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After Korean Clinical Approval for Breast Cancer Prognostic, Gencurix Looks to Asian, US Markets


NEW YORK (GenomeWeb) – After recently receiving clinical approval in its home country for its breast cancer prognostic assay, Korean molecular diagnostics company Gencurix is now setting its sights on other Asian markets and the US, according to a company official.

Eungjo Park, marketing manager for the Seoul-based company, said that Gencurix aims to next year achieve US Food and Drug Administration 510(k) clearance for its GenesWell BCT breast cancer prognostic test, a PCR-based assay that measures RNA biomarkers to predict patient survival rates in relation to chemotherapy.

Meantime, its launch in China and Japan should come by the end of this year, while the firm is in negotiations to also make the test available in several other countries in the region.

"After pre-meeting with FDA earlier this year, we determined the necessary process for getting cleared ... as soon as we finished clinical validation," Park said in an interview.

"We plan to perform analytical and clinical validation and submit [the test] for 510(k) clearance within this year," he said. "Due to the FDA reviewing process, the timeline may change but we estimate and have a goal to complete 510(k) clearance by 2Q 2018," he said.

Markets in Asia are also an immediate draw for Gencurix. Park said the company aims to make GenesWell BCT available "very soon" in multiple Asian countries, and is in discussions with "medical device giants" in China and Japan to launch GenesWell BCT by the end of 2017. The company is also engaged in concurrent negotiations with distributors and agencies serving Malaysia, Singapore, Indonesia, and Vietnam.

Park did not provide a timeline for when GenesWell BCT could become available in those countries.

Founded in 2011, Gencurix currently employees 46 people and is publicly listed on Korea's KONEX exchange. GenesWell BCT took the firm and its partners a decade to develop and is its flagship clinical assay. Gencurix's planned expansion to the US and elsewhere in Asia follows its procural of Korean Ministry for Food and Drug Safety approval to offer GenesWell BCT as a clinical test last fall, making it the first approved in vitro prognostic kit for breast cancer in Korea, Park said.

The test consists of a nine-gene panel run on RNA obtained from formalin-fixed, paraffin-embedded tissues using a real-time PCR system manufactured by Roche. According to the firm, its panel includes five genes associated with proliferation, one associated with immunity, and three reference genes.

The expression of these genes can be used to distinguish low-risk stage I and stage II breast cancer patients who should have a high survival rate without chemotherapy in the ensuing 10-year period, from high-risk patients in the same categories who will likely have a low survival rate without chemotherapy during the same time, Gencurix claims.

More specifically, the assay is intended for patients who are estrogen hormone receptor (ER) positive and human epidermal growth factor receptor (HER2) negative, with metastasis involving fewer than three lymph nodes and who have not received preoperative chemotherapy.

Gencurix offers GenesWell BCT as both a kit and a service out of its molecular diagnostics center in Seoul. The company has been running GenesWell BCT as a service for Korean customers able to order the kit since its clearance in November. However, its availability may differ when it becomes available in the US or in other Asian markets "according to the situation of each country," Park said. He added that the firm does expect to offer GenesWell BCT kits in some of these new markets, as the firm produces them within its own facility.

In order to support the international rollout of GenesWell BCT, Gencurix has focused on validating the test clinically. Last month, a team of researchers led by investigators at Seoul National University, published on the results of a recent study involving breast cancer patients in the journal Scientific Reports.

While acknowledging the existence of a number of genetic assays for predicting breast cancer recurrence, such as Genomic Health's Oncotype DX test, the PAM50 signature commercialized by NanoString Technologies as Prosigna, or Agendia's MammaPrint Breast Cancer Recurrence Assay, the authors stated that these assays in some cases lack an immune response-related component, and that, at least in the case of Agendia's test, provide different results in Asian populations than they do in European ones.

"Notably, the BCT algorithm is a prognostic model that encompasses two major biological processes, cell proliferation and the immune response, both of which are significantly related to the clinical outcome of patients," the authors wrote.

The discovery cohort used to develop the prognostic model described in the paper consisted of 174 patients with HR+/HER2- breast cancer that were treated with adjuvant hormone therapy alone, while 222 patients treated with adjuvant hormone therapy alone and 510 patients treated with adjuvant hormone therapy plus chemotherapy were included in the validation cohort.

In the validation cohort treated with hormone therapy alone, the 10 year rate of distant metastasis in the high-risk group according to the BCT score was 26.3 percent, higher than that in the low-risk group, 3.8 percent. In an internal comparison, the authors found the BCT score provided "better prognostic information about distant metastasis than other prognostic models based on traditional clinicopathological factors," such as the Nottingham Prognostic Index score, or the PREDICT mathematical model.

"Our findings highlight the importance of utilizing expression of immune response-related genes in addition to expression of proliferation-related genes as valuable prognostic factors," the authors said. While stressing the inclusion of GenesWell BCT's immune response gene — BTN3A2 —- they also said that it is "notable" that the test relies on a "relatively small number of genes when compared with the number detected by other multigene assays." Genomic Health's Oncotype DX test, for instance, relies on a 21-gene panel, while PAM50, which measures the expression of 50 genes, and MammaPrint, which profiles 70 genes, are considerably larger.

The findings could help Gencurix gain acceptance for its test in Korea, where the validation study was carried out.

Park noted that the assay does compete with Oncotype DX and Myriad Genetics' Endopredict test in the Korean market, though such tests are not yet widely used as they are not covered by Korea's national health insurance program. "They are expensive for patients and can be a burden," he said.

As the only clinically approved breast cancer recurrence test in Korea, GenesWell BCT is now covered by the national insurance, meaning that it should be able to garner a "considerably high share of the market," Park said.

The company is now looking to carry out similar studies of the test with partners in the US as well as in other Asian countries. As the authors noted in the recent paper, while the genes used to develop GenesWell BCT were derived from microarray datasets obtained from breast cancer patients in Western countries, the model was developed and validated in Asian cohorts.

"Additional large validation studies in other populations are needed to further determine the prognostic performance of the BCT score and to compare its prognostic value with that of other prognostic models based on available commercial multigene assays," the authors wrote.

Looking ahead, the company envisions its assay being used not only as a prognostic, but as a tool for guiding treatment for a variety of breast cancer patients.

"Although the GenesWell BCT was developed to predict the risk of distant metastasis in patients with the breast cancer treated with hormone therapy alone, we also found that GenesWell BCT has a prognostic value in breast cancer patients with adjuvant chemotherapy," Park noted. "GenesWell BCT may help guide decisions about the need for additional adjuvant therapies in patients with early breast cancer."