This story has been updated to include comments from a company official.
NeoGenomics Laboratories will market Signal Genetics' Myeloma Prognostic Risk Signature test to hospital-based hematologists and oncologists in the US, Signal Genetics said this week.
New York-based Signal Genetics launched the MyPRS Test in December and offers the assay through its Clinical Laboratory Improvement Amendments-compliant lab in Little Rock, Ark. (BAN 12/14/2010).
Headquartered in Fort Myers, Fla., NeoGenomics has labs in Nashville, Tenn., and, Irvine, Calif., and specializes in cancer genetics diagnostic testing. Results of the MyPRS test, which will still be performed by Signal, will be now be incorporated into NeoGenomics' test reports to be provided to its customers along with other ancillary diagnostic tests, Signal Genetics said.
The test is based on the Affymetrix GeneChip microarray platform and uses a gene-expression signature to predict a patient's progress and enable personalized treatment decisions, according to the firm.
Signal Genetics CEO Joe Hernandez used to manage Affy's gene expression product line.
Signal Genetics in March inked a similar marketing deal with Pronto Diagnostics to distribute MyPRS in Israel. It signed another deal with Caris Life Sciences earlier this year, enabling Caris to market the MyPRS test to community-based hematologists and medical oncologists in the US.
"As a start-up company, we made a strategic decision to partner with specialty labs that have existing relationships with our target market instead of creating our own sales organization," Greg Richard, Signal Genetics' vice president of commercial operations, told BioArray News this week. "This relationship enabled us to launch our new test more quickly."
Richard said that the deals with NeoGenomics and Caris are exclusive for each company's respective market segment. "Caris is our partner for community-based hematologists [and] oncologists and now NeoGenomics is our partner for the hospital-based [hematologists and oncologists]," he said. "Now that we have the entire … market covered through these two relationships, we are not seeking another commercial partner at this time," he added.
MyPRS is the first of a number of tests in Signal Genetics' pipeline. The year-old firm maintains two subsidiaries to offer its tests: Myeloma Health offers its myeloma-related diagnostics, while Respira Health focuses on the market for lung cancer tests.
According to its website, Signal Genetics plans to introduce two more myeloma-related tests over the next year, while a lung cancer test is scheduled to become available later this year. The firm also has a prostate cancer test development program.
Richard said that, going forward, Caris and NeoGenomics have the "first right of negotiation for any new tests we develop or license."
Hernandez claimed at the time MyPRS was launched that the firm's array-based gene expression test offers more detailed profiling information than the fluorescence in situ hybridization and cytogenetic-based assays that are currently on the market.
Signal acquired an exclusive license to the technology behind the new test from the University of Arkansas Medical Sciences last year. In September 2010, Signal said it would use the MyPRS testing platform in a multiple myeloma research program being conducted by Array BioPharma (BAN 12/14/2010).
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Signal Genetics offers its tests on a standard Affy expression array, Richard said. "The primary reason is that it is the technology that was used to conduct the research over the past 10 years that created our outcomes database, which is the basis of the MyPRS test," he said. "That does not mean, however, we wouldn't consider other platforms," he added.
According to Richard, Signal Genetics plans to introduce two more myeloma-related tests over the next year.
"We have two enhancements to the MyPRS test coming in the next few quarters, specifically MyPRS Plus and MyPRS RX," he said. The Plus product will incorporate additional data, such as the molecular subtype and virtual karyotype of the patient, while the RX test will provide pharmacogenomics information to "assist with the identification of the most appropriate therapy based on an individual patients' signature," he said. "These both have to be validated before they can be added to the base product offering."
According to its website, a lung cancer test is scheduled to become available later this year. The firm also has a prostate cancer test development program.
"We have other signatures coming to market in solid tumors as well, both via our own development efforts as well as licensing arrangements," said Richard. "The two areas we are currently pursuing most aggressively are colon cancer and lung cancer."
He noted that the firm's MyPRS test is a laboratory-developed test that is being performed in a CLIA-certified lab. "At this point the [US Food and Drug Administration] is not regulating LDTs," he said of the status of the firm's test. However, he acknowledged that "there is a lot of discussion about this in the industry."
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