This story was originally posted on June 22.
After a year of trying to sell its flagship AMLprofiler test for acute myeloid leukemia as a kit for use on the Affymetrix GeneChip platform, Skyline Diagnostics has found another way to reach smaller laboratories wary of investing in array equipment.
The Dutch molecular diagnostics firm has struck a deal with the Laboratory for Personalized Molecular Medicine, an international reference lab, to offer AMLprofiler as a service to European labs via LabPMM's facility in Martinsried, Germany. According to Skyline CEO Henk Viëtor, the partnership with LabPMM will carry over to the US market once Skyline secures US Food and Drug Administration clearance for AMLprofiler, as LabPMM also maintains a reference lab in San Diego.
Rotterdam-based Skyline secured a CE-IVD mark for AMLprofiler last year (BAN 3/15/2011). 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 Affy's GeneChip platform, combines "cytogenetics, mutation analysis, and expression analysis" in a single array-based assay, according to the firm's website.
Since receiving the CE-IVD mark, Skyline has sold AMLprofiler as a kit, meaning that labs that had the Affy platform installed could offer it, and labs that did not have the platform would need to acquire one in order to offer the test. But Viëtor told BioArray News that "a lot of hospitals and smaller labs" run fewer than 100 AML samples per year, making it hard to justify the purchase of an Affy platform, which Viëtor said costs around €200,000 (about $250,000).
Another "hurdle" for Skyline was demand for FLT3 mutation testing, which has demonstrated an ability to predict a patient's likelihood to benefit from therapy as well as their risk of experiencing a disease recurrence, Viëtor said. Skyline has been unable to add FLT3 mutations to AMLprofiler for a host of reasons, including a lack of IP covering the mutations, as well as "technical limitations" in securing regulatory clearance for such a test.
"For each mutation, we would have to show the reliability and reproducibility of our test," said Viëtor. "As there are tens of [FLT3] mutations available, we could never get [FLT3 mutation testing] by the regulatory authorizes," he said.
Both issues — smaller labs' lack of interest in buying an Affy system and AMLprofiler's lack of FLT3 mutations — have been "solved" by Skyline's new collaboration with LabPMM, Viëtor said. Now European customers can send their samples to LabPMM for processing. And as LabPMM holds a license to FLT3 gene mutations and offers PCR-based testing for them, the two companies can roll their offerings together as one AML testing service.
According to a statement from the firms, the service's assay menu consists of Skyline's AMLprofiler, and LabPMM's Leukostrat FLT3 and NPM1 Mutation Testing. NPM1 testing is also used to stratify AML patients into high and low risk categories. Samples of patients suspected of AML are collected by courier and shipped to LabPMM's testing facility in Martinsried and the results are reported back to the customer within five working days, the firms said.
'Hope for the Future'
While Skyline looks to win over smaller labs and hospitals with the new service, which became available this month, it is also working on submitting AMLprofiler to the FDA.
Viëtor said that the company will complete a clinical study of AMLprofiler by the end of this year and hopes to obtain clearance for the test sometime next year. In the US, Skyline will offer labs two options: either to invest in the Affy platform and run the test in house or to send samples to LabPMM for processing.
Investing in the Affy platform is justifiable for labs that run more than 100 suspected AML samples per year, said Viëtor. But the company also has been seeking a boost from other molecular diagnostics firms that are developing tests on Affy's platform. So far the FDA has cleared two GeneChip-based tests for clinical use in the US: Roche's AmpliChip CYP450 Test, and Pathwork Diagnostics' Tissue of Origin Test. Many others remain in development (BAN 3/15/2011).
"Labs that invest in an Affymetrix system do hope that new signatures will become available," Viëtor said. "That is their hope for the future." Viëtor added that Skyline has similarly been waiting for other companies to secure CE-IVD marks or FDA clearances for their array-based assays, making it easier to sell AMLprofiler to potential customers, but, so far, that "has not been the case."