QIAGEN and DiaSorin Get FDA Approval for LIAISON QFT-Plus

QIAGEN和DiaSorin高通量结核病筛查工具LIAISON QFT-Plus获FDA批准

2019-11-29 10:00:01 Zacks


QIAGEN N.V. QGEN along with biotechnology major DiaSorin announced the commercial launch of QuantiFERON-TB Gold Plus on DiaSorin’s LIAISON platforms in the United States, following the FDA clearance. The LIAISON QFT-Plus Test developed by QIAGEN and DiaSorin will offer streamlined laboratory automation for latent tuberculosis screening.Per QIAGEN’s management, the commercial launch of the LIAISON QFT-Plus Test is a step toward increasing customer adoption of the upgraded version of the test for better disease detection. Notably, the company initiated a partnership with DiaSorin in 2017 to develop tests for the analyzers of the LIAISON portfolio based on QIAGEN’s assay technologies.With the latest FDA approval and subsequent launch of the test platform, QIAGEN aims to strengthen the foothold in the global TB testing market. Notably, QuantiFERON-TB belongs to QIAGEN’s Molecular Diagnostics business.LIAISON QFT-Plus was introduced in Europe in 2018. The launch in China is planned for 2020. Why is the Approval Significant?QFT-Plus is the latest offering in the modern gold standard for latent TB detection tests. It will support the upgradation of the traditional tuberculin skin tests to the modern blood-based QuantiFERON technology, providing a more flexible option for automation to customers.QIAGEN believes that its QuantiFERON-TB Gold (QFT) and QFT-Plus tests are the only less labor-intensive and accurate tests currently available in the market. Per the company, the QFT-Plus tests have the potential of becoming an indispensable part of the medical fraternity by including more measurement parameters.Recent DevelopmentsCurrently, QIAGEN is partnering with two companies dealing with liquid handling solutions to provide options for automated pre-analytical processing for customers that implement the single-tube collection process for QFT-Plus.In October 2019, the company announced that QFT-Plus was included in the diagnostic catalog of Stop TB Partnership’s Global Drug Facility (“GDF”), thus making QIAGEN’s access to countries with higher reported cases of TB easier.In May, the company announced that its QuantiFERON-TB Access will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS). The testing solution was developed by the company in January as an upgraded version of the QuantiFERON-based TB test, customized for areas with lesser resources but higher reported cases of TB.In April, QIAGEN confirmed that its QFT-Plus test was administered to more than 60 million patients.Industry ProspectsPer a report by Research And Markets, the global TB diagnostics market was valued at $2,220.9 million in 2016 and is expected to reach $3,326.9 million by 2025, witnessing a CAGR of 4.5% between 2017 and 2025. Key factors driving the market are the presence of a large patient pool, rising public awareness, and various government and non-government initiatives to eliminate TB.Given the increasing potential of the TB diagnostics market, the approval and the subsequent launch were well-timed.Price PerformanceThe company’s shares have gained 21.1% in the past year against the industry’s decline of 8.2%.Zacks Rank & Key PicksCurrently, QIAGEN carries a Zacks Rank #3 (Hold).Some better-ranked stocks from the broader medical space are Haemonetics Corporation HAE, National Vision Holdings, Inc EYE and ResMed Inc RMD.Haemonetics currently has a Zacks Rank #2 (Buy) and has a projected long-term earnings growth rate of 13.5%.National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently carries a Zacks Rank #2. (Strong Buy) stocks here.ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently flaunts a Zacks Rank #1.Breakout Biotech Stocks with Triple-Digit Profit PotentialThe biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.See these 7 breakthrough stocks now>>
QIAGEN N.V . QGEN 和生物技术大公司 DiaSorin 在 FDA 批准后,宣布在 DiaSorin 的 LIISON 平台上推出 QuantiFEron-TB Gold Plus 。QIAGEN 和 DiaSorin 开发的 LIISON QFT-Plus 测试将为潜在的结核病筛查提供简化的实验室自动化。根据 QIAGEN 的管理层, LIISON QFT-Plus 测试的商业化发布是向客户提供更好的疾病检测升级版本的测试的一个步骤。值得注意的是,公司于2017年与 DiaSorin 发起合作,开发基于 QIAGEN 检测技术的 LIISON 产品组合分析仪测试。随着 FDA 的最新批准及后续试验平台的推出, QIAGEN 旨在巩固在全球结核病检测市场的立足点。值得注意的是, QuantiFEron-TB 属于 QIAGEN 的分子诊断业务。LIISON QFT-Plus 于2018年在欧洲推出。计划于2020年在中国启动。 为什么审批很重要?QFT-Plus 是现代潜在性结核病检测标准的最新产品。它将支持传统的结核菌素皮肤测试升级到基于血液的 QuantiFEron 技术,为客户提供更灵活的自动化选择。QIAGEN 认为,其 QuantiFEron-TB Gold ( QFT )和 QFT-Plus 测试是目前市场上仅有的劳动力密集程度较低且准确的测试。就公司而言, QFT-Plus 测试通过包含更多的测量参数,有可能成为医学联谊会不可或缺的一部分。最近的发展目前, QIAGEN 正与两家处理液体处理解决方案的公司合作,为实施 QFT-Plus 单管收集流程的客户提供自动化的分析前处理选项。2019年10月,公司宣布将 QFT-Plus 纳入 StopTB Partnership 全球药品基金(“ GDF ”)的诊断目录,从而使 QIAGEN 更容易进入报告结核病病例较高的国家。5月,该公司宣布其 QuantiFEron-TB 准入将得到联合国艾滋病毒/艾滋病联合方案( UNAIDS )的承认。该测试解决方案由该公司在1月份开发,作为基于 QuantiFERON 的结核病测试的升级版本,针对资源较少但报告的结核病病例较高的地区进行定制。今年4月, QIAGEN 证实其 QFT-Plus 试验已应用于超过6000万患者。行业前景根据研究与市场部的报告,2016年全球结核病诊断市场的价值为22.209亿美元,预计到2025年将达到33.269亿美元,2017年至2025年的复合年增长率为4.5%。推动这一市场的关键因素是大量患者的存在、公众意识的提高以及政府和非政府采取的消除结核病的举措。鉴于结核病诊断市场的潜力越来越大,批准和随后的上市时机已经成熟。价格表现该公司股价在过去一年中上涨了21.1%,而该行业的跌幅为8.2%。Zacks Rank & Key Picks 目前, QIAGEN 拥有 Zacks Rank #3( Hold )。从更广泛的医疗领域来看,一些排名较好的股票是 Haemonitics Corporation HAE 、 National Vision Holdings 、 Inc EYE 和 ResMed Inc RMD 。目前, Haemonitics 的 Zacks 排名第二(购买),预计长期收益增长率为13.5%。National Vision 的长期盈利增长率估计为17.8%。该公司目前排名第二.这里的股票。ResMed 的长期收益增长率估计为12.9%。它目前炫耀的 Zacks 排名第一。生物技术板块有望在2024年突破7750亿美元,因为科学家们正在开发治疗数千种疾病的方法。他们还找到了编辑人类基因组的方法,从字面上消除我们对这些疾病的脆弱性。Zacks 刚刚发布的世纪生物学:7生物技术股票购买权利现在,以帮助投资者从7个股票盈利准备好跑赢。我们最近的生物技术推荐在短短一个月内就实现了+98%、+119%和+164%的增长。本报告中的股票可能表现更好。现在看这7只突破性股票>