Genomics, a leading gene sequencing company, announced on the 17th that multiple laboratory-developed tests (LDTs) covering cancer screening, diagnosis, treatment, and prognosis have recently passed review by the Taiwan Food and Drug Administration (TFDA). With nine new LDT approvals granted at once, Genomics has rapidly increased its total number of approved LDTs to 10, marking another major milestone in its deployment of next-generation, high-end genetic testing.

Genomics noted that compared with whole-exome sequencing (WES), which is currently widely used in the market but focuses only on protein-coding regions covering about 1%–2% of the genome, the company has taken the lead in fully adopting whole-genome sequencing (WGS), which captures complete genomic information. WGS provides greater data depth and resolution, enabling the simultaneous screening of hundreds of genes in a single test and offering significant advantages across clinical applications such as rare diseases and various inherited metabolic disorders.

Genomics is currently the only biotech company in Taiwan that simultaneously masters both high-throughput sequencing technologies—WGS and WES—and has obtained LDT certification. This unique technological positioning and its clinical certification achievements not only create a high competitive barrier, but are also set to become a key driver of the company’s future growth.

The nine LDTs recently approved by the TFDA include “Precision Cancer 523 Gene Panel (Blood),” “OncoSure 523 Gene Panel (Tissue),” “An-Hu-You Cancer Gene Test,” “OmniScope Whole-Exome Sequencing (WES),” “OmniCore Whole-Genome Sequencing (WGS),” “FMR1 Gene Test,” “SMN Gene Test,” “MPN Gene Test,” and “UGT1A1 Gene Test.” These tests adopt next-generation sequencing (NGS) and single-gene locus sequencing technologies to comprehensively screen genetic variations relevant to oncologic medicine, including single-gene mutations, BRCA genes, multi-gene variants, and cancer drug treatment guidance.

Genomics emphasized that these core product lines target the high-value, high-growth field of precision oncology and diagnostics. In recent years, WGS has become the highest standard in NGS testing. The company’s approval for OmniCore Whole-Genome Sequencing (WGS), covering 629 key genes, represents the industry’s top benchmark. The tests also provide multi-dimensional options aligned with Taiwan’s National Health Insurance reimbursement direction, helping advance precision cancer treatment policies while reducing the financial burden on patients.

In the sequencing field, Genomics was the first biotech company in Taiwan to obtain TAF laboratory accreditation. In 2023, it expanded into the LDT space, developing in-house testing technologies while building its own branded testing services. To date, the company has accumulated 10 approved LDTs, spanning genetic metabolic and rare disease testing, prenatal and neonatal chromosomal and genetic variation testing, cancer screening, diagnosis, treatment and prognosis, as well as companion diagnostics for anticancer drugs and tests for adverse drug reactions or drug metabolism genes. Genomics continues to expand its clinical testing portfolio to capture opportunities in the high-end NGS testing market.

General Manager Chiang Chun-Chi said that genetic testing services enable individuals to better understand their biological “code,” opening a new era of personalized intelligent health—from disease prevention and health management to precision medicine and lifestyle recommendations.

Chiang added that different types of tests deliver distinct functional benefits. In clinical care, for example, cancer patients can analyze tumor genetic mutations to match appropriate targeted therapies or immunotherapies, enabling more precise treatment, improving efficacy, extending survival, and reducing unnecessary side effects. The company ultimately hopes to contribute to the realization of President Lai’s vision of a “Healthy Taiwan.”

Aligned with these trends, Genomics has accelerated its investment in clinical testing in recent years. Through collaborations with domestic and international partners, the company has built diversified service channels, strengthened its core competitiveness, and aims to promote a comprehensive preventive medicine ecosystem across the healthcare, insurance, and wellness industries, positioning itself as a market leader.

Benefiting from steady contributions from instrument distribution, genetic testing services, and various NGS projects, Genomics reported October revenue of NT$48.7 million, remaining at a high level. Cumulative revenue for the first ten months reached NT$537 million, up 33% year-on-year and already surpassing full-year 2023 revenue of NT$517 million. With additional LDT services and overseas revenue contributions, the company is optimistic about its operating performance this year and next, as well as the next two decades of rapid growth driven by whole-genome sequencing (WGS) and proteomics.

Resource: 基因定序大廠基米一口氣通過九項LDTs認證 攻百億美元基因檢測市場