Dutch molecular diagnostics company SkylineDx recently established a presence in Boston to bolster its outreach to the North American market.
The Rotterdam-based firm, which has developed and launched microarray-based tests for acute myeloid leukemia and multiple myeloma in the EU, is now setting its sights on US clinicians and customers, according to Chris Williams, SkylineDx's vice president of business development.
"The US is certainly the biggest market, and we have two arms to our approach," said Williams. "We want to get a relationship with a CLIA-compliant lab provider so that they can run it as a laboratory-developed test," he said, "but we are also very interested in pharma companies."
Williams spoke with BioArray News during the American College of Medical Genetics and Genomics' annual meeting, held last week in Nashville, Tenn. He joined the firm in January from PerkinElmer and has been charged with pursuing the firm's business opportunities in the Americas, already with some success.
"We just signed up a lab for AMLprofiler," said Williams. "They installed an Affymetrix system and should begin running samples within the next month or so."
AMLprofiler relies on cytogenetics, mutation analysis, and expression analysis to subtype patients with acute myeloid leukemia. The company achieved a CE-IVD marking for AMLprofiler in 2011. SkylineDx offers another assay called MMprofiler that relies on a 92-gene expression signature to stratify and subtype multiple myeloma patients. Both assays are run on Affymetrix's GeneChip platform.
While the company has seen AMLprofiler adopted in Europe and the Africa, Williams said that American customers have actually shown more interest in MMprofiler, and that SkylineDx is "more opportunistic" when it comes to that assay, in part because of its appeal to pharma customers, "especially ones that have an MM drug pipeline that could use it to do patient stratification.
"That would help pharma companies early on to treat the right patient with the right drug," said Williams. "It could eventually become a companion diagnostic, a diagnostic assay that would be run as an adjunct with the drug."
'Within a year'
SkylineDx was established last fall when Van Herk Investments bought the assets, know-how, and IP of Skyline Diagnostics. Skyline Diagnostics, founded in 2005, had developed and introduced AMLprofiler and MMprofiler before going bankrupt in August 2013. Dharminder Chahal, an investment manager at Van Herk, became CEO of the company at that time.
Chahal told BioArray News in September that the company had abandoned earlier plans to seek US Food and Drug Administration clearance for AMLprofiler, but that it would focus instead on making MMprofiler available to US clinicians, given their "strong need" to use its high-risk biomarkers to predict a poor prognosis. Williams' appointment and the opening of the Boston office are part of that strategy.
"The main goals have been to strengthen the commercialization efforts in the US and bring some organization to the commercial team globally for Skyline, to really get our name out to the pharma and labs that might be interested in running the assay," said Williams.
"Within a year, I hope that there will be at least two CLIA labs offering it as a test, that it is on the way to achieving IVD status within the US, and that there will be some pharma companies using it within their pipelines," he said.
Skyline Diagnostics had announced deals with pharma companies in the past. In 2011, it announced deals with Clavis Pharma and Janssen Pharmaceuticals to work on drugs for AML and MM, respectively.
In terms of IVD status, Williams said that SkylineDx does intend to submit MMprofiler to the FDA for clearance so that it can sell the test as a kit, but he declined to forecast when such an event would occur.
One factor that might encourage the adoption of the test is the FDA's recent clearance of Affymetrix's CytoScan Dx assay. While that SNP genotyping-based test is intended for the study of developmental delay and other constitutional abnormalities, some labs are also integrating CytoScan into their cancer cytogenetics research programs.
"Certainly, there could be overlap there," Williams said of the possibility of CytoScan users adopting MMprofiler. "People could do expression on our platform and switch over to do SNP analysis."
Looking ahead, he said that the company is also exploring using a next-generation sequencing approach for its assay, such as RNA-seq, to determine whether it provides higher-quality information. Some other companies that have offered array-based gene-expression diagnostics in the past, such as Progenika, have done just that in recent years.
Still, Williams acknowledged that there are "a lot of questions about economics and throughput that will determine the implementation of NGS."
The company is also running retrospective and prospective studies with MMprofiler to build the amount of data behind the test, and is encouraging professional organizations to recommend the use of gene-expression profiling signatures for stratifying patients, both of which could aid in gaining reimbursement for MMprofiler in the future.
Earlier this month, Skyline said in a statement that the European Myeloma Network had recommended the use of gene expression profiling for the evaluation and treatment of newly diagnosed patients with multiple myeloma. The US National Comprehensive Cancer Network and the International Myeloma Working Group's guidelines similarly state that gene expression profiling is a "powerful and fast tool … to further refine risk stratification," Skyline noted.