to recommend dosages for certain drugs to Mount Sinai's clinicians, said Zhang. Most of these will likely be psychiatric drugs and anesthetics, he added. The laboratory has not yet decided which area it will concentrate on first, although its choices might follow the facility's specialties. "Oncology's one of the big areas we're going to target — probably we'll study EGFR [or Bcr/Abl] before we study P450," said Zhang.

Roche would probably jointly develop an assay with the Mount Sinai lab for applications for which it does not yet have a test, such as EGFR, said Zhang. "MCOE set up the ground for us to collaborate on … we will support [Roche] from the clinical side — to validate — and they will use this information to help them to decide in the future how to produce a kit," Zhang said.

The MCOE signed its contract with Roche earlier this month, and it held its first meetings last week, Zhang said. Zhang did not know how many patient samples might be tested annually through the program. The Mount Sinai pathology lab performs more than 6,000 medical laboratory tests of various kinds each year, according to a hospital statement.

— Chris Womack ([email protected])

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