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Abbott's Data From Interim Clinical Study of ID NOW Positive

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Abbott Laboratories (ABT - Free Report) recently released favorable results from a new interim clinical study on its ID NOW COVID-19 rapid test. Data from the study points toward the high sensitivity and specificity of the test within seven days of symptom onset. Notably, the ID NOW rapid molecular test is the most studied among the COVID-19 tests currently available.

The recent results support the earlier data submitted to FDA in March for Emergency Use Authorization (“EUA”) as well as the interim results that Abbott released in its May 21 press release. The recent data also highlights the importance of reliable point-of-care testing which is available in convenient and accessible locations where people can get immediate results.

For investors’ note, in the May 21 press release, the company announced interim analysis of an ongoing multi-site clinical study in urgent-care clinics. The study results indicated that the ID NOW COVID-19 rapid test demonstrated high sensitivity and specificity when compared to two different lab-based polymerase chain reaction (“PCR”) reference methods.

The latest favorable study outcome is expected to be a stepping stone toward strengthening Abbott’s Diagnostic Product business on a global scale.

Significance of the Study Outcome

Per management, the clinical study on Abbott’s ID NOW test reflects its capacity to deliver effective, consistent and reliable performance. Further, availability of a significant body of real-world clinical data supporting the critical role played by ID NOW to identify infection rapidly is an improvement from the situation during the early stages of the pandemic. During the initial phases of the pandemic, the scientific fraternity had to depend on samples and modeling to predict test performance.

The availability of a combination of gold-standard lab-based PCR and accurate and reliable rapid tests like ID NOW is crucial to help reduce the infection risk in society and check the virus’ spread.

Further, Abbott has also provided updates to three studies that were covered in the May 21 press release, which also demonstrate the high sensitivity and specificity of the ID NOW test unlike the lab-based molecular PCR tests.

Notably, the data released by Abbott is also in sync with a study published in the Annals of Internal Medicine. In the journal, researchers from Johns Hopkins illustrated that even the most sensitive lab-based molecular tests can fail to provide accurate results.

Industry Prospects

Per a report by Grand View Research, the global molecular-diagnostics market size 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 progress in molecular diagnostics and the growing prevalence of infectious diseases are likely to drive the market.

Given the market potential, Abbott’s Diagnostic Product business is expected to be significantly boosted by the positive study results.

Notable Developments

Abbott has witnessed a few notable developments in its Diagnostic Product business over the past few months.

The company, in May, received the FDA’s EUA for its molecular test for the COVID-19 for use on its new Alinity m molecular laboratory instrument. Further, in May, the company received the EUA for its SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.

Also in May, Abbott announced that new research published in the Journal of Clinical Microbiology found that its SARS-CoV-2 IgG lab-based serology blood test had high specificity and sensitivity for detecting the IgG antibody in patients within 17 days or more after the onset of symptoms.

Price Performance

Shares of the company have gained 37.4% in the past year compared with the industry’s 7% rise and the S&P 500 composite’s 17.4% growth.

Zacks Rank & Other Key Picks

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

A few other top-ranked stocks from the broader medical space are QIAGEN N.V. (QGEN - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Boston Scientific Corporation (BSX - Free Report) .

QIAGEN’s long-term earnings growth rate is estimated at 17.2%. It currently flaunts a Zacks Rank #1. (Strong Buy). 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 15.5%. It currently carries a Zacks Rank #2.

Boston Scientific’s long-term earnings growth rate is estimated at 10%. The company presently carries a Zacks Rank #2.

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