Closely-held Spartan Bioscience’s recently launched an on-site rapid DNA test for Legionnaires’ disease that has the potential to eliminate lengthy culture testing in third-party labs and detect the Legionella bacteria ahead of an outbreak of the disease.
“On-site Legionella DNA testing is the first practical way to monitor and prevent Legionella outbreaks in many office buildings, hotels, schools and shopping centers,” Dr. Paul Lem, CEO, says in an interview with BioTuesdays. “With widespread testing, there is the potential to basically eradicate Legionnaires’ disease.”
The Legionella test utilizes Spartan’s coffee-cup-sized, portable DNA analyzer, the Spartan Cube, and single-use disposable test cartridges that can detect and quantify Legionella bacteria in 45 minutes, compared with up to two weeks with conventional cultures. The Cube is the world’s smallest commercial molecular diagnostic device.
Dr. Lem explains that the technology is based on a highly accurate Nobel Prize winning chemistry called quantitative polymerase chain reaction (qPCR) and is designed to meet ISO technical standards. The system won the 2018 AHR Expo Innovation Award for Indoor Air Quality, as judged by the American Society of Heating, Refrigerating and Air-Conditioning Engineers.
Spartan’s product portfolio also includes a test for the CYP2C19 gene mutation, which can impair drug metabolism, and an Alzheimer’s disease risk test cartridge, which is being used by several pharmaceutical companies in clinical trials.
“Our business focus covers medical and non-medical testing, with a pipeline in three categories: pharmacogenetics, infectious diseases and environmental risks,” Dr. Lem points out.
Legionella is a naturally occurring bacterium found in ponds and streams but does not exist in high concentrations in its natural habitat. However, it can become wind borne, infecting cooling towers of heating, ventilation and air conditioning systems of large office buildings and hotels, and providing an ideal environment for the bacteria to grow.
“Infected cooling towers release aerosolized water droplets contaminated with Legionella into the surrounding air,” Dr. Lem says, adding that building occupants who breathe in these water droplets can develop Legionnaires’ disease, a potentially fatal pneumonia.
There are some three million to five million cases of pneumonia in the U.S. each year, with 2% to 9% diagnosed as Legionnaires
There are some three million to five million cases of pneumonia in the U.S. each year, with 2% to 9% diagnosed as Legionnaires. According to the WHO, the mortality rate for Legionnaires is 5% to 10% for non-hospitalized cases and 15% to 20% for hospitalized cases. The CDC also estimates the disease costs the healthcare system $101-million to $321-million a year.
“In the medical system, we do not routinely test for Legionnaires, so the disease is under diagnosed,” Dr. Lem suggests. New York City made testing for Legionnaires mandatory last year.
Legionella acquired its name after an outbreak of a then unknown mystery disease sickened 221 people, resulting in 34 deaths, at a convention of the American Legion in Philadelphia in July 1976. The causative agent was identified as a previously unknown bacterium six months later and named, Legionella.
Currently, Legionella bacterial culture testing of water samples from cooling towers can take up to two weeks, which Dr. Lem contends is too slow because Legionella can reach outbreak levels in as few as seven days.
A CDC study several years ago found that Legionella culture can underestimate actual Legionella levels by a factor of 10 or more. And culture incorrectly reported that water samples were negative for Legionella an average of 11.5% of the time when in fact they were positive.
According to Dr. Lem, buildings with cooling towers should test for Legionnaires weekly. Using the Spartan Cube and disposable test cartridges would cost $5,000-to-$10,000 a year. There are an estimated 150,000 office buildings with cooling towers in the U.S. and 500,000 worldwide, representing a market potential of more than $1-billion. “And that excludes schools, hotels and shopping centers,” he adds.
Spartan has dedicated a 10-person sales team to promote the Legionnaires test to property owners and managers across North America, with Dr. Lem suggesting the size of the team would likely grow because of the “substantial demand we’re seeing. We want to bring the test worldwide because the Europeans also are very interested in Legionnaires testing.”
The Canadian government, through its Public Services and Procurement Canada arm, is currently conducting a study of Spartan’s Legionnaires system against culture testing, as a first step to potentially adopting the test in government buildings across the country.
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