Skyline Diagnostics, a privately held firm based in Rotterdam, the Netherlands, plans to debut its first array-based diagnostic in Europe this year. It expects to introduce the test in the US sometime in 2009, and will follow that with three others tests, according to a company official.
Skyline CEO Henk Vietor told BioArray News this week that the company is in the process of validating and registering the test for acute myeloid leukemia in Europe for an eventual CE Marking, and plans to launch the test there in November.
The company also expects to begin talks with the US Food and Drug Administration about the test this summer and to apply for 510(k) submission in 2009.
The test, which runs on Affymetrix’s GeneChip platform, uses a gene-expression signature to classify patients according to their subtype of AML. AML has eight different subtypes that vary in regards to treatment. Some clinicians currently use fluorescent in situ hybridization to identify the genetic mutations associated with AML.
“Based on the expression patterns, we can determine certain chromosomal aberrations,” Vietor said. “Other features of the array are currently under investigation, and we are looking at direct mutations based on the aberrant expression of certain genes that are associated with AML.”
Most of Skyline’s AML chip development work is being done in conjunction with the Department of Hematology at Erasmus MC University in Rotterdam.
Skyline’s eventual goal is to offer the AML test through its own labs and through external reference labs and diagnostic facilities in Europe at a cost of €2,000 to €2,500 ($3,100 to $3,980) per test, Vietor said.
“Initially we will have centers send their samples to Skyline where a complete analysis will be performed. We are also looking for partners in Europe that will be used as reference labs, so that after a validation process they will perform the work-up of the samples,” he said.
According to Vietor, reference labs that partner with Skyline could hypothetically perform their own analysis in the future, in which case Skyline would only sell them the chips. As for the price, Vietor pointed out that AML is a “very complex, heterogeneous disease,” and that other methods, such as FISH and flow cytometry, that are currently being used to identify the disease are also costly.
A limited number of doctors are involved in this field and that’s why we think it is a nice niche market for a small company like Skyline to operate in.
He added that an array-based approach to identifying the disease would enable clinicians to identify mutations in chromosomal aberrations that are associated with AML in one assay, which existing methods currently cannot do.
According to Vietor, the market for Skyline’s AML test is “relatively small.” According to the National Cancer Institute, 9,000 cases are diagnosed in the US annually. However, he said that this will allow Skyline to enter a market with virtually no competition from other array-based diagnostic firms.
Scientists from Veridex, a Johnson & Johnson company, have published data on using microarrays to diagnose AML in patients. However, Veridex, which has also signed a Powered-by-Affy agreement, has not publicly discussed taking its array to market.
“A limited number of doctors are involved in this field and that’s why we think it is a nice niche market for a small company like Skyline to operate in,” Vietor added.
As Skyline inches closer to launching its first test in Europe, it is also gearing up to talk with the FDA about the AML test this summer. The company does not know yet what criteria the agency will require for a 510(k) submission, nor does it have a clear timeline for when that test will become available in the US. However, it hopes to have an FDA-cleared product available for sale in the US by the end of 2009.
“We anticipate we will start initial talks with the FDA this summer because it is our ambition also to get FDA clearance,” said Vietor. “But our timeline is also dependent on what kind of studies the FDA will require. We expect it to be a regular 510 (k) application, and we hope we can get FDA approval within a year after the European launch.”
He explained Skyline’s US market strategy will mirror its European strategy, and said the company is currently looking for collaborators, such as US-based reference labs and diagnostic facilities. He also said that Affy has been providing assistance, including in some cases performing joint studies with Skyline that could make it easier for the Dutch firm to reach the US market.
“We have actually a longstanding collaboration with Affy,” Vietor said. “We have a Powered-by-Affy deal which was started around 2006, so that was the initial collaboration. We are very enthusiastic about the way they approach these collaborations for smaller companies like Skyline. It has been a very helpful and fruitful relationship.”
For instance, he said that Skyline and Affy have together performed a validation study of the AML test in the US that analyzed bone marrow from patients with AML. In the study, Vietor said that Affy extracted the bone marrow, while Skyline analyzed and compared the samples with those in Rotterdam to determine that the results were similar.
He said this method “proves that the test can be done at two different locations with the same results … [and] will make it easier in the future to close deals with reference labs or diagnostics facilities.”
Vietor added that Skyline and Affy have been collaborating with several reagent suppliers, including Becton Dickinson, Asuragen, and Qiagen. For software development, Skyline collaborates with Crosslinks, also based in the Netherlands, and Paris-based Atos Origin.
Beyond AML, Vietor said Skyline is developing chips for brain tumor diagnosis, multiple myeloma or Kahler’s disease, and acute lymphoblastic leukemia. While he said it is not clear when these tests would launch, the brain tumor chip could become available in Europe in the first half of 2010. That would be followed by the multiple myeloma array and finally the launch of the ALL chip some time in 2011.
Skyline has not discussed the amount of funding that it has amassed to date to support these R&D projects and prospective product launches. In November 2007, the company announced that it had closed a Series A Financing round led by the Erasmus MC Biomedical Fund and Life Sciences Partners, both based in the Netherlands. The company did not disclose how much was raised in the round.
Last month, Skyline receiveda €13 million grant from the Dutch government through the Center of Translational Molecular Medicine, which is located in Eindhoven and awards government funding to Dutch applicants on a project-by-project basis.
According to Vietor, between the Series A financing and the latest grant money, Skyline now has the “room to do all the clinical studies necessary” for its first grouping of diagnostics.