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Sividon Diagnostics to Broaden Reach of EndoPredict Breast Cancer Relapse Test

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NEW YORK (GenomeWeb) – German cancer diagnostics firm Sividon Diagnostics plans to expand its business by taking its EndoPredict breast cancer relapse prognostic test to the US and China.

Sividon, a 2010 spinoff from Siemens Healthcare Diagnostics based in Cologne, has been selling EndoPredict to pathology laboratories in Germany and elsewhere, mostly in Europe. The test combines gene expression profiling on a quantitative real-time PCR platform with standard prognostic factors and received the CE mark in late 2012.

In early 2014, the company, which has grown from an initial eight to about 25 employees, partnered with Myriad Genetics' international subsidiary, granting Myriad exclusive rights to distribute EndoPredict worldwide, with a couple of notable exceptions, including the US and China. 

Last month, Sividon struck an agreement with Chinese-German firm Virchow Laboratories in Shanghai to start offering EndoPredict in China. According to CEO and CSO Christoph Petry, Virchow plans to take the test through China Food and Drug Administration approval so it can be sold to other laboratories in China. "We have pretty high hopes to make this one of the pillars of our revenue," Petry told GenomeWeb. "It's a huge market with little competition at the moment because sending samples out of China is very difficult."

In addition, one of Sividon's key goals for 2016 is to obtain 510(k) approval for EndoPredict from the US Food and Drug Administration, which would allow the company to enter said the US market. The plan is to submit the application before next summer.

Sividon's EndoPredict competes with a number of other breast cancer recurrence tests, in particular Genomic Health's Oncotype DX, but also to a lesser extent Agendia's MammaPrint and NanoString's PAM50.

Later this month at the San Antonio Breast Cancer Symposium, a Sividon collaborator from the UK is scheduled to present results from a new validation study that includes a direct comparison between EndoPredict and Oncotype DX.

Sividon resulted from a management buyout after Siemens Healthcare Diagnostics decided in early 2010 to restructure its molecular diagnostics business and focus entirely on infectious disease.

At the time, Siemens maintained a research group in Cologne — originally from Bayer Diagnostics, which Siemens Medical Solutions acquired in 2006 — that focused on molecular oncology, in particular breast and colon cancer.

After Siemens decided that molecular oncology no longer fit into its strategy, Petry, the group's department head, and three of his colleagues persuaded the company to agree to a buyout. Along with two pathology professors from Charité university hospitals in Berlin, they founded Sividon in the summer of 2010, taking over the lease for the lab facilities and buying all office furniture and laboratory equipment from Siemens.

At Siemens, the group had already developed quantitative RT PCR technology for running multi-gene expression assays in a decentralized setting. "Siemens was never interested in having technology and biomarkers for a reference laboratory, but they were always interested to have this in a kittable form," Petry recalled.

In addition, the researchers had developed a genomic predictor, later called EndoPredict, to estimate the likelihood of metastasis in breast cancer patients undergoing hormone therapy.

The group had also just finished two clinical validation studies of the test, involving about 1,700 patients in total, in collaboration with the Austrian Breast & Colorectal Cancer Study Group. "The day when we got the results from the ABCSG collaboration, which were really good, Siemens made its decision public to bail out of molecular oncology and focus on infectious disease," Petry said.

"We saw the results were really good, better than anything that was on the market at that time, so we decided to shop around for investors, which was not so easy because Siemens had just abandoned the activity right before," he said.

Eventually, the company found three German venture capital investors — KfW, a government-owned development bank; Creathor Venture; and Rheinland Venture Capital — who participated in a single-digit multi-million-euro funding round.

With funding in hand, Sividon commercialized EndoPredict for research use only in 2011, until it received the CE mark at the end of 2012, which allowed it to sell the test for clinical use in Europe and a number of other countries.

EndoPredict is designed for use in newly diagnosed breast cancer patients with tumors that are hormone receptor positive and Her2/neu negative, with or without positive lymph nodes.

The test measures the expression of 12 genes — eight disease-relevant genes and four control genes — and combines the result with tumor size and nodal status to provide a score for the risk of metastasis, which can help doctors decide whether or not to recommend chemotherapy.

The gene expression assay runs on the Siemens Versant kPCR Molecular System, the platform the researchers used to develop the test while still at Siemens and "a rather low-cost, very reliable instrument," according to Petry.

EndoPredict is protected by a patent that has been granted in Europe and is pending in most other countries, including the US.

Unlike Genomic Health, which offers Oncotype DX as a centralized laboratory service, EndoPredict is mostly sold as a kit to local laboratories. This has a number of advantages, Petry said, including short turnaround times and the delivery of test results by local experts. Overall, centralized reference laboratories are "alien to most European health systems," he said, which are used to diagnostic tests being offered as a medical service by physicians. In addition, certain countries, such as China, make it difficult if not impossible to ship patient samples across borders for testing.

Pathology labs can complete EndoPredict in less than a day, Petry said. While such a short turnaround time is not clinically necessary, as there is usually a gap of about a month between surgery and the start of chemotherapy, patients want to know as quickly as possible whether or not they need chemotherapy. As such, "it makes a big difference whether the test result is there after a day or two, or after three weeks," he said.

Currently, EndoPredict is offered by approximately 50 laboratories worldwide, about half of them in Germany. The 2014 distribution agreement with Myriad has already paid off: The test used to be little known outside of German-speaking countries, but "Myriad has now taken it to dozens of other countries," Petry said. While the vast majority of tests are sold as kits, Myriad offers it as a service, performed in its diagnostic laboratory just outside of Munich, to countries where EndoPredict is not yet available.

Reimbursement for the test varies between countries, with France being "on the verge" of introducing breast cancer recurrence testing, the UK's National Health Service currently only paying for Genomic Health's test under a program that ends next March, and certain provinces of Spain covering the test, Petry said.

Switzerland was the first to reimburse for the test on a nationwide basis, starting early this year, initially for a period of three years.

In Germany, Sividon's home market, private health insurance companies pay for the test, but reimbursement from statutory insurers, which cover most of the population, varies, with some reimbursing the test routinely and others on a case-by-case basis. Next year, Sividon hopes to obtain nationwide reimbursement status from statutory health insurance, Petry said.

When insurance does not pick up the tab, patients may need to pay for the test out of pocket, though Sividon has patient assistance programs available in certain countries. While prices charged by laboratories for EndoPredict vary, "it would be fair to say that it is lower than €2,500," Petry said, adding that this is "significantly less expensive" than competing tests.

Besides expanding the reach of EndoPredict, Sividon is developing two additional gene expression-based cancer tests, ChemoPredict and ImmunoPredict.

ChemoPredict aims to predict whether a breast cancer patient treated with anthracycline will benefit from additional treatment with taxane, which Petry said has significant side effects and provides limited survival benefits. Sividon has already completed a validation study and is in the midst of a second, with plans to start commercializing the test beyond 2016, most likely as a research-use-only test initially.

ImmunoPredict, which is earlier in its development, will measure the expression profile of immune system genes in breast cancer patients. The hope is to develop predictive markers, Petry said, and Sividon just completed related research funded under the European Commission's Responsify project.

Sividon is not currently seeking further private investments, funding its growth entirely through revenues, he said.

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