Product will initially be launched as a lab service in Europe.
Skyline Diagnostics licensed TrovaGene’s NPM1 technology for addition to its AMLprofiler™ microarray, an in vitro diagnostic for acute myeloid leukemia (AML). Skyline Diagnostics plans to initially offer this product as a laboratory testing service in Europe and will eventually expand to markets outside of Europe.
AML is a cancer of the bone marrow in which the rapid proliferation of abnormal cells interferes with normal blood cell production. The nucleophosmin protein mutation is found in approximately 35% of AML patients and occurs in 50–60% of AML patients with normal karyotypes, according to Skyline.
The NPM1 mutation status is associated with good disease prognosis. The NPM1 mutation is also used as a patient-specific biomarker for monitoring minimal residual disease and early detection of recurrence after treatment, the companies add.
The AMLprofiler in vitro diagnostic test replaces nine separate assays, combining cytogenetics, mutation analysis, and expression analysis in a single three-day microarray-based test. With the AMLprofiler more than 50% of the intermediate risk group of AML patients can be reclassified into either the favorable or the unfavorable risk group, according to Skyline Diagnostics.
With its headquarters and product development in San Diego, TrovaGene has focused on developing tests using its patented transrenal nucleic acid technology. Transrenal DNA (Tr-DNA) and RNA (Tr-RNA) are short nucleic acid fragments from normal cell death that cross the kidney barrier and can be detected in urine.
Skyline Diagnostics develops and markets array-based diagnostic tests using gene signatures for personalized medicine in oncology. Its products, called Profilers, are based on gene expression and provide insight on the prognosis of individual patients.