醫材科技展趨勢 邁向精準診斷新時代





BioGend Therapeutics Co.,Ltd.

BioGend Therapeutics was established in July 2016 with a noble vision to be an innovative solutions provider for holistic medical care to restore bone and joint functions. We are committed to develop regenerative orthobiologic products that fulfill unmet clinical needs. We strive to be a trusted healthcare partner helping people maintain a healthy and active life style.

The project management teams at BioGend Therapeutics are led by seasoned product development managers with team members from different functional areas. Each development project is carefully planned following the phase-gate process for effective and efficient execution. For highly regulated biomedical devices, the expertise in regulatory affairs and pre-clinical and clinical development is essential in order to gain regulatory approval and to realize the potential value of innovative bio-technologies. Through the development of innovative bio-orthopaedic products and the establishment of world class GMP processes, we hope to elevate Taiwan's biomedical industry to a new level.

Phalanx Biotech Group

Phalanx Biotech Group is one of the global four microarray developers, providing genomics services (RUO/LDT/IVD), and genetic testing services in reproductive medicine (prenatal/postnatal CNV tests), population medicine (SNP tests), liver cancer ctDNA Methylation Test as well as scientific research OEM/ODM services.
Phalanx Biotech’s expertise is in expression profiling and genetic analysis which stems from its excellence as an original design manufacturer of gene expression microarrays, CytoOneArray®, targeted chromosomal microarrays, for prenatal and postnatal CNV (copy number variation) test services. Its third-generation chromosomal microarrays can test for more than 500 types of hereditary and congenital disorders.
Apart from that, Phalanx Biotech’s patented SNP technology can be used to assess risk of obesity, cardiovascular disease, Parkinson's disease, cancer, etc. in population medicine. It provides an all-in-one of value at risk for +17 common cancers and +13 chronic diseases by genetic tests from our SNP (single nucleotide polymorphism) microarray for personal health and risk assessment. 

Especially, Phalanx pertains an exclusive patent for Liver ctDNA Methylation Test
for the earliest stages of liver cancer detection - A breakthrough genetic testing development by leveraging DNA methylation markers. The sensitivity and specificity of LiverEDx reach to 84.2% and 83.0%, respectively, with AUC=0.87.

HCmed Innovations Co., Ltd. 


HCmed Innovations focuses on the development of drug-device combination products for inhalation therapy. It develops and manufactures portable vibrating mesh nebulizers that offer a mature customization platform, aiming to enhance drug delivery. This technology enables efficient and reliable nebulization of different types of medication, ranging from small molecule synthetics to large molecule biologics, as either solutions, suspensions or even difficult-to-deliver high viscosity drugs.

By combining the strength of Taiwan’s world-class manufacturing industry and a well-established GMP certified manufacturing facility, HCmed’s products have received approval from multiple international health authorities, with some of them being launched in selected markets. Furthermore, the latest developments embrace the inclusion of more advanced features, such as breath actuation and connectivity in order to improve drug delivery efficacy and reinforce patience adherence.

HCmed is prompt to expand its over-the-counter and combination development to continue bringing significant value to the respiratory field and help all those who require their inhalation treatment.



Applied BioCode


The company develops, manufactures, and commercializes multiplex diagnostic testing products. Applied BioCode is the owner of proprietary ‘Barcoded Magnetic Beads’ (BMB) technology, a bio-barcode realized through semiconductor fabrication. The microscale BMB, with a diameter of human hair, is tagged with immunochemistry or molecular probes, allowing the digital barcode to be easily scanned and accurately identified for a very high number (4,096 barcodes) of biological targets with no ambiguity.

Applied BioCode products focus on the $10 billion molecular diagnostic infectious disease market, with an emphasis on Syndromic Testing, a high value methodology that detects all syndrome causing pathogens, while Applied BioCode offers flexible reporting, at affordable cost. The US FDA 510k cleared assays include BioCode® MDx-3000 system with a 17-plex Gastrointestinal Pathogen Panel (GPP) and a 17-plex Respiratory Pathogen Panel(RPP). The 2 US FDA EUA approved assays include BioCode® SARS-CoV-2 Assay that detects 2 N-genes, and BioCode® SARS-Cov-2 Assay that allows pooled samples of 5 specimens. Applied BioCode continues to develop and commercializes novel syndromic testing options for Fungi, unitary track, women STDs, and bacterial drug resistance. 

Proprietary BMB also applies to wide spectrums of diagnostics outside of infectious disease. Applied BioCode partners with world Pet Diagnostics leader Idexx in vet applications. While food safety, autoimmune diagnostics, allergen testing, liquid biopsy are all in line to roll out through either self development or partnership. 




維致生醫第一項女性精準檢測系列產品「子宮內膜異位症體外檢測技術- Vido Care Endometriosis test」採用非侵入性的血液檢測,擁有媲美黃金診斷標準的侵入式腹腔鏡診斷性能,敏感性及特異性皆逾90%。Vido Care系列產品擁有全球化智慧財產權佈局,專利獲21國保護;已獲歐盟CE認證及ISO13485:2016認證,將於2021年進行歐美臨床收案與驗證。

MedFluid Co., Ltd.


醫流體股份有限公司(MedFluid Co., Ltd.)成立於西元 2019 年 5 月,團隊成員由平均 40 歲以下的成員所組成,是一家年輕且充滿活力的公司。



PlexBio Co., Ltd.


博錸生技多年來鑽研腫瘤基因突變之液態檢體(Liquid Biopsy)自動化檢測平台開發,以實現精準醫療(Precision Medicine)之臨床診斷、癌症早期檢測、動態監控、復發預測與預後評估,為癌症治療提供精準數據,是未來預防醫學治療的主流趨勢。InterlliPlex TM博錸多重肺癌基因檢測平台,使用博錸影像晶元磁片πCodeTM來偵測非小細胞肺癌(NSCLC)的血漿或組織切片檢體中74個DNA突變位點及28個融合位點。此技術可擴展並涵蓋數百個基因突變位點,非侵入式的液態檢體可同時針對大量病患的檢體進行分析。博錸產品主要的銷售歐美、日本、台灣、中國及東南亞各地,為領先業界的體外診斷試劑開發專家。

LumiSTAR Biotechnology, Inc.


昱星生技聚焦於人類誘導式幹細胞(iPSC) 模組之高效能藥物篩檢及毒性測試平台,以及更進一步將此平台技術提供做為個人化、精準化醫療服務之檢測技術。
主要核心技術為生理蛋白指示劑之開發 (genetically encoded tools),可用於細胞生理或特定胞器之長時間追蹤; 以及人類誘導式幹細胞 (iPSC) 相關技術之藥物篩檢應用;並結合光遺傳學工具的設計,提供藥廠及 CRO 公司做大規模的新藥開發及毒性測試。此平台技術另一方面可應用於高效能精準化、個人化醫療之服務,亦為公司發展之重點項目。

Brain Navi Biotechnology


首發的「自動鼻咽採檢機器人」可讓醫護人員不用直接接觸受檢者執行採檢,避免交互感染。機器人可客製化受檢者的鼻咽深度(測量個人鼻翼至耳垂的角度及深度)來抵達個人鼻咽位置而採取足夠檢體及減少異物感。了解臨床的環境需求後,於2020年年底向經濟部提出「零接觸防疫採檢站」- 一站式整合性服務;將採檢轉液(此步驟原本需將檢體運送至實驗室,由醫檢師穿戴防護衣,將檢體移入病毒保存液(UTM))至產生報告精簡於醫療級貨櫃屋內。其內配備完整安全環境:HEPA 系統、紫外線消毒系統、正負壓淨流系統等。「零接觸防疫採檢站」能大力協助受嚴峻疫情困頓的醫護人員,將採檢流程標準化可快速完成檢測並取得正式的核酸檢測報告。

Helios Bioelectronics Inc.




ACT Genomics


▪ 通過美國病理師協會(CAP)認證的實驗室以執行高靈敏度與高特異性之次世代定序(NGS)檢測
▪ 提供藥廠合作夥伴在藥物開發時所需之生物標記物研究、臨床試驗之病患篩選及伴隨式診斷檢測開發
▪ 亞洲基因資料庫,提供藥廠臨床試驗病患轉介服務
▪ 專業生物資訊團隊及醫藥資訊團隊,將複雜的基因資訊轉化為可實行的治療方案,協助醫師在不同治療階段,依據每位病患的基因特性找出最適合的治療策略。


TBG Biotechnology Corp.