FDA Expands Use for FilmArray Respiratory Panel

Test is first to detect viral, bacterial causes of respiratory infection from single sample

May 15, 2012 - The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.

The expanded use of the panel adds the bacteria Bordetella pertussis, Mycoplasma pneumoniae and Chlamydophila pneumoniae. The FilmArray Respiratory Panel is the first FDA-cleared molecular diagnostic test able to identify the three bacteria.

Bordetella pertussis is the cause of pertussis, or whooping cough, a serious disease in very young children. Mycoplasma pneumoniae is a common cause of respiratory infection and community-acquired pneumonia, sometimes resulting in large outbreaks, especially in children and young adults. Chlamydophila pneumoniae is a cause of community-acquired pneumonia that can be more serious in older people.

The FDA cleared the FilmArray Respiratory Panel in December 2011 to detect 15 viral causes of respiratory infections. The expanded panel detects two additional forms of the coronavirus in addition to the three bacteria, and now detects a total 17 viruses and three bacteria.

“The expansion of the FilmArray Respiratory Panel to include bacterial causes of respiratory infection is a step forward in the development of multiplex tests that can simultaneously detect several causes of infection,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety at FDA’s Center for Devices and Radiological Health.

The FilmArray Panel detects infections by obtaining a swab sample from the patient’s area where the throat and nose meet (nasopharynx). If a patient has a respiratory infection in other areas of the respiratory tract, additional testing for a suspected respiratory infection may be necessary. The test does not detect all causes of respiratory infection.

Performance of the multiplex panel was determined by studying the test in 1,117 patients with suspected respiratory infections and 467 samples from patients with documented infections.

Molecular-based testing identifies micro-organisms, such as viruses and bacteria, by detecting the presence of their genetic material. For certain viruses and bacteria, molecular-based tests are more sensitive and easier for laboratories to perform than older, culture-based methods of detection. When used in conjunction with other clinical information, molecular tests can result in earlier patient diagnosis and treatment.

Idaho Technology of Salt Lake City manufactures the FilmArray Panel.

For more information:

FDA: Medical Devices
CDC: Pertussis
CDC: Mycoplasma pneumoniae
CDC: Chlamydophila pneumoniae

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.