PerkinElmer’s COVID-19 RT-PCR Test Kit Receives FDA Emergency Use Authorization for Saliva as Specimen Type
Non-invasive sampling method makes it easier to use the highly sensitive molecular test manufactured by PerkinElmer
WHAT: PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that the U.S. Food and Drug Administration (FDA) has authorized the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit for an additional indication that permits use of saliva as specimen type. The kit now has Emergency Use Authorization (EUA) for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens collected using the SalivaSecure™ Saliva Collection Kit either by a healthcare provider or self-collected under the supervision of a healthcare provider in a healthcare setting from individuals suspected of COVID-19.
HOW: Since the spring of 2020, the PerkinElmer real-time RT-PCR test has been enabling authorized laboratories identify SARS-CoV-2. The kit had previously received EUA for testing anterior nasal, nasopharyngeal, or oropharyngeal swab specimens from any individual, either in single or pooled format. The recently authorized saliva collection from individuals suspected of COVID-19 allows for a non-invasive method of testing that offers more flexibility at collection sites. According to comparative data released by an FDA Reference Panel, the PerkinElmer® New Coronavirus Nucleic Acid Detection Kit has the lowest Limit of Detection (LoD) among the commercially available authorized COVID-19 molecular diagnostic kits reported, making it is the most sensitive commercially available molecular test.
WHY: “As the pandemic lingers amidst emerging variants, testing individuals suspected of COVID-19 continues to be critical,” said Arvind Kothandaraman, general manager of specialty diagnostics at PerkinElmer. “The convenience of using saliva as specimen type ultimately facilitates necessary testing that has proven to be one of the cornerstones for rapid recovery.”
MORE: PerkinElmer helps laboratories combat the pandemic through advanced COVID-19 testing. The Company’s comprehensive SARS-CoV-2 portfolio includes high throughput RNA extraction, RT-PCR, antigen testing, workflow automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
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 14,000 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 $3.8 billion in 2020, 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.
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