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SkylineDx Pact with U of Sao Paulo Could Establish AML Array Test as Standard in South America

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NEW YORK (GenomeWeb) — SkylineDx's collaboration with researchers at the University of São Paulo could lead to the broader adoption of its AMLprofiler test for stratifying acute myeloid leukemia patients in Brazil and beyond.

Rotterdam, the Netherlands-based SkylineDx announced its partnership with investigators at the university's Ribeirão Preto Medical School earlier this month. The researchers aim to evaluate the use of AMLprofiler to improve diagnosis and determine the feasibility of autologous stem cell transplantation as treatment for patients with low or intermediate risk of AML.

The study is expected to last five years and will involve 500 samples from across South America.

Chris Williams, vice president of business development at SkylineDx, told BioArray News that the company sees the project as an opportunity to have its test vetted, and potentially adopted, on the continent, as well as to gain more insight to how it may be used.

"We hope it will lead to acceptance of the AMLprofiler as the primary molecular assay for diagnosis in South America, but also we hope to gain new information into gene abberations in this particular population and correlate those to treatment options," Williams said.

SkylineDx was established last fall when Van Herk Investments bought the assets, know-how, and IP of Skyline Diagnostics, a Dutch molecular diagnostics company. Founded in 2005 and based in Rotterdam, Skyline Diagnostics had developed and launched AMLprofiler and another gene expression-based assay for stratifying multiple myeloma patients for prognosis called MMprofiler before going bankrupt in August 2013.

The company has since opened a North American office in Boston, but has chosen to focus more on selling MMprofiler in the US, citing greater interest in the test, though it still is open to AML-related research partnerships with American customers.

SkylineDx's AMLprofiler relies on cytogenetics, mutation analysis, and expression analysis to subtype patients with the blood cancer. Skyline Diagnostics achieved a CE-IVD marking for AMLprofiler in 2011 and has seen it adopted in Europe and South Africa. The deal with Ribeirão Preto Medical School therefore is the company's first foray into South America.

"We know it is an area we want to focus on as we grow," Williams said of the region. "This was quite opportunistic for us and we did not want to let it pass."

SkylineDx's partners are well positioned to encourage the adoption of AMLprofiler given a favorable outcome of the study. Eduardo Magalhães Rego, a professor of hematology and oncology at the university who is leading the study, is also the Brazilian coordinator of the International Consortium on Acute Leukemias, an initiative of the American Society of Hematology to foster the development of clinical networks in developing countries based on exchanging expertise with well-established groups in US and Europe.

In addition to Brazil, Uruguay, Chile, Mexico, Peru and Paraguay are part of ICAL, and, according to Rego, the new study will be conducted within the framework of the consortium.

Rego told BioArray News this week that he selected AMLprofiler for the ICAL study "because of the range of gene rearrangements and mutations analyzed, the short time needed to get the results ... and the robustness of the test."

Rego described the effort as a "registry study" in which low- and intermediate-risk AML patients will receive as consolidation treatment one cycle of intermediate doses of citarabine followed by autologous stem cell transplant or additional cycles of chemotherapy.

The decision between the two forms of consolidation will be center based, Rego noted. "Our hypotheses is that the autologous transplant will be associated with lower rates of morbidity and mortality, but will have similar antileukemic efficacy compared to chemotherapy," he said. "Our assumption is based on the high prevalence of infections, mainly fungal, in our setting, which frequently leads to death or limits the intensity of consolidation."

In South America today, most centers depend on cytogenetics to classify AML patients, and "since this is not always successful many patients are not properly stratified," Rego said. An exception, he pointed out, is acute promyelocytic leukemia, where RT-PCR and immunofluorescence tests are often used.

According to Rego, it is too early to say whether or not the ICAL study could lead to the adoption of AMLprofiler as the go-to molecular assay in treating AML patients in South America, but that it is "definitely one of the issues to be addressed by this study."

However, there are some challenges to AMLprofiler being successfully adopted in such a way. One question facing Rego and his colleagues is if risk assessment based on AMLprofiler results can reproduce the reported data by the European LeukemiaNet classification, and if the results can be obtained in a timely fashion. Another issue is cost, given the participation of "intermediate income countries" represented within ICAL.

"The ICAL study will provide important clinical and administrative answers concerning AML treatment in Latin America," said Rego.

According to SkylineDx's Williams, the company has already sent staff to Brazil to train Rego's laboratory to run the assay. SkylineDx will also maintain a secure data pipeline to monitor quality metrics during the study and to troubleshoot any problems if needed. As the company's assay is manufactured by Affymetrix and run using Affymetrix instruments, the Santa Clara, Calif.-based vendor will be on hand for any related support queries, Williams said.

While Williams characterized the Brazilian deal as "first of its kind" and "unique" for SkylineDx, especially since it involved samples from across South America, the firm anticipates participating in similar studies in the future.

SkylineDx will likely announce another study, this time using its MMprofiler assay, in the first half of next year. Williams said it would involve researchers in Europe, but declined to further elaborate. He said the company is also working on a number of deals with medical clinical research laboratories and pharmaceutical companies that it may discuss publicly during the next sixth months.

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