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HeiScreen Preps Liquid Biopsy Breast Cancer Test for Year-End Launch

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NEW YORK (GenomeWeb) — HeiScreen, a German molecular diagnostics company, is moving ahead with plans to introduce a liquid biopsy-based test for breast cancer detection for clinical use by the end of the year.

The company's assay relies on a set of 15 methylation and microRNA markers to determine whether a woman has breast cancer. HeiScreen is in the process of obtaining CE-IVD marking for the test with the aim of making it available to German clinicians later in 2019.

The test is performed by screening a patient's blood sample for the marker set using quantitative PCR combined with methylation analysis. The technique was developed by a research team at University Women's Hospital Heidelberg, and the university recognized its market potential in Germany. Three years ago, HeiScreen was established in Heidelberg to commercialize the test. That process intensified last month with the appointment of Dirk Hessel as CEO. Hessell previously served as CEO of Co.don, a Berlin-based tissue engineering and regenerative medicine company.

"The liquid biopsy market is the future," Hessel said. "If you look at the other diagnostic tools we have in the market, mammography is basically 50 years old, and there hasn't been any innovation in that area while early detection of cancer has always remained the dream for any physician."

Hessel noted that HeiScreen is not trying to replace mammography with its test. "Our test is an add-on to that," he said. "Mammography is still important in the diagnostic process," he said. "Our objective is to use [the] liquid biopsy test much earlier than mammography. That is key to detect breast cancer as early as possible."

While early detection using its panel of methylation and miRNA markers is HeiScreen's first indication, the company envisions expanding its use into therapy monitoring, refining it into a tool for personally tailoring treatment decisions.

"Therapy monitoring is something we can do once we have more data for patients who undergo treatment for cancer," said Hessel. "There are therapies in the market, chemotherapies, that have an accuracy or impact on patients of 20 percent, which is nothing," he said. "You are pumping chemo into women's bodies and it's only working in 1 out of 5 patients, but you don't know because you cannot monitor them closely with mammography," he added. "That's our eventual target – to see if we can monitor that therapy and see if we have to switch therapies."

Hessel noted that these are only plans at the moment. "Our clinical studies have to prove that," he said, "but if we can prove that with our clinical studies that therapy monitoring is possible, it's a big step."

Though HeiScreen is three years old, Hessel said that most of its work to date has been at the university level. He declined to discuss financing though he said the privately held company is well funded at the moment. In the past month, though, with Hessel's appointment, the company has raised its profile significantly by making an announcement about the test that was covered widely in the German media.

According to the company, its assay requires a few milliliters of blood to make a diagnosis and can detect breast cancer in women of any age though it is "particularly beneficial" to women under 50 and those with a high familial risk of breast cancer.

The company also claimed a sensitivity level of between 80 and 90 percent for patients with the disease who were diagnosed with the test.

According to a company statement, the university filed a patent covering aspects of the test in 2016 and obtained funding for test development. Hessel declined to provide details of the company's technology. However, the company said that its marker set was developed over the past decade using a variety of tools, such as TaqMan miRNA arrays and Illumina methylation arrays. Once the researchers settled on a set of markers, they plan to transfer the test to a qPCR platform. It is unclear what platform its test kits will ultimately be deployed or when the test launches.

The company claimed in its statement that over the past year, 900 women have been studied using the test, including 500 women with breast cancer and 400 healthy patients. The latest results of this study showed a sensitivity of 75 percent for the 500 breast cancer patients. Sensitivity for those under age 50 was 86 percent versus 60 percent for those over 50.

The study is ongoing, though, the company noted, and is being carried out at multiple centers, with the goal of ultimately testing 2,000 women. Hessel said that additional cases will be used to confirm the researchers' findings. "Our target is certainly to add more to that, to have more data from our analysis."

As part of the study, investigators are looking at the applicability of the test panel for detecting ovarian cancer, as well. They claimed that results for around 200 patients showed sensitivity of up to 80 percent. The results of the study have not yet been published. However, Hessel said it has already produced "convincing data."

"The test works," said Hessel. "We need additional data, but basically the test is at a very late stage where it can perform analyses, and we have done almost 1,000 patients," he said.

Despite these claims, some industry players are still waiting for more information on HeiScreen's test. Saskia Biskup, CEO of Tübingen, Germany-based CeGaT, which offers a variety of genetic tests, said that while she believes in the idea of applying liquid biopsy tests to detect and monitor cancer, not enough information has been made available about HeiScreen's test, even though the company announced its plans to launch the assay for clinical use by year end.

Biskup expressed caution about the claims being made by HeiScreen and said she would want more data related to the test.

"There is almost no information about this test available yet," said Biskup. "What also concerns me is the specificity for breast cancer. How specific are these markers?" she said. "They also don't say anything about false positives," Biskup added. "We are concerned about what happens if you do this test and you get a positive result."

Hessel acknowledged that the company had not yet made its data public but pledged it would when its study is completed.

While the study progresses, HeiScreen is building a team to support market rollout in Germany. "We are hiring people for all the critical positions to start the commercialization project, the regulatory path, the medical path, the sales path," said Hessel. "We will keep it small and lean and focus on investing in additional data for the test," he noted. "You will see in the next months new data coming out of it because we will get more information," he said.

Once it launches, Germany will be HeiScreen's immediate market. According to the German Center for Cancer Registry Data, breast cancer is the most common cancer in women in Germany, accounting for roughly a third of all cancer cases, and there were around 70,000 cases diagnosed last year.

"We are going to provide select labs with test kits, so that they can perform tests on the samples that come from the physicians' offices," said Hessel. "We will try to make the test available for every patient as soon as possible."

HeiScreen is currently determining how to best approach markets beyond Germany and could rely on partners to sell the test in Europe or in the US. "We'll probably look for partners but it hasn't been decided yet," said Hessel.

Numerous companies and research groups have been developing liquid biopsy tests that can be used for either cancer detection or treatment selection and monitoring. They rely on a variety of technologies to detect markers of interest, including next-generation sequencing. Menlo Park, California-based Grail, which is developing a liquid biopsy test for the early-stage detection of multiple cancers, could be a HeiScreen competitor in the future.

"To be honest, I have been in the industry 25 years and I don't care what the competitors do," Hessel said. "We will focus on our test and try to make it top notch."

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