Dutch molecular-test maker Skyline Diagnostics this week received a CE-IVD mark for AMLprofiler, a microarray-based assay for acute myeloid leukemia. The certification will allow the Rotterdam-based firm to offer AMLprofiler to clinicians within the European Union.
Separately, Skyline announced that it has received €1.1 million ($1.5 million) from the Dutch government to support a clinical study of AMLprofiler that will generate data it can use when it seeks US Food and Drug Administration clearance for the test next year.
CEO Henk Viëtor said in a statement that this "substantial financial support" is "instrumental" for Skyline's plans to obtain FDA clearance in 2012. "Only by meeting the FDA's high standards for diagnostic testing, are we able to let leukemia patients worldwide profit from better healthcare based on the results of the AMLprofiler," he said.
Viëtor told BioArray News this week that the company expects to begin enrolling patients in the fall and submit the resulting data to the FDA for review. He said that Skyline has had "several" pre-investigational device-exemption meetings with the agency to discuss a pre-market approval.
AMLprofiler is an in vitro diagnostic that Skyline claims simplifies the recognition of AML subtypes by replacing with one test the approximately eight separate assays currently used by clinicians to monitor the disease.
The diagnostic, which is based on the Affymetrix GeneChip platform, combines "cytogenetics, mutation analysis, and expression analysis" in a single array-based assay, according to the firm.
AML is a cancer of the bone marrow. The Leukemia and Lymphoma Society estimates that about 12,330 Americans will be diagnosed with it this year. There are eight different subtypes of the disease, and the subtype may determine treatment options, according to the society.
Using AMLprofiler, clinicians can reclassify a "significant portion" of the intermediate risk group of AML patients into either the favorable the unfavorable risk categories, "facilitating and improving the clinical decision-making process," Skyline claims.
Skyline began selling AMLprofiler for research use in 2009 (BAN 1/5/2010). The firm originally hoped to achieve CE-IVD marking earlier, and to launch the test by the middle of 2011, but Viëtor said it required additional development.
"The most difficult part of product development was the IT infrastructure, so that we could securely share test results with labs in Japan and the US," said Viëtor. The company offers AMLprofiler both as a kit for labs with an Affy GeneChip Scanner 3000, as well as a service via its lab in Rotterdam.
It is "important to note that the labs can run the test in their laboratory, but the interpretation will be done in our FDA-compliant server environment as a service," Viëtor added.
Since the company has overcome its IT challenges, Viëtor said that Skyline believes it will not take as long to launch assays in the future.
The company has two tests in its pipeline, ALLprofiler, which will allow clinicians to determine the prognosis of acute lymphatic leukemia in children, and MMprofiler, which should aid in the clinical management of multiple myeloma.
Viëtor said that MMprofiler should receive a CE-IVD mark later this year, while Skyline plans to obtain the same certification for ALLprofiler in 2012. However, he said the company has not yet decided whether it will pursue US regulatory clearance for either test.
"In the future, we will develop products for European markets, launch them, see if they are successful, and then will consider a US launch," he said. He said that AMLprofiler had been developed specifically with a US launch in mind.
The firm's effort to win FDA clearance for AMLprofiler is being supported by the "innovation credit" it gained from the Dutch Ministry of Economic Affairs, Agriculture and Innovation last week. Such credits are government-backed advances intended to stimulate development of technologically innovative products, according to the firm.
The planned clinical study for AMLprofiler will involve six academic hospitals in Europe and the US. Viëtor declined to name the firm's partners.
In both the EU and US, Skyline will first target labs that have the Affy system installed, and then will target the "larger state-of-the art service laboratories," Viëtor said.
Skyline last received funding toward its goals in January 2010, when it gained €5 million in a Series B private equity round. Viëtor said at the time that Skyline would require no additional capital investments (BAN 1/5/2010).
This week, he affirmed that no additional funding is needed, "provided we will reach enough sales incomes with the sales of the AMLprofiler." However, Skyline will look for partnerships to "accelerate the growth potential and assist in marketing and sales activities, specifically if we have additional products and products for larger indications," he added.
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Sticking with Affy
Skyline is one of a dozen firms that is developing tests on Affy's array platform. Several companies have already secured regulatory clearance for their tests in the EU and US.
Roche was the first to gain FDA clearance for its AmpliChip CYP450 in 2005. Pathwork Diagnostics has received a number of clearances related to its tumor of origin diagnostic, first launched in 2008 (BAN 6/15/2010). In Europe, Marseille, France-based Ipsogen's oncology prognostic, the MapQuant Dx Genomic Grade, was launched as a service in 2008 (BAN 12/2/2008).
Since the middle of the last decade, though, a number of platforms has become available for complex genetic tests. For instance, Agendia, another Dutch molecular-diagnostics firm, has launched its test on the Agilent Technologies platform. More recently some labs have begun offering tests on next-generation sequencing platforms.
Given these options, Viëtor said that Skyline has continued to develop tests on the GeneChip platform because it has been previously cleared by the FDA for diagnostics use and because it is a "robust, reliable" system.
"If you look at the different technologies available, they are all capable of producing reliable results," Viëtor said. "It doesn't matter if you have Agilent or CapitalBio; many publications have shown [that] results are similar. Affy is a robust, reliable system, with the big advantage that it has already received regulatory clearance for its arrays, reagents, and instrumentation."
Kevin Cannon, vice president of marketing for gene expression applications at Affy, told BioArray News this week that Skyline's recent "success demonstrates advancement in gene expression array applications and further points to the significance and relevance of this technology."
The AMLprofiler "embodies Affymetrix's goal of moving applications downstream from the basic research markets into clinical applications to vastly improve diagnosis and lead to better informed decisions for the most common cancers," Cannon added.
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