Signal Genetics is moving forward with two new iterations of its multiple myeloma progression test, including a pharmacogenomics assay called MyPRS RX to help inform drug therapy decisions.
The company recently announced a partnership with NeoGenomics Laboratories to market its Myeloma Prognostic Risk Signature test, MyPRS, to hospitals. MyPRS RX, which the company expects to release by the end of the year, will be a pharmacogenomic enhancement of the existing test, adding drug recommendations to the initial test's gene-expression signatures, Greg Richard, Signal Genetics' vice president of commercial operations, told PGx Reporter this week. The company is planning another enhancement of the test, called MyPRS Plus, which will add myeloma subgroup analysis.
"MyPRS RX is going to be the third iteration of the basic 70-gene expression profile [MyPRS] test," said Richard, who explained that Signal Genetics is analyzing patient outcomes data from its dataset of 6,000 samples from 1,000 patients, which he said is the largest available resource for multiple myeloma. The company's researchers are using the data to link information on treatment outcomes with patients' genomic profiles.
He said the company hopes to be able to launch the PGx test by year end.
"Certainly it is something we want to have out in the marketplace and in the hands of our commercial partners as soon as possible, no later than the first of next year," he said.
In addition to its agreement with NeoGenomics, Signal Genetics also has a partnership with Caris Life Sciences to market MyPRS to community-based hematologists and medical oncologists. It has been the company's general strategy, Richard said, "to use partners to … seed the marketplace, because they have existing relationships and can penetrate the market more quickly than we could have had we developed and built out own sales organization."
When MyPRS RX is completed, Caris and NeoGenomics would share the first rights to market the new test. "It's certainly our expectation that [NeoGenomics and Caris] are going to adopt any new versions, because they're improvements to the existing test," Richard said.
The basic MyPRS test is performed in Signal Genetics' CLIA-certified lab and is based on intellectual property acquired from the University of Arkansas. The test gives a score from 0 to 100, with a cutoff point of 45.2, below which multiple myeloma patients are considered at low risk for recurrence with a 73 percent probability of being recurrence free at five years. Patients who receive a score above the cutoff point are at high risk or recurrence, with a 26 percent probably of being free of relapse at five years.
The test is run on an Affymetrix's GeneChip Human Genome U133 Plus 2.0 array and measures the expression of 70 genes. Both the gene set and the platform will carry over to MyPRS RX, Richard said, as well as to MyPRS Plus, which the company also plans to release this year.
"We're going to be consistently interrogating, if you will, those same 70 genes for the other two versions," Richard said.
MyPRS Plus will add subgroup analysis to the current high-risk/low-risk scores provided by MyPRS, so physicians will be able to divide patients into as many as eight known myeloma subtypes, which carry their own risk associations.
MyPRS RX, Richard said, will then add another layer of information on the efficacy of treatments on long-term progression and outcome, focusing on three main "therapeutic decisions" comprising the standard of care for multiple myeloma: bone marrow stem cell transplants and the drugs Velcade and Revlimid.
Richard stressed that MyPRS RX and MyPRS Plus have not yet been validated, but said that Signal Genetics feels "very confident" that the company will be able to commercially launch these tests within "reasonable timelines."
"The retrospective data to do it is available," he said. "So it's really a matter of whether we want to wait and have more prospective data, or do we go with retrospective data, which is obviously robust, since we've done this on 6,000 plus samples over 10 years."
Considering the US Food and Drug Administration's evolving plans for the possible regulation of laboratory-developed tests, Richard said Signal Genetics is "watching closely" what is decided.
"We're prepared [and] equipped to go down a different path if that's what is required" by the agency, he said.
Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at mashford [at] genomeweb [.] com.