PKI – PerkinElmer (PKI) Receives FDA EUA for Asymptomatic Testing

PerkinElmer, Inc. (PKI Free Report) recently announced the receipt of Emergency Use Authorization (EUA) from the FDA for its New Coronavirus Nucleic Acid Detection Kit. The New Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR test intended to test individuals without symptoms or other reasons to detect COVID-19 infection.

With this approval, clinical laboratories that are certified under Clinical Laboratory Improvement Amendments (CLIA) can now start utilizing this kit to test both symptomatic and asymptomatic individuals.

Through this approval, PerkinElmer will strengthen its portfolio of testing solutions and expand its global diagnostics market reach.

Significance of the Approval

With the emergence of new strains of coronavirus that are even more contagious, the demand for testing is on the rise. The company’s New Coronavirus Nucleic Acid Detection Kit is a real-time RT-PCR test that has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, making it the most sensitive assay which can now test both symptomatic and asymptomatic individuals.

Per research by the Centers for Disease Control and Prevention, almost 60% of total COVID-19 transmissions come from those who show no symptoms. For asymptomatic carriers, diagnostic testing plays a vital role, helping identification and isolation of infectious individuals.

In terms of market reach, PerkinElmer is one of the few suppliers to have an EUA for asymptomatic testing along with a strong supply chain and the capability to do sample pooling, save time and resources for diagnostic laboratories. Moreover, the testing ability to quickly identify asymptomatic individuals delivers significant public health value.

Recent Developments in COVID-19 Testing Space

In December 2020, PerkinElmer launched the CE mark EURORealTime SARS-CoV-2/Influenza A/B for direct detection of SARS-CoV-2, influenza virus type A and type B. It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu.

In the same month, PerkinElmer launched the CE marked SARS-CoV-2 Antigen ELISA for specific determination of the SARS-CoV-2 protein. The launch strengthens the company’s broad product portfolio for COVID-19 diagnostics and supports the molecular PCR tests to diagnose acute SARS-CoV-2 infections.

Industry Prospects

Per a report by Fortune Business Insights, the global COVID-19 diagnostics market size stood at $6.22 billion in 2019 and is anticipated to reach $11.40 billion by 2027, at a CAGR of 7.9%. Uncontrolled spread of coronavirus worldwide is the major factor driving the market. Moreover, the development of real-time test, robust WHO recommendations to make COVID-19 diagnostic a top priority and rising government initiatives targeted toward the implementation of mass testing are fuelling the market.

Price Performance

Shares of the company have gained 46.5% in a year’s time compared with the industry’s growth of 28.6%.

Zacks Rank and Other Key Picks

Currently, PerkinElmer carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks from the broader medial space include AdaptHeath Corp. (AHCO Free Report) , Quidel Corporation (QDEL Free Report) , Meridian Bioscience Inc. (VIVO Free Report) , each sporting a Zacks Ranks #1 (Strong Buy). You can see the complete list of Zacks #1 Rank stocks here.

AdaptHealth has a projected long-term earnings growth rate of 720%.

Quidel has a projected long-term earnings growth rate of 25%.

Meridian Bioscience has a projected long-term earnings growth rate of 13%.

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