FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing

PerkinElmer, Inc.

2020/3/26 16:37



WALTHAM, Mass., March 25, 2020 /PRNewswire=KYODO JBN/ --


PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a

healthier world, announced today that the U.S. Food and Drug Administration

(FDA) has provided Emergency Use Authorization (EUA) for the Company's New

Coronavirus RT-PCR test. Clinical laboratories certified under Clinical Laboratory

Improvement Amendments (CLIA) can immediately begin using this kit to detect

SARS-CoV-2, the virus that causes COVID-19. PerkinElmer's RT-PCR test is marketed

as an in vitro diagnostic (IVD) device by meeting the requirements of the European In

Vitro Diagnostic Directive (IVDD) and is available in over 30 countries worldwide.




(Caption: PerkinElmer's New Coronavirus RT-PCR test)


"Despite the challenging environment, our employees have demonstrated

unwavering commitment over the past two months to combat this global pandemic,"

said Prahlad Singh, president and chief executive officer, PerkinElmer. "The

breadth of PerkinElmer's total workflow solution puts us in a unique position

to rapidly address the needs of our clinical diagnostics customers."


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.


More information can be found on PerkinElmer's official website:





Source: PerkinElmer, Inc.



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Caption: PerkinElmer's New Coronavirus RT-PCR test