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Building on BRCA Test Launch, NGeneBio Rolls Out NGS Panels for Solid Tumors, Hematological Cancers

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NEW YORK (GenomeWeb) – Korean molecular diagnostics company NGeneBio recently introduced two new next-generation sequencing-based panels for cancer and aims to achieve European regulatory clearance for both by year end.

The Seoul-based company also recently raised $1.9 million in series B funding and is targeting between $7 million and $8 million to close the round.

NGeneBio recently gained Korean regulatory approval for its BRCAaccuTest for breast and ovarian cancer, roughly six months after it achieved a CE-IVD mark for the same test, enabling it to offer the panel and accompanying software to clinicians in Europe.

Young Joon Moon, director of business development at the two-year-old firm, said that NGeneBio plans to use the proceeds of its latest round to develop more sequencing-based in vitro and companion diagnostics while it builds a global network for launching its products.

The two latest additions to its menu are called the SOLIDaccuTest and HEMEaccuTest.

The first, SOLIDaccuTest, consists of a DNA panel covering 43 genes and an RNA panel covering 26 genes that can be used to interrogate biopsy tissue and formalin-fixed, paraffin-embedded samples for markers associated with multiple solid tumors, including lung cancer, colorectal cancer, stomach cancer, breast and ovarian cancer, liver cancer, and other diseases.

The second, HEMEaccuTest, targets hematological malignancies, including acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic/myeloproliferative neoplasm, multiple myeloma, and lymphoma, Moon said. It currently consists of a DNA panel covering 99 genes, including genes recommended in World Health Organization, National Comprehensive Cancer Network, and European LeukemiaNet guidelines. NGeneBio will roll out an RNA panel component of the test in the second quarter.

Both panels are designed for use on Illumina instruments, including the MiSeq, MiSeqDx, and MiniSeq platforms, Moon said. They also both rely on the company's NGeneAnalySis software for quality control, variant calling, and clinical report generation, including variant-relevant therapy guidance information, he said.

NGeneBio believes that its amplicon-based approach, together with its automated analysis software, reduces the time it takes customers to render a clinical report to about two days, in contrast to some hybridization-capture approaches that take longer.

Moon said that NGeneBio intends to obtain CE-IVD marks for both new tests by year end. The firm has also commenced consultations with Korean authorities to determine a validation strategy for multigene NGS panels.

In December, the Korean Ministry of Food and Drug Safety approved BRCAaccuTest and accompanying software as a class III in vitro diagnostic, enabling the company to offer it clinically in Korea. The test can be used to detect germline mutations in BRCA1 and BRCA2 genes for breast and ovarian cancer patients, as well as those genetically predisposed to developing the diseases.

The approval carried some significance for NGeneBio, not only because it was the first of its tests to achieve regulatory clearance in Korea following a clinical trial statistically designed for MFDS approval, but because it was the first NGS panel and software to be approved for clinical use in the country to date. The Korean MFDS released a guidance on NGS diagnostics in July 2016, in which it stated that such software also required regulatory oversight.

Moon said that the current market for BRCA testing in Korea is about 10,000 tests per year, making it a roughly $10 million opportunity for the firm. He noted that the number of BRCA tests is "growing quite fast," with a compound annual growth rate of over 30 percent, "in accordance with breast cancer prevalence and incidence increasing."

The country's National Health Insurance Service has reimbursed for BRCA testing since 2012, mostly in breast cancer patients, Moon noted, but he said that demand for BRCA testing has increased among those who might be genetically predisposed to the disease, such as the family members of breast cancer patients. The demand for predisposition testing will "lead the expansion of the BRCA testing market" in Korea, Moon said.

"Major Korean hospitals and commercial labs have considered and employed NGS for clinical purposes since 2016," Moon noted. He added that authorities have certified hospitals for performing clinical sequencing since February 2017, while the Korean Health Insurance Review & Assessment Service set in place a reimbursement program the following month. Both have "led to an increase in the medical community's interest in the introduction of NGS for clinical purposes," he said.

While NGeneBio's status as the first company to gain approval for an NGS kit in the Korean market should help it there, Moon said that will also help the company in other countries, such as China, that mandate tests be cleared in their home market before regulatory authorities will review them. Moon said that NGeneBio will look to adjacent markets such as China and Japan as it expands its business.

"In Asia, the clinical NGS market itself is not huge but an exponentially growing market with high potential, when one takes the expansion of NGS technology and the growing number of cancer patients into perspective," Moon said. China has arguably become the regional leader when it comes to adoption of clinical sequencing tests, driven by uptake of noninvasive prenatal testing.

But selling its tests outside of Korea will require more than regulatory clearance. Moon said that NGeneBio is in the process of setting up distributors in Asia, the Middle East, and Europe, and that it will use the proceeds of its ongoing financing round to build out its international profile.

In addition to entering international markets, Moon said the new financing will enable NGeneBio to launch, validate, and engage in regulatory-related activity for its BRCA, solid tumor, and hematological malignancies tests, as well as focus on new technology development including liquid biopsy tests. The company is also considering establishing subsidiaries and joint ventures to expand its business, he said.

The US is also on the map. Moon said that NGeneBio is "carefully observing the US market" and US Food and Drug Administration guidelines for clinical NGS tests for cancer. He said that NGeneBio will have a booth at the American Association of Clinical Chemistry annual meeting, which will be held this summer in Chicago.

"Other business activities in the US will get started this year as we look to find appropriate business partners," Moon said.