Alere Wins FDA Nod for Strep A Test, Applies for CLIA Waiver - Analyst Blog
Provider of point-of-care diagnostics and services, Alere Inc. ALR recently announced that the U.S. Food and Drug Administration (FDA) has cleared its Alere i Strep A test, which is used to detect Group A Streptococcus (GAS) bacteria in throat swab specimens.
Post the clearance, the company has submitted an application for CLIA (Clinical Laboratory Improvement Amendments) waiver for the Alere i Strep A test. The new test reportedly detects GAS bacteria using Alere's proprietary Molecular In Minutes (MIM) isothermal nucleic acid amplification technology (iNAT).
Alere i Strep A test’s accuracy and speed gives it a competitive edge over other existing lateral flow strep tests. Per management, the tests currently available exhibit accuracy of 90%, while Alere’s test boasts accuracy of 95%–96% in two trials that covered nearly 500 patients.
Interestingly, Alere i Strep A has its own competitors in the molecular diagnostic market. Roche’s cobas Liat System, which includes the cobas Strep A nucleic acid tests among a variety of tests, promises to deliver results in 20 minutes or less. Alere, in comparison, holds that its test can provide results in 8 minutes or less.
In our opinion, Alere’s new test is an interesting addition to the Alere i platform, given the less seasonal nature of Strep A. The company is also developing a number of other assays on the Alere i platform, which include respiratory syncytial virus (RSV), C. difficile and Chlamydia/Gonorrhoea.
We believe Alere’s portfolio expansion is strategically aimed at fueling increased adoption of the Alere i platform. This, once achieved, will help the company gain additional market share and subsequently drive top-line growth.
Of late, Alere has been winning approvals for devices in the pipeline. Last month, the company received IVD CE marking for the Alere q HIV-1/2 Detect assay in Europe. The test is reportedly the first molecular diagnostic at the point of care (POC) that identifies HIV-1 and HIV-2 in less than 60 minutes.
In January, Alere received a waiver from the FDA for its i Influenza A & B test to be used across multiple health care settings. The FDA had first approved the test in Jun 2014 as a prescription-only device, categorizing it as moderately complex and therefore not fit to be used widely.
Zacks Rank
Currently, Alere has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical sector are LeMaitre Vascular LMAT, SurModics SRDX and Capricor Therapeutics CAPR. While both LeMaitre Vascular and SurModics sport a Zacks Rank #1 (Strong Buy), Capricor Therapeutics holds a Zacks Rank #2 (Buy).
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