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NOW PUBLISHED Kalorama’s The Worldwide Market for In Vitro Diagnostic Tests, 11th Edition

European Cuts, Consolidation Drive Vendors to Eastern Europe

Europe is improved slightly from our last report in 2016, on the strength of German, Swiss and Netherlands laboratory spending. Yet the news could be cold comfort. This was once a region that in 2004 contributed 31% of the market; and now
Kalorama estimates Europe is

20%. Not surprisingly, many
companies are seeking out
Eastern Europe as a place to
make larger gains. Their
healthcare systems with some
exceptions are improving.
European diagnostics association
EDMA reports that new
members, (generally Eastern
European nations) spend more three times percentage of their healthcare spend on IVD than do their older members, generally the Western European nations that are seeing testing as a place to trim. There are several promising markets in Eastern Europe. Czech Republic and Poland represent large markets; Bulgaria and Romania are building test infrastructure and growing faster than Eastern Europe average. Kalorama focuses on Romania and Poland in Chapter 3 of our worldwide market study.

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NOW PUBLISHED Kalorama’s The Worldwide Market for In Vitro Diagnostic Tests, 11th Edition

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Glucose Testing Declines and CGM Comes to the Rescue

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Tick-Borne Tests: High Demand Area

for Testing

Tick-borne testing is an area where providers, payors and even consumers are unsatisfied and looking for new innovations. Diagnosing tick-borne diseases can be tricky. Lyme disease, the most prevalent of the tick-borne tests, can be treated more effectively when diagnosis comes early. Yet, 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. By some estimates, traditional serology-based test methods identify fewer than 40% of patients with early disease as it takes time for antibody production to rise to detectable levels.

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.

Some researchers are now advocating for new testing algorithms, in particular a two-ELISA algorithm, where an initial positive or equivocal ELISA result is followed by a second ELISA assay that has slightly different targets. They find this method effective and also 27.1% to 44.0% cheaper than the two-tier algorithm with Western blot. A 2018 study comparing three variations of immunoassay-only algorithms found them all accurate, and in some cases even better than the traditional two-tier algorithm. However, the CDC still recommends the traditional two-tier algorithm.

For the other tick-borne diseases, the diagnostic options are limited. Immunofluorescent assays are available for Babesia, Anaplasma, Ehrlichia and Rickettsia, although accuracy varies by laboratory. Some tick-borne viruses can be detected by specialty labs. For other tick-borne diseases, such as Southern tick-associated rash illness (STARI), there are no immunoassays available. There are no commercially available tests that simultaneously detect multiple tick-borne disease agents.

That explains why the TBD Serochip has gotten so much attention this year and piqued the interest of the public. U.S. National Institutes of Health director Francis Collins even highlighted the February TBD Serochip study in a blog post in June, noting that it was developed by NIH-funded researchers. The TBD Serochip is a serological test, like the commercially available tests today. However, it detects multiple targets based on a variety of newly identified antigenic proteins, so it has the potential to be more specific to Borrelia than other than previous tests. Also, it can detect antibodies to multiple tick-borne pathogens simultaneously. The lead author of the TBD Serochip journal article, Rafal Tokarz, PhD, told Infectious Disease Advisor in March 2018 that the challenge now is to improve the test and make a simpler version that can be used by clinical laboratories.

Some reference laboratories already offer polymerase chain reaction (PCR) blood tests for Lyme disease, but with the caveat that they may be used as an aid to diagnosis but are not diagnostic alone. In general, direct detection of the spirochete bacteria that cause Lyme disease bacteria has not worked clinically because there are so few bacterial cells in the body. As a result, the sensitivity of PCR to B. burgdorferi DNA in blood, plasma, or serum samples from patients with Lyme disease is low.

While academic researchers pursue these new directions, in vitro diagnostics developers appear to be focusing on improving on serology-based tests that are already available, making them faster and easier to use.

For example, Quidel announced in August 2018 that its Sofia 2 Lyme fluorescent immunoassay received FDA 510(k) clearance and a CLIA waiver. The assay, which runs on the 2-pound benchtop Sofia 2 Fluorescent Immunoassay Analyzer, requires only a fingerstick whole blood sample. It detects IgM and IgG antibodies to Borrelia burgdorferi, returning a result in 3 to 15 minutes. With its new CLIA waiver, the assay can now be used in physician offices or clinics.