PerkinElmer (PKI) Receives EUA from FDA for Latest Assay

·4 min read

PerkinElmer, Inc. PKI recently announced that it has received Emergency Use Authorization (EUA) from the FDA for the PKamp Respiratory SARS-CoV-2-RT-PCR Panel 1 assay. Following this announcement, qualified laboratories can commence using this single test immediately for the simultaneous qualitative identification and differentiation of SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) — separated from nasopharyngeal swabs, anterior nasal swabs and mid-turbinate swabs.

It is worth mentioning that PerkinElmer’s all-inclusive SARS-CoV-2 portfolio comprises high throughput RNA extraction, RT-PCR, workflow automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based antigen along with serology testing.

This announcement is not only likely to provide a boost to PerkinElmer’s product portfolio but also bolster its Diagnostics business.

More on the News

COVID-19, flu and RSV infections, which are highly contagious by nature, can't be distinguished often just on the basis of symptoms. In fact, the U.S. Centers for Disease Control and Prevention encourages COVID-19 testing laboratories to take up a multiplex method that makes detection and differentiation of SARS-CoV-2 and influenza viruses easier.

Per management, this new test will help minimize confusion stemming from similar symptoms that are induced by the aforementioned infections and lessen further strain on the healthcare system amid the pandemic.

Interestingly, PerkinElmer has a CE marking for a multi-analyte respiratory panel that tests for COVID-19. The PKamp Respiratory SARS-CoV-2-RT-PCR Panel assay is cleared to be marketed as an in vitro diagnostic device in above 30 countries on fulfilling the requirements of the European In Vitro Diagnostic Directive.

Industry Prospects

Per a report by MarketsandMarkets, the global multiplex assays market was worth $2.17 billion in 2017 and is estimated to reach $3.35 billion in 2023, witnessing a CAGR of 7.5% during the forecast period (2018 to 2023). Adoption of companion diagnostics for boosting the safety and efficacy of therapies, and the advantages of multiplex assays over conventional singleplex assays are the primary factors driving the market’s growth.

Hence, this announcement comes at an opportune time for PerkinElmer.

Recent Developments

This month, PerkinElmer’s company, EUROIMMUN, announced that it has received the FDA’s EUA for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG). This assay enables the qualitative and semi-quantitative detection of IgG antibodies produced against the SARS-CoV-2 S1 antigen in human serum and plasma.

In September, PerkinElmer completed its buyout of BioLegend for a total consideration of approximately $5.25 billion. The latest buyout, which is historically the largest for the company, is expected to further expand its life science business into high-growth areas like cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation and bioprocessing.

Other Notable Approvals

Some other companies in the medical space that have received regulatory approvals in recent times are Becton, Dickinson and Company BDX, Abbott Laboratories ABT and Thermo Fisher Scientific Inc. TMO.

This month, Becton, Dickinson and Company, also popularly known as BD, received 510(k) clearance for expanded indications from the FDA for the Rotarex Atherectomy System. The device has already been cleared for usage in native arterial vessels and now equipped with the expanded indications can treat peripheral arteries fitted with stents, stent grafts, and native or artificial bypasses.

In September, Abbott received the FDA approval for its Amplatzer Talisman PFO Occlusion System to treat patent foramen ovale (PFO) patients at risk of recurrent ischemic stroke. The next-generation Talisman system builds on the company’s industry-leading Amplatzer PFO Occluder.

Again, in September, Thermo Fisher gained pre-market approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) to detect patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC), who are eligible of becoming candidates for EXKIVITY (mobocertinib).


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