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Study published in Microbiology Spectrum shows single-step tests outperform conventional two-tier testing in early-stage Lyme disease

MILPITAS, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- IGeneX, Inc., a specialty laboratory focused on tick-borne disease diagnostics today announced study results published in the journal Microbiology Spectrum showing that FDA-cleared innovative single-step immunoblot (IB) IGeneX tests significantly improve the detection of Lyme disease, particularly during its earliest stages, when diagnosis is most challenging and timely treatment is critical. The peer-reviewed manuscript titled Single Step Immunoblot Tests with Recombinant Protein Antigens for Detecting IgG and IgM Antibodies in Lyme Disease showed the IB tests detected antibodies in 58.3% of cases compared to 30.0% with commonly used standard two-tier testing (STTT), nearly doubling accurate detection of Lyme disease during the critical early window.

Developed by researchers at ID-FISH Technology and IGeneX, the IgG and IgM IB antibody tests incorporate recombinant protein antigens derived from multiple Borrelia species and strains found in both the United States and Europe. This broader antigenic coverage enhances antibody detection compared to conventional STTT, which typically relies on a single Borrelia burgdorferi strain. In addition, the single-step format simplifies laboratory workflows and reduces turnaround time by eliminating the need for sequential testing.

“These findings represent a meaningful advancement in Lyme disease diagnostics, particularly given that commonly used FDA-cleared MTTT and STTT testing methods have been shown to miss 64–78% of early Lyme disease cases,” said Jyotsna S. Shah, PhD, lead author and President of IGeneX. “Our FDA-cleared single-step immunoblot demonstrated improved early detection while simplifying the testing process, with the potential to significantly enhance patient care through earlier and more accurate diagnosis, more timely treatment, and ultimately better patient outcomes.”

A More Sensitive Approach—Especially in Early Disease
Lyme disease diagnosis has traditionally relied on STTT, which involves an initial enzyme immunoassay followed by a confirmatory Western blot. While effective in later stages of infection, this approach has reduced sensitivity in early disease, when antibody levels are still developing. The newly developed single-step IB tests are designed to address this limitation by improving early detection while streamlining the testing process.

The study evaluated more than 1,100 serum samples, including well-characterized panels from the U.S. Centers for Disease Control and Prevention (CDC) and the Bay Area Lyme Foundation’s Lyme Disease Biobank (LDB). Key findings include:

• Among CDC stage 1 (early) Lyme disease samples, the IgG IB test detected antibodies in 58.3% of cases, compared to 30.0% with STTT.

• In 290 acute-phase LDB samples, the IgG IB test significantly outperformed STTT.

• When IgG and IgM IB tests were used together, antibodies were detected in 30.2% of patients with confirmed erythema migrans (EM) lesions, compared to 20.6% with STTT. Discrepancy analysis confirmed that 21 of 22 samples positive by IB but negative by STTT were true positives.

These improvements are particularly important in early-stage Lyme disease, when antibody levels are low and false-negative results are more common as shown in a recent study by Bay Area Lyme Foundation’s Lyme Biobank. Enhanced early detection can support diagnosis during the critical window when timely intervention can improve patient outcomes.

“There is an urgent need for more accurate diagnostic tests for Lyme patients, particularly in early-stage disease when standard testing falls short. The well-characterized samples from Bay Area Lyme Foundation’s Lyme Disease Biobank included in this study enabled researchers to rigorously evaluate performance of the new IGeneX single-step immunoblot tests,” said Liz Horn, PhD, MBI, Principal Investigator of the Lyme Disease Biobank and co-author on the study. “This study demonstrates how a more sensitive, streamlined approach can improve detection and highlights the potential of this technology to support earlier and more accurate diagnosis for Lyme patients.”

High Specificity Across Diverse Conditions
The IB tests also demonstrated excellent specificity across a wide range of control samples. Among 387 sera from individuals with potentially cross-reactive conditions—including other tick-borne diseases, autoimmune disorders, viral infections, and pregnancy—only one IgM false positive was observed. This corresponds to a specificity of approximately 99.7% for IgM and 99.4–100% for IgG.

Notably, no cross-reactivity was observed in the IgG IB test, further supporting its clinical reliability.

Scientific Innovation Driving Performance
The improved performance of the IB tests is driven by several key innovations, including a proprietary Lyme Screen Antigen (LSA) derived from immunodominant regions of the VlsE protein across multiple Borrelia species, along with additional antigens such as OspA (P31) and OspB (P34).

This expanded antigen panel enhances detection of diverse immune responses and reflects the genetic variability of Lyme disease-causing organisms.

Foundation for FDA-Cleared Diagnostics
The IB tests described in the study form the scientific foundation for the iDart^™ IgG and IgM Immunoblot Tests, which have received 510(k) clearance from the U.S. Food and Drug Administration for the laboratory diagnosis of Lyme disease.

About the Study
The study analyzed more than 1,100 serum samples from CDC and LDB panels. All testing was conducted in a blinded manner, with independent statistical validation and discrepancy resolution using clinical and serological criteria.

About IGeneX and ID-FISH Technology
IGeneX, Inc. is a CLIA-certified, CAP-accredited specialty laboratory based in Milpitas, California, focused on tick-borne disease diagnostics. ID-FISH Technology, Inc. is its research and development affiliate dedicated to advancing innovative infectious disease testing solutions.

About Bay Area Lyme Foundation
Bay Area Lyme Foundation, a national organization committed to making Lyme disease easy to diagnose and simple to cure, is the leading public charity sponsor of innovative Lyme disease research in the U.S. A 501c3 organization based in Silicon Valley, Bay Area Lyme Foundation collaborates with world-class scientists and institutions to accelerate medical breakthroughs for Lyme disease. It is also dedicated to providing reliable, fact-based information so that prevention and the importance of early treatment are common knowledge. Historically, a pivotal donation from the LaureL STEM fund covered all overhead costs through 2024. In 2023, a Bay Area Lyme Endowment was formed, which allows for 100% of all donor contributions to Bay Area Lyme Foundation to go directly to research and prevention programs in perpetuity. For more information about Lyme disease or to get involved, visit www.bayarealyme.org or call us at 650-530-2439.

About Lyme Disease Biobank
Lyme Disease Biobank (LDB), a program of Bay Area Lyme Foundation, is a non-profit organization working to accelerate research of Lyme disease and other tick-borne infections. With a collection of biological specimens from more than 1,250 participants, including blood, serum, plasma, urine and tissue, LDB provides much-needed samples to approved researchers working to better understand tick-borne diseases and develop improved diagnostic tests and therapeutics. Blood and urine samples are collected from the Northeast, Upper Midwest and West Coast areas of the U.S., and tissue samples are collected throughout the country. Researchers interested in obtaining samples should visit www.lymebiobank.org or contact info@lymebiobank.org.

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