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Classified in: Science and technology
Subject: FDA

ZEUS Scientific Announces U.S. FDA 510(k) Clearance of its ZEUS Borrelia Modified Two-Tiered Testingtm Algorithm, a Paradigm Shift in Laboratory Testing for Lyme Disease

BRANCHBURG, N.J., July 30, 2019 /PRNewswire-PRWeb/ -- ZEUS Scientific, a leading global diagnostic solutions company, today announced the launch of its ZEUS Borrelia Modified Two-Tiered Testingtm (MTTT) algorithm following receipt of FDA 510(k) clearance from the U.S. Food and Drug Administration. Approval of the MTTT algorithm represents a true paradigm shift in laboratory testing for Lyme disease.

Lyme disease, caused by the bacterium Borrelia burgdorferi, is the most common vector-borne disease in the United States and is transmitted to humans through the bite of infected blacklegged ticks. Cases of Lyme disease have almost tripled since the 1990s to more than 300,000 annually(2) and have been found in all 50 states(3). The number of cases in Europe is also on the rise(4).

Serological evidence of exposure is an important aid in the diagnosis of Lyme disease. The Standard Two-Tiered Testing (STTT) algorithm for the serodiagnosis of Lyme disease was devised by attendees of the Second National Conference on Serologic Diagnosis of Lyme Disease (Dearborn, MI) in 1994(5). For 25 years, there have been no significant changes to this algorithm even though several issues with the current STTT algorithm exist, including low sensitivity in the early stages of disease(6) and false positive results associated with IgM immunoblots(7).

Chris Howard, Chief Commercial Officer at ZEUS Scientific remarked, "With nearly 30% of early Lyme disease cases being potentially missed by the current STTT algorithm due to the insensitivity of immunoblot tests(8), we are ecstatic to have successfully improved one of the most challenging aspects of diagnosis: detecting the disease early, before a robust immune response has been developed by some patients." Howard continued, "Our ZEUS Borrelia MTTTtm algorithm detected up to 30% more acute Lyme disease cases relative to the STTT, significantly reducing the number of missed clinically positive patient samples(1) while maximizing lab efficiency with fully automatable immunoassays."

The STTT algorithm uses a first-tier immunoassay with equivocal or positive specimens subsequently tested by an immunoblot. Clinical laboratories have been burdened by the complexities and subjectivity of immunoblot testing for years, often needing to send these tests out to reference labs, leading to longer turnaround time for test results, increased resource allocation and higher costs.

ZEUS Borrelia MTTTtm uses the ZEUS ELISAtm Borrelia VlsE1/pepC10 IgG/IgM Test System as a first-tier test with positive or equivocal specimens subsequently tested using a second ZEUS ELISAtm Test System. With this convenient, all-ELISA MTTT algorithm in which two different options have been FDA-cleared, laboratories can now easily and efficiently run first-tier and second-tier testing in-house, benefiting from:

"We envisioned a similar MTTT concept more than ten years ago, but were unable to convince regulators of this powerful concept at that time(10). Since then, many other accomplished researchers have repeatedly demonstrated that the MTTT algorithm is clinically more sensitive, yet equally as specific as the STTT algorithm." stated Mark Kopnitsky, Chief Scientific Officer of ZEUS Scientific. "We are thrilled that we can finally offer this MTTT algorithm to the clinical laboratories and hope to improve their ability to detect cases of early Lyme disease."

Thirty years ago, ZEUS pioneered the serodiagnosis of Lyme disease with the very first FDA-cleared screening test, and ZEUS continues to pioneer advances in the serodiagnosis of Lyme disease with the first FDA clearance of this MTTT algorithm. As a leader in infectious disease testing, ZEUS Scientific continues to develop the highest quality testing and improved methods to support better patient outcomes.

"The prevalence of Lyme disease is growing and is difficult to diagnose early, at a time when patients need it most," stated Scott Tourville, Chief Executive Officer of ZEUS Scientific. "This testing paradigm shift is a successful response to longstanding clinical and workflow challenges in the laboratory. I am extremely proud of our research and clinical trial teams in making the promise of MTTT a reality. Labs gain fast, accurate results through an efficient protocol, doctors gain higher confidence in diagnostic assessment, and patients achieve better care with appropriate diagnosis."

Learn more about ZEUS Borrelia MTTTtm and complete line of FDA-cleared tests for Lyme disease at zeuslyme.com. For information on the company's extensive line of infectious and autoimmune disease tests, visit http://www.zeusscientific.com or e-mail sales(at)zeusscientific(dot)com. To speak with a ZEUS Scientific Account Manager, call 1-800-286-2111 or (908) 526-3744.
About ZEUS Scientific
ZEUS Scientific is your first choice for high-performing, easy-to-use clinical diagnostic solutions. Our products are designed and manufactured to ensure optimal efficiency and accurate diagnosis to facilitate better patient care. ZEUS Scientific is based in Branchburg, New Jersey and markets test systems around the world through a direct sales team in the U.S. and Canada and an extensive international distribution network. ZEUS complies with the international standard ISO 13485 (2016), Health Canada Medical Device Regulations (SOR/98-282, May 7 1998), the FDA Quality System Regulations (FDA Quality System Regulation, 1996: 21 CFR § 820), and the IVD 98/79/EEC.

For more information visit: http://www.zeusscientific.com or call +1 (800) 286 2111.

1 Data on file, ZEUS Scientific
2 https://www.cdc.gov/lyme/stats/humancases.html
3 https://questdiagnostics.com/dms/Documents/health-trends/Quest_LymeDiseaseTrendsReport_2018.pdf
4 https://ecdc.europa.eu/sites/portal/files/media/en/healthtopics/vectors/world-health-day-2014/Documents/factsheet-lyme-borreliosis.pdf
5 https://www.ncbi.nlm.nih.gov/nlmcatalog/9807545
6 Branda JA, Body BA, Boyle J, Branson BM, Dattwyler RJ, Fikrig E, Gerald NJ, Gomes-Solecki M, Kintrup M, Ledizet M, Levin AE, Lewinski M, Liotta LA, Marques A, Mead PS, Mongodin EF, Pillai S, Rao P, Robinson WH, Roth KM, Schriefer ME, Slezak T, Snyder J, Steere AC, Witkowski J, Wong SJ, Schutzer SE. Advances in Serodiagnostic Testing for Lyme Disease Are at Hand. Clin Infect Dis 2018 Mar 19;66 7:1133-1139.
7 Seriburi V, Ndukwe N, Chang Z, Cox ME, Wormser GP. 2012. High frequency of false positive IgM immunoblots for Borrelia burgdorferi in clinical practice. Clin Microbiol Infect 18:1236-1240
8 Moore A, Nelson C, Molins C, Mead P, Schriefer M. Current guidelines, common clinical pitfalls, and future directions for laboratory diagnosis of Lyme disease, United States. Emerg Infect Dis. 2016 Jul. http://dx.doi.org/10.3201/eid2207.151694
9 Bacon R., et al. 2003. Serodiagnosis of Lyme Disease by Kinetic Enzyme-Linked Immunosorbent Assay Using Recombinant VlsE1 or Peptide Antigens of Borrelia burgdorferi Compared with 2-Tiered Testing Using Whole-Cell Lysate. J Infect Dis. 187:1187-1199
10 Porwancher R., et al. 2011. Multiplex Immunoassay for Lyme Disease Using VlsE1-IgG and pepC10-IgM Antibodies: Improving Test Performance Through Bioinformatics. Clin Vaccine Immunol. 18(5):851-859.


SOURCE ZEUS Scientific

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