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PerkinElmer's (PKI) Arm Gets FDA EUA Nod for Latest Assay

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PerkinElmer, Inc.’s (PKI - Free Report) company, EUROIMMUN, recently announced that it has received FDA’s Emergency Use Authorization (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.

This assay can run manually or utilizing the EUROLab Workstation ELISA, Sprinter XL and other third party ELISA platforms.

In fact, clinical laboratories — certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) — can start utilizing this ELISA for the detection of antibodies of the immunoglobulin class G immediately.

It is worth mentioning that the Anti-SARS-CoV-2 S1 Curve ELISA (IgG), which is based on EUROIMMUN’s Anti-SARS-CoV-2 QuantiVac ELISA (IgG) (received CE mark in November 2020), ascertains the concentration of antibodies against the S1 domain of the spike protein that includes the receptor binding domain (RBD), indicating a crucial target antigen for virus neutralizing antibodies.

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

Per management at EUROIMMUN, assays that help in detecting IgG antibodies are a crucial tool for the scientists and researchers who are working toward discovering the nature of SARS-CoV-2 and preventing the spread of other highly infectious viruses in the future.

With the recent EUA, more laboratories will now have the capability to generate detailed insights on immunity that accelerate future antibody therapies and vaccines for COVID-19.

It is important to mention here that the Anti-SARS-CoV-2 S1 Curve ELISA (IgG) is one of the numerous solutions in EUROIMMUN’s SARS-CoV-2 specific profile. This portfolio also comprises real-time PCR tests, an antigen detection assay and multiple antibody tests to name a few.

Industry Prospects

Per a report by Grand View Research, the global antibodies market was estimated at $3.6 billion in 2020 and is projected to witness a CAGR of 6.4% from 2021 to 2028. Hence, this announcement comes at an opportune time for PerkinElmer’s company.

Recent Developments

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.

In August, the company announced the launch of its MaxSignal Mycotoxin Automation Bundle. Using the new assays and automation of this bundle, food safety QA managers and lab teams at grain processors, feed mills, pet food companies and contract labs can accurately and efficiently process up to 180 samples in less than 90 minutes.

Other Notable Approvals

Some other companies in the medical space that have received regulatory approvals in recent times are Abbott Laboratories (ABT - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and QIAGEN N.V. (QGEN - Free Report) .

In September, Abbott received 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).

In August, QIAGEN announced the receipt of EUA from the FDA for its QIAreach SARS CoV-2 Antigen Test. This rapid portable test is designed to address the high-volume testing needs for SARS-CoV-2 antigens.