Quidel Receives CLIA Waiver for Its Sofia(R) Diagnostic Test for Respiratory Syncytial Virus (RSV)

SAN DIEGO, CA--(Marketwired - Jun 2, 2014) - Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for its Sofia RSV Fluorescent Immunoassay (FIA) for the rapid detection of respiratory syncytial virus (RSV). 

RSV is responsible for respiratory tract infections, principally among pediatric and elderly populations. In the pediatric setting, almost all children become infected by RSV by their second birthday. The Centers for Disease Control and Prevention (CDC) estimate that in the United States, RSV is responsible for 75,000 to 125,000 hospitalizations annually for bronchiolitis and pneumonia among children younger than one year.¹

Symptoms of RSV infection are often similar to other respiratory infections, and include coughing, sneezing, a runny nose, fever and sometimes a decrease in appetite. Unless diagnostic testing is performed to aid in the diagnosis, RSV infection can be confused with influenza virus infection in young patients.

The simple-to-use Sofia Analyzer and Sofia RSV FIA employ unique software and immunofluorescence-based chemistry to yield an automated, objective and highly reliable result for aiding in the diagnosis of RSV infections within minutes of obtaining the nasopharyngeal swab or nasopharyngeal aspirate specimen from the patient. In addition to the several thousand hospitals, medical centers and smaller clinics in the United States, the receipt of CLIA waiver expands the available point-of-care market for the Sofia test system.

"We are very pleased to receive CLIA waiver for our Sofia RSV assay, and thus gain ready access to the CLIA-waived segment of the market, which includes physician office labs, emergency departments and other CLIA-waived facilities," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Our Sofia system was engineered to be easy-to-use while increasing accuracy and minimizing interpretation and testing errors that are often encountered with other rapid tests. We believe this test will allow healthcare workers in nearly any medical setting to test confidently for RSV and to receive an accurate test result within minutes of the patient's arrival."