PerkinElmer, Inc. announced that after a career of more than 20 years at the Company, including the last 12 years as chief executive officer, Robert F. Friel, has decided to retire as chairman and CEO and member of the board of directors as of the end of the Company’s fiscal year on Decembe ... more
FDA Provides Emergency Use Authorization to PerkinElmer for COVID-19 Testing
PerkinElmer, Inc. announced 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.
“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.”
- Emergency Use Authorization
- in-vitro diagnostics
- clinical diagnostics
PerkinElmer announced that its board of directors has named Prahlad Singh president and chief operating officer, effective January 1, 2019. In his expanded position, Dr. Singh will have responsibility for both the Discovery and Analytical Solutions (DAS) and Diagnostics operating divisions ... more
PerkinElmer, Inc. announced the appointment of James M. Mock to senior vice president and chief financial officer (CFO), effective May 1, 2018. Andy Wilson, PerkinElmer’s current senior vice president and CFO, who previously announced his retirement from PerkinElmer, will remain with the Co ... more
Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyngeal swab sampl ... more
The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which manufacturers must collect preclinical and clinical data before th ... more
Agilent Technologies Inc. announced that it has entered into a Cooperative Research and Development Agreement with the U.S. Food and Drug Administration to develop new tools to detect and analyze pathogens in food. The joint R&D effort will also seek to improve DNA-based tools for confirmin ... more
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