Quidel Corporation (QDEL) received encouraging news when the U.S. Food and Drug Administration (:FDA) cleared 510(k) for the sale of its AmpliVue Group B Strep Assay.
Quidel's non-instrumented molecular diagnostic test, AmpliVue, employs a novel amplification technology in the form of an easy-to-use, hand-held device.
AmpliVue Group B Strep Assay is the combination of isothermal Helicase Dependent Amplification (:HDA) and Quidel’s expertise in lateral flow technology to detect Group B Streptococcus (:GBS) from antepartum women.
Per the information provided by the Centers for Disease Control and Prevention (:CDC), around 10%–30% of pregnant women carry GBS which can be transmitted to the newborn at the time of delivery.
AmpliVue Group B Strep assay is Quidel's second assay to launch in the hand-held, disposable AmpliVue format. The first was launched earlier this year for the detection of toxigenic Clostridium difficile bacterial DNA.
Quidel received 510(k) clearance from the FDA for the Sofia RSV Fluorescent Immunoassay (:FIA) and the Sofia hCG Fluorescent Immunoassay (:FIA) in Aug 2013. In Sep 2013, Quidel received 510(k) clearance for the Quidel Molecular Influenza A+B assay and the Quidel Molecular RSV + hMPV assay.
Both will be used for the Life Technologies Corp. (LIFE) flagship instrument QuantStudio Dx. QuantStudio Dx offers the advanced capabilities in flexible sample batching needed by higher-volume hospital and reference laboratories.
Quidel currently carries a Zacks Rank #2 (Buy). Another medical device stock worth a look is Cyberonics Inc. (CYBX), which also carries a Zacks Rank #2. Investors may also consider BioLife Solutions, Inc. (BLFS), which carries a Zacks Rank #1 (Strong Buy).