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As Biocartis Builds Oncology Pipeline, Its Tests Prove Fast and Accurate in New Evaluations

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NEW YORK (GenomeWeb) – Two studies published this month have favorably evaluated molecular oncology assays on the Idylla platform from Biocartis. The studies, published in the Journal of Clinical Pathology, showed that both tests had high sensitivity.

In one study, an evaluation of Biocartis' Idylla EGFR test in cytological samples from lung cancers, a team of researchers at the University of Naples Federico II's department of public health in Italy demonstrated 100 percent sensitivity compared to standard methods.

The Idylla test also picked up additional EGFR changes not covered by the group's standard TaqMan-based test and required only very small tissue samples.

In the second study, researchers at Chungnam National University in South Korea examined the BRAF V600E Idylla test in the context of thyroid cancer, comparing it to PNA clamping PCR, real-time PCR, and pyrosequencing. That team found sensitivity and specificity of about 99 percent and 100 percent, respectively.

In addition to the performance characteristics, however, speed can be a major draw for the Idylla tests, Giancarlo Troncone, first author on the EGFR study, told GenomeWeb in an email.

The fully automated assays take about 2.5 hours to run. "Patients with advanced-stage lung cancer have median untreated life expectancy of approximately 16 weeks; this time should not be spent waiting for test results," said Troncone.

Indeed, "Laboratories should provide results for the sickest of patients as soon as possible," Troncone asserted, adding, "The Idylla EGFR Mutation Assay technology has the potential to achieve that: it is a cost-effective solution, ensuring accurate and fast detection of all relevant mutations."

The Idylla BRAF Mutation Test is CE marked for detection of BRAF mutations in patients with melanoma, Paola Valente, Biocartis' strategic marketing director, noted in an email. However, studies such as the one in Korea are showing the test can be useful for other types of cancer, such as thyroid and colon.

Biocartis launched a liquid biopsy version of the BRAF test in December of last year after receiving a €1.4 million grant from the Flemish Agency for Innovation by Science and Technology to develop liquid biopsy versions of its solid tumor BRAF and KRAS assays for melanoma and colorectal cancer. And the Idylla BRAF test has already been used in a research-use-only setting to show concordance with tissue in one liquid biopsy study.

The firm is now developing liquid biopsy assays for the detection of KRAS and NRAS/BRAF mutations in plasma samples of colorectal cancer, under a partnership with Merck, that will allow faster access to testing and treatment initiation, Valente said. Also, a liquid biopsy assay detecting EGFR mutation in plasma of lung cancer patients is in the pipeline and first feasibility studies are ongoing.

The EGFR mutation test for lung cancer, meanwhile, was a milestone for the company's oncology menu expansion strategies when it launched this summer.

It is "unique from various perspectives," Valente said, noting that it is "by far the easiest and fastest test for EGFR mutations detection available on the market," detecting a broader range of mutations compared to standard tests and only requiring a small amount of sample.

"We see great potential in Europe, as well as in Asia where EGFR mutations in [non-small cell lung cancer] occur in up to 50 percent of patients," she said. The test could potentially be a solution for large reference centers, where it could "complement current workflows in a versatile, fast and cost-effective way," as well as for regions where accessibility to high-precision EGFR testing is limited or non-existent.

"We expect this test to further boost the growth of our installed base of Idylla instruments in 2016," Valente said.

The firm is also ramping up production in anticipation of growth. In July, Biocartis took a €40 million ($44 million) bank and lease financing facility and €15 million subordinated loan to expand manufacturing capacity for its Idylla diagnostics tests, as previously reported by GenomeWeb.

Published studies, such as the ones in JCP for which Biocartis supplied instruments and assay cartridges, also continue to build a reputation for the Idylla tests.

"Without a doubt, these studies are crucial to demonstrate the high quality of our products and their applications in different cancer types," Valente said, adding that studies are also "key tools to increase trust and confidence in the Idylla molecular diagnostics system and its assays."

Publications can also help to further increase the firm's installed base — which the firm last year guided to surpass 300 by the end of this year — and to grow its footprint worldwide, Valente said.

"Biocartis’ efforts to grow its installed base are driven by diagnostic test menu expansion, which will be gradually translated into increasing cartridge demand from customers," she said.

While the BRAF assay is CE-IVD marked for melanoma, the EGFR mutation assay is currently for research use only. The firm plans to launch the CE-marked EGFR test in 2017, as well as a liquid biopsy version.

In terms of making inroads into the US market, in May Biocartis achieved a first US Food and Drug Administration milestone with Emergency Use Authorization of its Idylla Ebola Virus Triage Test in partnership with Johnson & Johnson affiliate Janssen Pharmaceutica.

To prepare for anticipated US commercialization in 2017, Biocartis’ first objectives are 510k submissions in the second half of 2016 for the Idylla Respiratory Panel and the Idylla Instrument and Idylla Console, Valente said.

Meanwhile, Troncone's lab in Naples will continue to use the Idylla EGFR assays. Although the lab has previously validated several methodologies to process cytological samples including next-generation sequencing, "we are willing to implement Idylla EGFR whenever there is the need to provide results in a very short time," Troncone said, adding that "as modern molecular pathologists, Idylla is our first choice when patients need rapid evaluation for immediate treatment planning."

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