코로나바이러스(COVID-19)관련. 퍼킨엘머의 RT-PCR 검사 키트 US FDA에서 긴급사용 승인
퍼킨엘머
2020-03-25 20:42
8170
더 건강한 세상을 위해 노력하는 글로벌 리더인 저희 퍼킨엘머 PerkinElmer, Inc. (NYSE: PKI), 는
24일 미국 FDA에서 퍼킨엘머의 새 코로나바이러스(COVID-19), RT-PCR 진단키트에 대한 긴급사용을 승인했다고 발표했습니다.
CLIA(Clinical Laboratory Improvement Amendments)의 인증을 받은 임상 실험실에서는 즉시 이 키트를 사용하여 코로나바이러스를 일으키는 주 바이러스인 SARS-CoV-2를 감지할 수 있습니다.
퍼킨엘머의 RT-PCR 검사키트는 EU 체외 진단용 의료기기(IVDD - In Vitro Diagnostic Directive) 의 요구사항을 충족하는 동시에
체외 진단(IVD – in vitro diagnostic) 장치로 판매되어 전 세계 30여 개국이 넘는 나라에서 이용할 수 있습니다.
퍼킨엘머의 CEO인 Prahlad Singh는 “어려운 환경임에도 불구하고, 우리 퍼킨엘머 임직원들은 지난 2개월동안 이번 세계적인 전염병에 맞서기 위하여 확고한 의지를 보여줬습니다.” 라고 말했습니다.
“퍼킨엘머의 토탈 워크 플로우 솔루션은 임상 진단 고객의 요구에 빠르게 부합하는 독보적인 위치에 있습니다.”
About PerkinElmer
PerkinElmer enables scientists, researchers and clinicians to address their most critical challenges across science and healthcare.
With a mission focused on innovating for a healthier world, we deliver unique solutions to serve the diagnostics, life sciences, food and applied markets.
We strategically partner with customers to enable earlier and more accurate insights supported by deep market knowledge and technical expertise.
Our dedicated team of about 13,000 employees worldwide is passionate about helping customers work to create healthier families, improve the quality of life, and sustain the wellbeing and longevity of people globally.
The Company reported revenue of approximately $2.9 billion in 2019, serves customers in 190 countries, and is a component of the S&P 500 index.
Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
Factors Affecting Future Performance
This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures.
Words such as "believes," "intends," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements.
Such statements are based on management's current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements.
These factors include, without limitation:(1) markets into which we sell our products declining or not growing as anticipated;(2) fluctuations in the global economic and political environments;(3) our failure to introduce new products in a timely manner;(4) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses;(5) our failure to adequately protect our intellectual property;(6) the loss of any of our licenses or licensed rights;(7) our ability to compete effectively;(8) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes;(9) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services;(10) disruptions in the supply of raw materials and supplies;(11) the manufacture and sale of products exposing us to product liability claims;(12) our failure to maintain compliance with applicable government regulations;(13) regulatory changes;(14) our failure to comply with healthcare industry regulations;(15) outbreaks of communicable diseases such as COVID-19;(16) economic, political and other risks associated with foreign operations;(17) our ability to retain key personnel; (18) significant disruption in our information technology systems, or cybercrime;(19) our ability to obtain future financing;(20) restrictions in our credit agreements;(21) discontinuation or replacement of LIBOR;(22) the United Kingdom’s withdrawal from the European Union;(23) our ability to realize the full value of our intangible assets;(24) significant fluctuations in our stock price;(25) reduction or elimination of dividends on our common stock; and(26) other factors which we describe under the caption "Risk Factors" in our most recent annual report on Form 10-K and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
