QIAGEN N.V. (QGEN - Free Report) recently announced its plans to launch its rapid portable test, Access Anti-SARS-CoV-2 Antigen Test. The company expects to make the test available in the fourth quarter of 2020. The company will submit this test for an Emergency Use Authorization to the FDA and also for a CE-IVD registration in Europe. Notably, the company plans to introduce two versions of the test in the United States in the fourth quarter – one for labs and the other for point-of-care use.
For investors’ note, the test has been developed in partnership with the Australian digital-diagnostics company, Ellume. Further, the antigen test is the second test (the previous one was Access Anti-SARS-CoV-2 Total test) that has been developed in collaboration with Ellume, thus extending the partnership.
Notably, both the tests use Ellume’s digital eHub and eStick systems. Further, QIAGEN uses its Access QuantiFERON-TB on the same eHub platform on which it runs both its antigen and antibody tests.
With the latest antigen test under its wings, QIAGEN expects to strengthen its foothold in the global Molecular Diagnostics business.
Significance of the Launch
The antigen test can detect the SARS-CoV-2 antigens in people with active infections in less than 15 minutes (negative results are delivered in 15 minutes and strong positive results in three minutes). Further, the test processes around 30 swab samples per hour on an average, using a small digital detection system. The test, due to its speed and scale of testing, is ideal for use in environments requiring a high volume of fast and accurate test results. The test’s design is an important step toward decentralized mass testing, which the health authorities worldwide have been urgently seeking.
Notably, feasibility tests have demonstrated that the Access Antigen Test comes with a high sensitivity and specificity.
Per management, the antigen test is fast, easy to use and cost-effective. Management also noted that the test is likely to become an important tool to address the current unmet high-volume testing demand for SARS-CoV-2 antigens in cases where time is the top priority. The test is also expected to complement the gold-standard polymerise chain reaction (“PCR”) tests used for detection of active COVID-19 infection.
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 antigen test seems to have been timed well.
Other COVID-19-Related Progress
Of late, QIAGEN has been progressing well with regard to its fight against the pandemic.
The company, in August, launched the QIAseq SARS-CoV-2 Primer Panel for next-generation sequencing (“NGS”) 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.
The company, since the initial phase of the pandemic, has been focused on combating the same by building the most comprehensive portfolio of solutions for testing. QIAGEN’s initiatives include ramping up production of viral RNA extraction for use on itsQIAcube, QIAsymphony and EZ1 platforms, as well as third-party instruments. The company also built a range of PCR 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.
Shares of the company have gained 45.8% in the past year compared with the industry’s 10.6% rise and S&P 500’s 13.9% 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 - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Globus Medical, Inc. (GMED - Free Report) .
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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