Leading rapid diagnostic test solutions provider Quidel Corp. (QDEL) has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its new pregnancy test solution.
The test, called “RapidVue hCG”, is a lateral flow pregnancy immunoassay (a biochemical test) designed for the detection of human Chorionic Gonadotropin (hCG), a hormone produced in pregnancy. It represents Quidel’s fourth product launch in the U.S. in 2010.
The RapidVue hCG test has been classified by the Clinical Laboratory Improvement Amendments (CLIA), the U.S. regulatory standards for all human clinical laboratory testing, as “waived test” for use with urine samples. Waived tests are defined as tests which are approved by the FDA for home use and pose no risk to human health if performed incorrectly.
Due to its dipstick format (dipped into the liquid for testing), RapidVue hCG requires no specimen manipulation to perform tests. The test results are available in just 3 minutes following its use.
RapidVue hCG, which will compete with lower-priced brands, has been positioned for use in the professional medical setting including physician’s offices and laboratories. It is Quidel’s most cost-effective pregnancy test yet.
Quidel develops and markets diagnostic solutions aimed at improving patient outcomes and offering economic benefits to the healthcare system. The company’s products are designed to detect and diagnose a host of critical diseases such as influenza, respiratory syncytial virus (RSV), herpes and thyroid disease.
Quidel posted revenues of $25 million (up 2% year-over-year) in second-quarter fiscal 2010 with test kit maker Diagnostic Hybrids Inc/DHI (acquired by Quidel in Feb 2010 for $130 million) contributing $10.1 million. Worldwide sales of reproductive and women’s health business leapt 37% driven by the DHI acquisition, solid performance from immune and complement product lines and higher pregnancy revenues.
RapidVue hCG is one of Quidel’s exciting new product opportunities that is expected to boost its market share and bottom-line moving forward. The company is currently awaiting FDA clearance for its QuickVue RSV10, an RSV infection diagnostic test intended for use in children under six years of age.
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