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After Securing CE-IVD for Debut Hereditary Cancer Dx, Korea's NGeneBio Readies NGS Tests for Launch

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NEW YORK (GenomeWeb) – Fresh from achieving a CE-IVD mark for its flagship next-generation sequencing test for hereditary breast and ovarian cancer, Korean molecular diagnostics startup NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in its home market, while envisioning a 2019 submission to the US Food and Drug Administration.

Moreover, the company is readying a number of new sequencing panels, particularly companion diagnostics for cancer drugs, which NGeneBio considers its primary focus, according to YoungJoon Moon, the firm's director of business development.

"Companion diagnostics is the main business direction of NGeneBio, since it is directly connected to precision medicine, which will lead the healthcare market in the future and is a convergence of diagnostics and biopharmaceuticals," he said.

NGeneBio was established in Seoul in October 2015 as a joint venture between Korea Telecom and Gencurix, another Seoul-based molecular diagnostics company that has developed a PCR-based breast cancer assay. Moon said that NGeneBio's founders were part of a genomics and bioinformatics team within KT, while Gencurix saw the firm as an opportunity to expand to sequencing-based testing.

The company completed GMP, ISO 9001, and ISO 13485 certification of its facilities at the end of 2016.

Last year, NGeneBio introduced its first assay, the BRCAaccuTest, an amplicon-based targeted sequencing panel for mutations in the BRCA1 and BRCA2 genes that are associated with an increased risk of developing breast and ovarian cancers. The company also launched NGeneAnalySys, a sequencing data analysis platform for generating clinical reports. The test was developed for use on Illumina sequencing instruments, such as the MiSeq, MiSeqDx, NextSeq, and HiSeq.

Each kit enables customers to process 23 samples in a single run, along with one control sample. The company claims its amplicon-based approach, coupled with its automated analysis software, allows it to reduce the amount of time it takes to generate a clinical report to roughly two days, opposed to some hybridization-capture approaches that can prolong the process longer than that.

NGeneBio announced last week that it had obtained a CE-IVD marking for the panel and software, claiming to be the "first Asian company" to gain a CE-IVD mark for an NGS test run on Illumina instruments, which allows it to market the test for clinical use in Europe.

Though it is unclear if NGeneBio really is the first, other Asian molecular diagnostics firms have typically sought clearance for clinical use in their home markets for such panels in recent years, as opposed to making a first move into Europe. BGI, for instance, has had several sequencing panels cleared for use by the Chinese Food and Drug Administration. Hangzhou-based Berry Genomics similarly garnered CFDA clearance for a noninvasive prenatal screening test in 2015.

"Most clinical NGS tests approved in China are instruments and in-house lab test assays," unlike NGeneBio's kit and software, which can be run by customers in their own labs, Moon was quick to note. "Therefore, hospitals and commercial labs which provide NGS clinical tests can be our customers." 

Singapore-based Vela Diagnostics has obtained CE-IVD marks for a number of sequencing panels for thyroid cancer, melanoma, colorectal cancer, and non-small cell lung cancer, and other indications. However, Moon noted, those tests are intended for use on Vela's SQ301 system, which is manufactured by Thermo Fisher Scientific. NGeneBio's customers in contrast can be any lab with access to Illumina equipment.

That includes European laboratories in a geography where NGeneBio believes there is a "prospective market opportunity" for hereditary breast and ovarian cancer testing. Moon cited the "Jolie effect" — in reference to actress Angelina Jolie's highly publicized double mastectomy following BRCA testing — that has led to an increase in BRCA genetic testing, including among European labs.

NGeneBio does not yet have a direct presence in Europe, but it will attend Medica, the annual medical industry trade fair, in Düsseldorf, Germany, in November, with the aim of identifying potential partners for making the test available on the continent. A clinical validation of BRCAaccuTest is also planned.

While the CE-IVD mark could help NGeneBio in other markets outside of Europe, where the designation is seen as a sign of quality, the company is focused on obtaining Korean Ministry of Food and Drug Safety clearance later this year. Moon noted that obtaining regulatory clearance for clinical use in the test's home market -- in this case Korea -- is an "essential prerequisite" for being able to export it to other markets, such as other countries in Asia.

NGeneBio also claims to be the first Korean company to go through the MFDS clearance process with a sequencing panel.

Obtaining an IVD clearance from the ministry however is "more time consuming" than gaining a CE-IVD mark, Moon noted. He said that NGeneBio is currently carrying out clinical validation of its debut assay, with the hope of having a Korean MFDS-cleared and CE-IVD-marked test on the market before Medica. But beyond Europe lies the US, a lucrative market that NGeneBio is also eager to enter.

According to Moon, NGeneBio is seeking a CLIA-compliant genetic testing laboratory to partner with in the US to launch its NGS panel and software, ideally during 2018. Should the firm be able to establish successful partnerships, it could file for US FDA clearance the following year, he said.

While NGeneBio moves ahead with its BRCAaccuTest, the company is creating a menu of other products. These include a BRCA test for tumor tissue obtained from ovarian cancer patients; a solid tumor product consisting of an NGS panel and analysis software that tests for multiple genes associated with various tumors; and a blood cancer product for testing multiple genes related to hematological malignancies.

NGeneBio is also preparing a cancer companion diagnostic that will enable physicians to identify patients likely to respond well to PARP inhibitors, such as Tesaro's FDA-cleared drug Zejula (niraparib). Myriad Genetics obtained FDA clearance for the use of its PCR- and Sanger-sequencing-based BRACAnalysis assay as a companion diagnostic for Zejula in March.

All of NGeneBio's planned NGS kits will be bundled with its NGeneAnalySys software as the company works continuously toward its goal to provide the global market with "clinically validated NGS-based IVD and CDx products and services with the convergence of innovative bioinformatics," Moon said. However, the company has not fully articulated its plans for its upcoming assays, including the companion diagnostic.

The company expects to launch those products in the first half of 2018, said Moon. "The regulatory plan is not yet fully decided, but we are planning to enter clinical validation and regulatory body processes for registration in [Europe], Korea and other regions."