Applied BioCode
【GRC投资案例】瑞磁新冠检测试剂 获第2张美国FDA紧急使用授权
21.Dec
2020


导言

瑞磁生技(Applied BioCode)是GRC国富绿景在生物医疗领域的经典投资案例,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,向全球提供高科技的多重检测产品和服务。GRC作为主要投资人参与投资瑞磁生技,并拥有董事席位。公司于2020年6月成功在TWSE挂牌上市(ABC-KY,股票代号6598)。

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全球新型冠状病毒 COVID-19 确诊病例持续增加, 各国医疗防疫系统正面临着巨大挑战。瑞磁生物科技继其日前研发的COVID-19 分子检测试剂取得美国FDA紧急使用授权 (EUA)后,再以合并检测方式 (Pooling Testing) 于12月10日取得了美国 FDA 紧急使用授权。后续新冠肺炎病毒检测数将扩增五倍,即单一仪器每日检测量可从564例扩增到2820例,应用于新冠疫情紧迫的美国。

此外,瑞磁生技的多重检测试剂与系统可在相同的成本价位上,一次性准确鉴别新型冠状病毒COVID-19、其他20种流感症状冠状病毒以及各种流行性感冒病毒。在全球受到疫情冲击、病毒渐趋流感化的当下, 推动多重、高通量、全自动化的分子诊断产品以保护全人类健康福祉, 已是刻不容缓。


Applied BioCode Receives Emergency Use Authorization for Pooled COVID-19 Testing

December 10, 2020 06:49 PM Eastern Standard Time

SANTA FE SPRINGS, Calif.-(BUSINESS WIRE)

Applied BioCode announced today that it has received Emergency Use Authorization (EUA) from the US FDA for the use of its BioCode® SARS CoV-2 molecular diagnostic assay with pooled patient samples*. 

Applied BioCode’s EUA permits the pooled testing of up to five individual specimens from patients suspected of having COVID-19. The BioCode® SARS CoV-2 Assay is run on the automated BioCode® MDx-3000 Molecular System. With “pooled sampling” the system can test 2,820 samples per day.

The FDA is authorizing pooled-sample testing as more efficient than individual testing, meaning that fewer testing supplies are used and more tests can be run at the same time and in most cases, this allows patients to receive their test results more quickly. Pooled testing is most efficient in areas with low prevalence, meaning most results are expected to be negative. As a condition of authorization Applied BioCode has agreed to conduct additional pooled sample testing at three different clinical sites.

“By providing a pooling protocol, we are helping our clinical laboratory customers meet the high demand for accurate high volume molecular test results during the pandemic,” said Applied BioCode’s President Winston Ho, Ph.D. “This amendment to our Emergency Use Authorization for COVID-19 testing from the US FDA for pooling samples will enable more samples to be tested each day, allowing test results get back to patients faster. I am very proud of the accomplishments our team has made in getting these important tests to laboratories in the fight against this virus.”

The BioCode® SARS-CoV-2 Assay is designed to provide accurate results by detecting two different regions of the SARS-CoV-2 virus N gene. The assay can be run as an independent assay or in parallel with our FDA-cleared BioCode® Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.

For more information on the BioCode® SARS CoV-2 Assay, visit: www.apbiocode.com


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 is FDA-510K cleared 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.

* This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.


About GRC

富华资本(即GRC)作为一家专业的私募创投基金管理公司,为世界知名投资机构管理私募创投基金,有限合伙人包括主权基金、全球五百强企业及国际金融机构。 
团队由来自亚洲和美国硅谷创投、科技产业的资深高管组成,具备丰富的行业经验,致力于挖掘并投资颠覆性科技型初创企业,依托广泛的产业及人脉资源网络,助推企业把握全球发展趋势,充分发挥其成功潜力。
富华资本主要关注自主创新的高新技术领域,聚焦初创期、成长期企业,重点投资半导体、关键部件、数字转化、智能基础建设、智能制造、新能源、新材料、生物医疗等战略新兴行业。



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