Quest Diagnostics' Pharyngitis Test Wins FDA Clearance - Analyst Blog
Diagnostics information services provider Quest Diagnostics Inc.’s DGX Simplexa Group A Strep Direct Kit recently received the FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) moderate-complexity categorization. The Simplexa Group A Strep Direct is a real time polymerase chain reaction (PCR) assay that is used to identify the presence of Group A Streptococcus bacteria in patient’s body, utilizing throat swabs.
Quest Diagnostics is upbeat about the potential of this kit given that Group A streptococcus bacteria are responsible for common infections such as strep throat (pharyngitis), and accounts for 30% of acute pharyngitis cases in children and 20% in adults. Each year, over 600 million are found to be affected by strep pharyngitis across the world.
According to the company, people often exhibit similar symptoms across varied infectious diseases, which make it difficult to diagnose a particular virus solely through clinical observation. Traditionally, throat swab culture or point-of-care testing was used to detect the exact virus responsible for the infection.
Quest Diagnostics encouragingly noted that, Simplexa Direct Strep assay scores over other diagnostic testing procedures as it does not require sample extraction (a chemical analysis technique) to achieve results, thereby saving on time and costs incurred by laboratories conducting such tests.
Moreover, using a proprietary chemistry method, the Simplexa Direct Strep test can produce outcomes in the span of an hour only, compared to conventional culture tests which take up to two days to provide results.
In providing a rapid and reliable diagnosis of pharyngitis, the Simplexa Direct Strep test facilitates prevention of spread of this bacterial infection to others while also allowing administration of proper and timely antibiotics. This helps avert progression to more advanced and potentially life-threatening conditions.
This is in accordance with Quest Diagnostic’s vision to develop tests that will offer useful diagnostic insights, which in turn will enable physicians to take prompt, well informed medical decisions.
In line with its five-point strategy, Quest Diagnostics is currently focusing on high-potential areas such as gene-based esoteric testing for infectious disease, neurological disorders and cancer.
In professional lab services business, Quest Diagnostics signed 6 new collaborations in 2014 that are on track to deliver $40 million in annualized revenues. We are also upbeat about the fact that in the last reported quarter, the company witnessed notable improvement in its infectious disease franchise.
We believe the receipt of the FDA clearance to commercially market the Simplexa Direct Strep test will help the company fetch higher profits from testing services, in the quarters ahead.
Currently, the stock carries a Zacks Rank #2 (Buy). Some other top-ranked medical stocks include Almost Family Inc. AFAM, Chemed Corp. CHE and LHC Group, Inc. LHCG. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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