Applied BioCode
【GRC投资案例】瑞磁生技推出28种真菌分析物特异性试剂
23.Nov
2021

导言:

Applied BioCode(瑞磁生技) 是GRC在体外诊断(IVD)领域的重点投资项目,公司致力于开发数码液相芯片的尖端分析及医疗诊断技术,向全球提供高效的多重检测产品和服务。GRC作为主要投资人参与投资Applied BioCode,并拥有董事席位。2020年6月,瑞磁生技在TWSE挂牌上市(ABC-KY,股票代号6598)。

原文梗概:

2021年11月22日,瑞磁生技宣布,公司已经发布了28种真菌分析物特异性试剂(ASRs)用于分子测试。(15个ASRs用于霉菌病原体,10个ASRs用于酵母病原体,3个ASRs用于检测二态性真菌)。这些ASRs产品利用公司专有的数位生物条码(BMB)技术对目标生物进行特异性检测。

ASRs可被体外诊断制造商用于开发和验证传染病诊断测试的构建块。试剂检测组织也可用ASRs以达到向患者和从业人员提供诊断信息以外的目的,例如法医,学术,研究和其他非临床实验室。此外,高复杂性实验室可以使用它们来开发自己的实验室开发测试(LDTs)。

"推出真菌ASRs使我们专有的BMB技术更接近美国大多数医院和商业实验室。我们相信,我们针对各种真菌的卓越设计将受到客户的欢迎。"Applied BioCode总裁Winston Ho博士说。


NEWS

Applied BioCode Launches 28 New Fungal Analyte Specific Reagents in the US

November 22, 2021 01:41 PM Eastern Standard Time

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced today that it has released 28 Fungal Analyte Specific Reagents (ASRs) for use in molecular tests. (15 ASRs for mold pathogens, 10 ASRs for yeast pathogens, and 3 ASRs to detect dimorphic fungi). These ASR products utilize the company’s proprietary Barcoded Magnetic Bead (BMB) technology for specific detection of targeted organisms.

For use as building blocks to develop and validate tests for the diagnosis of infectious diseases, ASRs may be sold to in vitro diagnostic manufacturers, and clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), as qualified to perform high complexity testing. *

ASRs may also be sold to organizations that use the reagents to make tests for purposes other than providing diagnostic information to patients and practitioners, e.g., forensic, academic, research, and other nonclinical laboratories. The primer pairs or probes coupled to BMBs are classified as ASRs, which can be used by high-complexity laboratories to develop their own laboratory developed tests (LDTs).

Launching Fungal ASRs brings our proprietary BMB technology closer towards the majority of hospitals and commercial laboratories in the US. We believe that our superior design for a broad range of fungi will be well-received by customers,” said Applied BioCode’s President, Winston Ho, Ph.D.

About Analyte Specific Reagents

The US Food and Drug Administration (FDA) defines Analyte Specific Reagents as “antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents, which through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.” 21 CFR 864.4020

* Under 42 CFR part 493, regulated under VHA Directive 1106 (available from Department of Veterans Affairs, Veterans Health Administration, Washington, DC 20420).

About Applied BioCode

Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products. The company has combined “digital barcodes” with immuno- and molecular chemistry to create a new, bio-inspired Barcoded Magnetic Beads (BMB) technology. The micro BMBs, about the diameter of a human hair, are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned and accurately identified up to 4,096 barcodes with no ambiguity for biological targets. The company has FDA 510K clearances for their Respiratory 17-plex Pathogen Panel and Gastrointestinal 17-plex Pathogen Panel based on their BioCode® MDx-3000 automated system. Applied BioCode also partners with a variety of diagnostic companies with applications that include the infectious disease, autoimmune disease, allergy, gut microbiome, and veterinary markets.


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