Quidel Receives FDA Clearance for its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Bordetella Pertussis

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue Bordetella Assay for the detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable to Bordetella pertussis.

Pertussis, or whooping cough, is a very contagious disease caused by the Bordetella pertussis bacteria, which attach to the cilia that line part of the upper respiratory tract where they cause inflammation.¹ Pertussis is spread from person to person through the inhalation of bacteria from an infected person's cough or sneeze. Symptoms, such as a runny nose, low-grade fever, or mild cough usually develop within 5-10 days after exposure, but sometimes appear as long as 3 weeks later. Although whooping cough can cause serious illness in children and adults, it is most dangerous for infants and babies. According to the Centers for Disease Control and Prevention (CDC), about half of infants younger than 1 year of age who get this disease require hospitalization.²

The incidence of pertussis has risen steadily over the last few years.3 Factors that have likely contributed to the increased incidence of pertussis include a decline in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, failure to receive booster shots later in life, and continued circulation of B. pertussis in our population.^4-5

The AmpliVue Bordetella Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 75 minutes. Like all FDA-cleared AmpliVue assays, the AmpliVue Bordetella Assay is CLIA-classified⁶ as moderately complex and does not require the customer to invest in expensive thermocycling equipment. This benefit, plus less laboratory space requirements, can significantly lower a laboratory's cost when adopting new molecular testing methods.

"We are pleased to receive 510(k) clearance for our AmpliVue Bordetella Assay -- our fifth assay in the AmpliVue format. We've shown that we can harness our proprietary HDA technology to develop fast, accurate molecular diagnostic assays with a menu that matters to our customers," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Longer-term, we intend to leverage this technology for other molecular diagnostic applications that will be appealing to significant market segments and potentially to public health agencies worldwide."

Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Bordetella Assay expands to six (6) the list of detectable analytes for which this novel AmpliVue platform now has FDA clearance. These include Pertussis, C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.

References:
1) http://www.cdc.gov/pertussis/about/causes-transmission.html
2) http://www.cdc.gov/pertussis/about/signs-symptoms.html
3) CDC. Provisional Pertussis Surveillance Report. 2013. http://www.cdc.gov/pertussis/downloads/pertussis-surveillance-report.pdf
4) Versteegh FGA, Schellekens JFP, Fleer A, Roord JJ. Pertussis: a concise historical review including diagnosis, incidence, clinical manifestations and the role of treatment and vaccination in management Rev Med Microbiol 2005; 16 (3): 79-89.
5) Atwell JE, Van Otterloo J, Zipprich J, Winter K, Harriman K, Salmon DA, Halsey NA, Omer SB. Nonmedical vaccine exemptions and pertussis in California, 2010. Pediatrics 2013; 132 (4): 624-30.
6) Clinical Laboratory Improvement Amendments of 1988 (CLIA). http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/