(left to right) Dr. Norman Moore, director of research and development; Roger N. Piasio, president and CEO; Joe O’Kelly, director of marketing
Pneumonia is among the most easily treated and cured diseases that a clinician can come across — when it is correctly diagnosed.
However, in the past, pneumonia diagnosis has been a thorny issue. About half of all cases are caused by viruses, while the other half stem from bacteria. Regardless of its origin, most pneumonia patients were given antibiotics, because many of the diagnostic tests to determine the origin of disease were not reliable. Blood culture is useful in only 10 to 30 percent of patients, and sputum culture is known to generate high numbers of both false positive and false negative results. The downside to over-prescribing antibiotics — drug resistant bacterium — was not yet on the radar screen.
Today things have changed. Of the estimated four million cases of pneumonia that occur in the United States each year, half are viral and half are bacterial. Of the two million bacterial cases, about 26 to 30 percent are caused by the Streptococcus pneumoniae bacterium. So in terms of bacterial-associated pneumonia, strep pneumo is No. 1, according to Binax president and CEO, Roger N. Piasio. That’s why Binax developed its Binax NOW Streptococcus pneumoniae Urinary Antigen Test for the physician office and hospital clinical laboratory. The 15-minute NOW assay detects a specific soluble antigen in the urine of patients with pneumococcal pneumonia, allowing doctors to treat the illness with greater specificity.
“The purpose of the test is to assist in controlling, to some extent, the overuse or misuse of antibiotics,” Piasio said. “It’s well known that if you can impart a specific therapy for a specific disease soon enough, the outcome is significant improvement. This benefits patients and the cost system.”
Some might argue that clearly diagnosing just 26 to 30 percent of all bacterial pneumonia cases is not good enough, but Binax would disagree.
“To detect one in five cases and treat with specific antibiotics is a better outcome for patients,” Piasio said. “Why use an elephant gun to go after a fly? Why not target antibiotics to the illness?”
S. pneumoniae is the leading cause of community-acquired bacterial pneumonia in the United States. At least a half million cases of pneumococcal pneumonia occur every year in the United States and many of these cases require hospitalization. If not detected and treated, pneumococcal pneumonia can lead to other illnesses such as meningitis or bacteremia.
The ideal patient for the Binax NOW is anyone hospitalized for pneumonia or who has symptoms of strep pneumo. It is important that the elderly or those with weakened immune systems be diagnosed and treated quickly due to the risk of death from infection if not treated immediately.
The test uses immunochromatographic technology, requiring a urine sample (urinary antigen test) to determine the presence or absence of S. pneumoniae. The test swab is dipped into a patient’s urine, inserted into a small, hand-held card/booklet and the booklet is closed. The appearance of colored lines indicates results in 15 minutes. If the test is negative, a single line appears in the top half of the window near the word, “control.” If the test is positive, two lines appear. If no lines appear, or if only one line appears in the bottom half of the window, the test is invalid and should be repeated.
| Research begins on development of reagents for S. Pneumoniae test | Development of the test format and integration of reagents | Clinical trials conducted | FDA clearance |
| 1995 | 1997 | 1998-1999 | August 1999 |
Given the FDA green light in August 1999, the test achieved 93 percent accuracy in clinical trials. Heading the NOW development effort were Dr. Vladimir Koulchin, senior vice president of research, and Dr. Norman Moore, director of research and development.
Portland, Maine-based Binax began in 1986, doing what small companies do, Piasio said, trying to catch the latest wave in development and find profitable niches to operate in. By 1989, it decided to focus on the causative agents in pneumonia, and Legionella in particular, and the issue of increasing antibiotic resistance in bacterial organisms.
Legionella, the rod-shaped bacteria that causes Legionnaires’ Disease, was first discovered in 1976 when a group of convention-goers at an American Legion meeting in Philadelphia came down with the then-mysterious disease. The problem was eventually traced to the building’s air conditioning system.
In 1990, Binax began developing the capabilities to bring out first-of-their-kind diagnostic tests for infectious disease. The goal was to determine the etiological agent that causes disease due to bacteria in a simple diagnostic procedure.
“The odyssey began in 1991 for the Legionella test, which later gave rise to technology used for the strep pneumo test,” Piasio said.
Watching trends relative to pneumonia published by the Centers for Disease Control in Atlanta, Binax began in 1995 to develop a rapid urinary antigen test for strep pneumo. While the NOW test will make inroads in treating a specific kind of pneumonia, the issue that led to it — Legionella — is nothing to be ignored, Piasio said.
“We had converted the enzyme immunoassay Legionella to a rapid Legionella test,” he said. “It’s estimated that in the United States, there are up to 100,000 cases of Legionnaires’ a year, yet people think of it as an obscure disease.”
“Legionella colonizes in the lungs and causes pneumonia with a high mortality rate, 20 to 50 percent, depending on the state of the patient,” Piasio said. “It’s a bad player.”
“Getting back to strep pneumo, currently, the FDA has only cleared the S. Pneumoniae test for the clinical indication of pneumonia. However, the test is for the detection of strep pneumo, and therefore, can potentially diagnose other disease states where strep pneumo is involved,” Piasio said. “It can colonize in the middle ear, nasal pharyngeal passages and the lung. It’s generally the causative agent for pneumonia in patients with sickle cell anemia. It can be associated with bronchitis. We hope these other clinical indications will materialize in the future so that it’s a generic test. Another application would be for pneumo-related bacterial meningitis, so you can begin to see the utility of the strep pneumo test.”
The media response to the test has been good. “We had the FDA announcement picked up by 100 television stations, and we were in Reader’s Digest in January,” Piasio said. It’s gaining acceptance in the medical community. We’d like it to be faster, but it’s coming. Anytime something is new and changes conventional thinking, it takes time to be accepted.”
