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Nucleix Advances Epigenetic Tests for Bladder, Lung Cancers in Europe; Eyes US, China

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NEW YORK (GenomeWeb) – Molecular diagnostics firm Nucleix continues to advance its menu of epigenetic tests for cancer.

The Israeli firm recently announced the results of a multicenter study of its Bladder EpiCheck test in addition to netting €2.5 million ($2.9 million) in EU funding to develop a lung cancer assay.

According to CEO Opher Shapira, while the Rehovot-based company has its sights on courting European laboratories with its new tests, it is also undertaking a trial of its bladder test in the US with the aim of gaining US Food and Drug Administration clearance sometime next year. Its lung cancer screening tool, meantime, might meet a need in China where the disease is prevalent, he said.

"China is an interesting market for us," commented Shapira. "Lung cancer is a big issue since China has a high smoking population, as it's a country where smoking rates didn't decrease," he said. "It's a problem, and there are a lot of places to expand in this area."

As such, Nucleix, from its headquarters in the Middle East, is carrying out a commercialization strategy that could introduce its tests to the European, US, and Chinese markets in the next few years. It marks a transition for a company that was founded a decade ago to bring noninvasive molecular cancer tests to market based on its expertise in assaying DNA methylation changes along with its bioinformatics capabilities.

The company's tests can be run on a variety of commercial real-time PCR platforms and is designed to work with regular laboratory equipment, Shapira noted. Customers assay body fluids, such as urine or blood, for disease-specific DNA methylation changes, with results obtained in about five hours. The company's automated EpiScore software reports results including a quantitative score between 0 and 100 as well as a positive/negative interpretation. A higher score indicates more methylation, and a score of over 60 is considered to be positive for cancer.

The company obtained a CE-IVD Mark for its Bladder EpiCheck test, its first assay to achieve clinical clearance, last year. The test relies on multiplexed real-time PCR to analyze a panel of 15 methylation markers associated with disease recurrence.

In July, the results of a multicenter study of the test were published in the European Urology Oncology journal. Scientists at five urology centers in Europe ran Bladder EpiCheck on 440 patients recruited in the first year of follow-up. They compared the test results to conventional approaches for detecting recurrence, including cystoscopy, cytology, and pathology verification.

As detailed in the paper, Nucleix's test demonstrated a high negative predictive value of 99.3 percent, a sensitivity of 91.7 percent and a specificity of 88 percent. The NPV and sensitivity values excluded patients with low-grade tumors. The results indicate that bladder patients deemed to be cancer-free based on the test results might not have to undergo invasive procedures, reducing patient and healthcare burdens.

Shapira said that the new paper will help raise awareness of Bladder EpiCheck among potential customers, such as the urologists who order the test, as well as the university hospital and service labs that could run it. "There is nothing like a good study from top urologists," said Shapira. "This gives the test credibility. A lot of customers want to see such publications support what the company claims." Looking forward, Shapira said that the company and its partners will continue to collect data on patients and will likely publish additional studies in coming years.

A similar study on Bladder EpiCheck is underway in the US. Shapira said that Nucleix is working with partners at Cleveland Clinic, Vanderbilt University, the University of Washington Seattle, Duke University, and the Princess Margaret Cancer Centre in Toronto among others. Shapira said the company aims to complete the trial by the end of this year and could have a test cleared by the FDA for clinical use by the middle of 2019.

While bladder cancer is considered to be the sixth-leading cancer in the EU and seventh-leading cancer in the US, the disease has received interest from researchers and companies developing molecular tests in recent years, in part because of its high recurrence and the associated high cost of monitoring patients during their lifetime. A team of researchers at Oslo University Hospital reported last year that they were developing a noninvasive, urine-based digital PCR-based test for bladder cancer recurrence, for instance.

"For the life of the patient, it is one of the highest-cost cancers there is," Shapira noted, acknowledging the interest in the area. "There is a great need for urologists" for a noninvasive test, he said.

Nucleix's focus on lung cancer as a second indication should surprise no industry observers, as it continues to be one of the leading cancers in the world. "Lung cancer is the most prevalent cancer, it has the highest rate of mortality, and has well-defined risk groups, yet there is no screening for this group currently," noted Shapira.

The company is moving forward with Lung EpiCheck, a blood-based assay for the early detection of lung cancer. Shapira described the test as being "at the stages of final development," and has run its panel of selected markers against samples to train its algorithm, ahead of validating the panel. Nucleix will embark on a clinical trial to support CE-IVD marking of the kit next year, he said.

The recent EU funding it received should enable it to follow through on those goals. The European Commission granted Nucleix the funding through its European Innovation Council pilot SME Instrument Phase 2 program, which Shapira characterized as "highly selective." He said that the award "confirms the potential" of the firm's technology and noted that Nucleix aims to begin clinical trials of Lung EpiCheck next year. He did not comment on a timeline for achieving FDA clearance for the test.

Beyond its bladder and lung cancer tests, Nucleix has a number of other assays in development, and has publicly acknowledged programs in liver and colorectal cancer, as well as the creation of a pan-cancer test. All the tests are based on real-time PCR and DNA methylation detection. While Shapira did not say when these assays might become available for clinical use, he said that its experience with its bladder and lung cancer tests has provided it with the experience to expedite the launch of other diagnostics.

"In the future we believe our development cycle will shorten as we gain expertise and knowledge," said Shapira. "We have developed a pipeline where we can deliver one test after the other very efficiently."