ROCKVILLE, Md., Oct. 29, 2018 /PRNewswire/ — Kalorama said that increased incidence of Lyme disease is creating demand not only for testing products, but also for those products to improve. The finding was made in the firm’s most recent study on the market: The Worldwide Market for In Vitro Diagnostics, 11th Edition.
In the US, the incidence of Lyme disease has doubled since 1991, from about four cases per 100,000 people to eight per 100,000 people. It’s likely more, according to CDC information, because Lyme Disease tends to be underreported. Lyme disease treatment – an oral antibiotic against the Borreliaburgdorferi bacterium — is most effective when administered in the early stages of infection. Delayed treatment can lead to long term damage to the nervous system or joints, and many patients fear the disease will become chronic if diagnosed late (although the CDC maintains that most people respond well to treatment even in later stages of the disease).
“Lyme testing represents an area where IVD has made a contribution,” said Bruce Carlson, Publisher of Kalorama Information. “Patients who previously thought they suffered from another disease have been properly identified with the aid of immunoassay testing. Still given the rate of test errors, patients and providers want better tests.”
Yet diagnosing Lyme disease early can be tricky. Many patients do not notice the initial tick bite and early symptoms of Lyme disease may be vague. Only 70 to 80 percent of infected individuals develop a telltale erythema migrans rash. Meanwhile, current tests, which measure Lyme disease indirectly through the antibodies a person’s body creates to fight the disease, tend to perform poorly in the early weeks of an infection because it takes time for antibody production to rise to detectable levels. By some estimates, traditional serology-based test methods identify fewer than 40% of patients with early disease.
For Lyme disease, the most common tick-borne disease in the United States, the CDC has recommended the same testing process since 1995: a serology-based two-tiered algorithm. The first tier is an immunoassay, then if the immunoassay results are positive or equivocal, it is followed by the second tier, a Western blot. To address the issue of false negatives for early-stage infections, the CDC suggests a provider consider treatment based on clinical presentation alone if the patient has had symptoms for less than 30 days, and offer a repeat immunoassay a few weeks later to confirm the diagnosis.
Serology has remained the only technique employed by all of the FDA-approved Lyme disease tests, according to a 2016 review in the Journal of Clinical Microbiology (DOI: 10.1128/JCM.03394-15), even while molecular and “-omics” methods have transformed other realms of clinical microbiology diagnostics.
Enzyme-linked immunosorbent assays (ELISA), which are typically used as the first step in the two-tier algorithm, have improved over the years, with targets that are more specific to Borreliaburgdorferi and less likely to cross react with other infectious agents. Yet their performance is still best when they are paired with Western blots, and Western blot testing has many limitations, including low sensitivity for early stage infections and a labor-intensive, somewhat subjective process.
Kalorama estimates Lyme disease testing at over $100 million, per the company’s recent study on in vitro diagnostics. The report covers microbiology testing, as well as point of care testing and other testing markets.