QIAGEN (QGEN) to Launch COVID-19 Antibody Test in the US

QIAGEN N.V. QGEN has planned the U.S. launch of its antibody test, Access Anti-SARS-CoV-2 Total test, in late August. The company has submitted this test for an Emergency Use Authorization (EUA) to the FDA. The test, which is an easy-to-use digital test, provides accurate results on Total Ig antibodies (IgA, IgM, IgG).

For investors’ note, the test has been developed in partnership with Australian digital diagnostics company, Ellume. Apart from being submitted for EUA, a CE-IVD marking for Europe and other markets is also in the cards in the upcoming weeks.  First shipments of the antibody test are expected in late August.

With the latest antibody test under its wings, QIAGEN expects to strengthen its foothold in the global Molecular Diagnostics business.

Significance of the Launch

The Access Anti-SARS-CoV-2 Total test, which can be done on a portable device (eHub), provides results in a very short period of time. Notably, the new serological test shows a superior sensitivity and specificity.

Per management, conducting more tests is the only way to assess the magnitude of the pandemic, leading to its control. Serological testing for antibodies is vital in identifying people who have been recently infected by the SARS-CoV-2 virus or had been infected. This is especially important for those who did not show any symptoms and therefore might be unaware of an infection. Antibody testing could also become fundamental in supporting vaccine development as well as for the progress of future SARS-CoV-2 immunization programs.

Rapid lateral flow antibody tests, which are currently available, are unsuitable for the automated and convenient read-out of results. Manual and visual result reporting, and potential snags in read-out timing can lead to uncertain testing results. The Access Anti-SARS-CoV-2 eHub and digital eStick approach aid in mitigating those risks, thus providing reliable results.

Notably, the Access Anti-SARS-CoV-2 platform is also being used for QuantiFERON-TB Access, which is a new solution in development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high TB burden.

Industry Prospects

Per a report by Grand View Research, the global molecular diagnostics market was valued at $9.2 billion in 2019 and is expected to reach $18.2 billion by 2027, at a CAGR of 9%. Factors like increasing prevalence of infectious diseases and technological advancements in molecular diagnostics are expected to drive the market.

Given the market potential, the launch of the antibody seems to have been timed well.

Other COVID-19-Related Progress

Of late, QIAGEN has been progressing well with regards to its fight against the pandemic.

The company recently launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing of the coronavirus genome (the complete set of genes or genetic material present in a cell or organism).

QIAGEN also offers the QIAseqFastSelect rRNA removal technology for research on SARS-CoV-2.

Further, since the initial phase of the pandemic, the company has been focused on combating the same by building the most comprehensive portfolio of solutions for testing. The company's initiatives include ramping up production of viral RNA extraction for use on QIAGEN’s QIAcube, QIAsymphony and EZ1 platforms, as well as third-party instruments. The company also built a range of polymerase chain reaction tests on QIAstat-Dx and NeuMoDx systems and delivered universal NGS solutions for use with any sequencer.

QIAGEN is also scaling up production capacity for reagents sold to other companies for use in their own COVID-19 tests.

Price Performance

Shares of the company have gained 50.3% in the past year compared with the industry’s 13.3% rise and S&P 500’s 19.5% growth.

Zacks Rank & Other Key Picks

Currently, QIAGEN sports a Zacks Rank #1 (Strong Buy).

Other top-ranked stocks from the broader medical space include Hologic, Inc. HOLX, Thermo Fisher Scientific Inc. TMO and Globus Medical, Inc. GMED.

Hologic’s long-term earnings growth rate is estimated at 15.5%. It currently flaunts a Zacks Rank #1. You can see the complete list of today’s Zacks #1 Rank stocks here.

Thermo Fisher’s long-term earnings growth rate is estimated at 15%. It currently carries a Zacks Rank #2 (Buy).

Globus Medical’s long-term earnings growth rate is estimated at 13%. The company presently carries a Zacks Rank #2.

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