NGeneBio Obtains CE-IVDR Certification for Breast and Ovarian Cancer Diagnostic Panel

BRCA Diagnostic Panel Meets EU In Vitro Diagnostic Medical Device Regulation
Expanding European Supply and Advancing into South and Southeast Asian Markets

NGeneBio has obtained EU In Vitro Diagnostic Medical Device Regulation (IVDR) certification for its hereditary breast cancer and ovarian cancer diagnostic panel, and is moving to expand its presence in the European and Asian markets.

Song Myungjun, Chief Business Officer (CBO) of NGeneBio's Diagnostic Division (right), and Suh Jungwook, CEO of TÜV SÜD Korea, are posing for a commemorative photo after completing the CE-IVDR certification awarding ceremony for NGeneBio's first domestic breast cancer and ovarian cancer diagnostic products. NGeneBio

On August 11th, NGeneBio announced that it has received CE-IVDR certification, in accordance with the European Union’s In Vitro Diagnostic Medical Device Regulation (EU 2017/746), for its hereditary cancer diagnostic panel, "BRCAaccuTest PLUS."

NGeneBio has already supplied BRCA diagnostic panels to countries including Poland, Türkiye, and Lithuania, based on its previous CE-IVDD certification. The CE-IVDR is a more stringent regulation compared to the previous version, strengthening requirements on clinical evidence, performance evaluation, and quality management.

With this certification, the company plans to expand its current European supply network and increase the provision of hereditary and solid cancer diagnostic products in Western European markets, such as Germany. It will also pursue joint biomarker research with local pharmaceutical companies and medical institutions.

NGeneBio will accelerate its expansion into markets in South Asia and Southeast Asia as well. The company aims to obtain local approvals and boost sales in countries including India, Pakistan, Sri Lanka, Vietnam, Thailand, and the Philippines.

BRCAaccuTest PLUS is a next-generation sequencing (NGS)–based hereditary cancer diagnostic panel. It analyzes multiple mutations in the BRCA1 and BRCA2 genes and is used to assess hereditary cancer risk in patients suspected of having hereditary breast and ovarian cancer syndrome (HBOC).

As a follow-up to the 2017 commercialized "BRCAaccuTest," the new product offers broader detection of mutations and improved analytical accuracy. Its proprietary algorithm processes data 3.6 times faster than the previous product.

NGeneBio’s BRCA diagnostic panels are currently supplied in 11 countries across Europe and Asia. Over the past five years, annual overseas sales of the BRCA diagnostic panels have increased by an average of 57%.

Myeongjun Song, Chief Business Officer (CBO) of NGeneBio’s Diagnostic Division, said, “With this CE-IVDR certification, we will further expand our hereditary and solid tumor portfolio in Western European markets, including Germany, and accelerate entry into new markets such as South Asia and Southeast Asia.”

NGeneBio is also supplying blood cancer diagnostic panels to Germany, Singapore, Colombia, and Vietnam. Overseas sales in the first quarter of this year increased by 102% compared to the same period last year.

This content was produced with the assistance of AI translation services.