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SkylineDx Follows Multiple Myeloma MDx With Collaborative Effort to Develop Therapy Selection Assay

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NEW YORK (GenomeWeb) – Building on an earlier test it developed for diagnosing multiple myeloma, Rotterdam, the Netherlands-based SkylineDx has now partnered with a couple of European institutes and a patient advocacy organization to pursue development of a tool that may be able to guide therapy selection for these cancer patients.

The partners recently received a €2.9 million ($3.2 million) grant from the European Commission under its Horizon 2020 Fast Track to Innovation program to develop the new microarray-based test, called MMpredict. SkylineDx will lead the consortium, which consists of partners at Erasmus University Medical Center and the Institute for Medical Technology Assessment in Rotterdam, as well the University of Torino in Italy, and Myeloma Patients Europe, a Brussels-based patient advocacy group.

Jeff Jones, executive vice president of commercial operations at SkylineDx, told GenomeWeb that the consortium aims to profile up to 800 multiple myeloma patient samples using the Affymetrix platform with the aim of developing a list of biomarkers that can be used to select the optimal therapies for cancer patients.

"The grant is based on the microarray technology we are using now," Jones said. "That is our expertise, our partners have it, so that's what makes most sense."

Backed by investment firm the Van Herk Group, SkylineDx was established in 2013, at which time it acquired the IP and assets of Skyline Diagnostics, a defunct molecular diagnostics company that had developed a microarray test for acute myeloid leukemia, called AMLprofiler. The same year, SkylineDx launched MMprofiler, a gene expression test for diagnosing multiple myeloma patients into high and standard risk groups based on a 92-gene signature called SKY92.

Last November, SkylineDx secured CE-IVD marking for the test, enabling it to offer MMprofiler as a clinical diagnostic in Europe, positioning it as an alternative to fluorescence in situ hybridization and other conventional tests.

All of SkylineDx's tests have been based on the Affymetrix platform, and Jones said that the SKY92 signature will form the foundation for the company's discovery work during the MMpredict project, though it intends to use a whole-genome gene expression array to discover new markers.

"This grant will look further into our gene set," said Jones. "It may turn out that the probe sets we have on there are predictive, but we are looking at other sets that could be added to ours, or some combination thereof," he said. "The research will make that clear to us."

According to Jones, most of the R&D for the MMpredict project will be carried out at SkylineDx's laboratory in Rotterdam. Jones is based at SkylineDx's US office in Laguna Hills, California. He joined SkylineDx last year after serving as executive vice president of global marketing for Agendia, another Dutch molecular diagnostics company with a microarray test menu, for two years. At SkylineDx, he has been charged with overseeing the development of worldwide sales networks.

Jones said that at present SkylineDx continues to build its commercial team in Europe, looking to make its CE-IVD-marked MMprofiler test available to more clinical labs as a centralized test offered out of its Rotterdam lab as well as in a kitted format.

The company's US operation is similarly adding staff and the company continues to court biopharmaceutical companies with its offerings. Last month, SkylineDx registered a prospective multiple myeloma impact study with clinicaltrials.gov. The study, which has not yet begun recruitment, aims to measure the impact of MMprofiler on treatment intention decisions in active multiple myeloma patients.

According to the study description, SkylineDx and partners will enroll up to 250 patients at up to seven US centers and follow them for five years after diagnosis, analyzing their tumor samples using MMprofiler as well as other cytogenetic and gene expression markers. The study is expected to commence in December and run through the end of 2022.

As part of the study, SkylineDx is collaborating with Medex15, a clinical trials services company. Saad Usmani, director of clinical research for hematalogic malignancies at Carolinas Healthcare System is named as the principal investigator on the study.

SkylineDx is also eyeing the Japanese market. The company recently announced that it had received a patent allowance for the SKY92 signature from the Japan Patent Office. SkylineDx CEO Dharminder Chahal told GenomeWeb last week that the allowance removes any uncertainty over whether or not SkylineDx's IP will be protected in Japan, enabling the company to attract more potential clients there.