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BioSequence Commences Clinical Trial of OncoDNA's Cancer of Unknown Primary Test


NEW YORK (GenomeWeb) – BioSequence has embarked on a year-long study of OncoDNA's OncoDeep CUP service in Spain, looking to raise the profile of the genomic offering among clinicians, and to strengthen its case for reimbursement.

With a population of 46 million, Spain is one of Europe's larger markets, and one where the adoption of the cancer of unknown primary test could translate into adoption in neighboring Portugal, as well as in Latin America, a region that Valencia-based BioSequence also serves.

While CUP represents a small fraction of cancer cases, typically between 2 and 10 percent, it has a bad prognosis, with a median survival rate of less than a year.

"This is not a common cancer," said Adriana Terrádez, codirector and general manager of BioSequence. "What is very common [is] that the oncologists who detect these types of cancers need more information and they look for these types of solutions."

OncoDNA rolled out OncoDeep CUP earlier this year. The service, which is run in the firm's Gosselies, Belgium-based laboratory, relies on a combination of next-generation sequencing data, as well as immunohistochemistry assays, to not only determine the point of origin for patients with cancer of unknown primary, but to provide data that can be used to select treatments for them. OncoDNA currently charges €2,890 ($3,410) for the service.

BioSequence, a fully owned subsidiary of OncoDNA, recently received the funding to carry out the new study through the Spanish Institute for Foreign Trade and the European Regional Development Fund.

As part of the study, BioSequence will make OncoDeep CUP available to oncologists at 15 sites across Spain, with centers such as GETHI in Barcelona, and hospitals in Valencia, Alicante, and Vilanova, among others aiming to offer the test to an anticipated 100 patients for free over the next year.

Clinicians at the Hospital General Universitario de Valencia are leading the project, which remains open to any patient or organization that meets the inclusion criteria in Spain.

"We want to establish OncoDeep CUP as a standard of care for analysis in these patients," said Terrádez. She added that the company and its partners will complete sourcing of patients before next summer, and will eventually use the analyses to develop additional guidelines for using OncoDeep CUP by the end of 2018.

By devising new guidelines for diagnosing and treating CUP in patients, BioSequence aims to not only benefit patients and improve their outcomes, but to make the case to Spanish authorities that the test is worthy of reimbursement.

"That is part of the reason why we decided to generate this project," said  Terrádez. "Hospitals have to push the public health administration to reimburse the analysis."

Currently in Spain, only a few genomic tests are reimbursed by the state, including tests for hereditary disorders, as well as tests for hereditary breast and ovarian cancer sold by Genomic Health and Agendia. If oncologists find the OncoDeep CUP service useful for diagnosing and treating patients, however, they might advocate for its reimbursement.

"Here in Spain everyone has to pay out of pocket for genomic analysis," said Terrádez. "So this study is a way to offer it for them for free," she said. "It's interesting to us, too," she continued. "By personalizing patients' profiles, we can generate really interesting data to contribute to new guidelines and to position this product not only for public but private insurance reimbursement."

She added that oncologists might find the service particularly useful, as guidelines for treating CUP cases have not yet become standardized.

"OncoDeep is very effective in this sense," said Terrádez. "We check the most important genes that are related to solid tumors, and also the results are delivered very quickly," she said. "This is a more comprehensive option for the oncologists."

OncoDeep CUP is just one of OncoDNA's growing menu of services. Since 2014, it has rolled out OncoDeep for solid tumors, as well as services called OncoTrace and OnceSelect for analyzing liquid biopsies, and another service called OncoStrat&Go that combines the two kinds of offerings. The firm, which currently employs around 50, has been expanding during the past year, and inked distribution deals in the UK, Morocco, and Belarus in recent months. It also secured reimbursement from a number of private British insurers for OncoStrat&Go in September.

"This will help patients all over the world," said Nathalie Bernard, marketing director at OncoDNA of the new clinical trial for OncoDeep CUP in Spain. "CUP is very complicated and patients often have many difficulties in finding the right treatment," she said. "So the results of the study could benefit patients everywhere."

Terrádez said that BioSequence intends to initiate more research and clinical studies with other OncoDNA tests in the future, with similar goals to encourage adoption and reimbursement in its territories.

OncoDNA acquired BioSequence for an undisclosed sum in February as part of its strategy to expand its presence across Europe. BioSequence had served as OncoDNA's exclusive distributor in Spain and Portugal for the two prior years.

"We are completely aligned," said Terrádez said of the two firms. Starting in January, BioSequence will do away with its old name and become OncoDNA Spain and Portugal. The company's staff of seven is also mostly focused on selling OncoDNA products and services.

"Ninety percent of our core business is from OncoDNA," said Terrádez.

OncoDNA announced separately last week that it had added two new cancer centers to its Moncodaneum initiative. The company announced the EU-backed project in January. It has a budget of €10 million and involves placing the firm's OncoKDM software at cancer centers. OncoKDM is a software-as-a-service platform that enables cancer centers to integrate and share genomics data from multiple platforms and approaches.

The Hôpitaux Universitaires de Strasbourg in France and Oncology Center Bydgoszcz in Poland have both joined Moncodaneum, OncoDNA said. Four other "major cancer centers" in Belgium, the Netherlands, Norway, and Spain are also in the process of joining, according to the company.  It declined to name the centers. The company ultimately aims to include about 50 centers across 30 countries in the project.

Bernard said that OncoDNA is currently recruiting Spanish and Portuguese participants via BioSequence. "It's a really big project for us," Bernard said. "The aim is to easily translate biological data into something that oncologists can understand and use to select the right treatment for their patients."