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PHILADELPHIA, May 3, 2017 /PRNewswire/ — Advanced Laboratory Services, Inc. (ALSI), a leading diagnostic laboratory focused on specialty assays, announced that is has reached over 50% enrollment for its Borrelia Diagnostic Test (BDT) clinical trial. This prospective, multicenter, two-cohort study is the company's pivotal clinical trial to gain FDA clearance to commercialize the BDT in the United States, and will enroll approximately 300 patients at 13 targeted sites in areas with a high prevalence of Lyme disease.
According to the CDC, roughly 30,000 new cases of Lyme disease are reported in the U.S. each year; however, due to misdiagnosis and missed diagnoses, the actual number of new cases per year is estimated to be as many as 300,000. The medical need to accurately detect Borrelia spirochetes, the bacterium that causes Lyme disease, is critical to help clinicians better prevent the debilitating effects of the later stages of this infection and to reduce associated healthcare costs. Although serological testing for Lyme disease is widely used, these only test for immunologic response to the pathogen, and therefore are indirect assays. They have performed poorly due to species and strain diversity of Borrelia, as well as both technical and host factors. In contrast, the ALSI BDT provides direct testing of human serum for the presence of Borrelia spirochetes. The culture technology of the BDT has been available from ALSI since 2011 and is indicated for symptomatic Lyme disease patients.
This is a landmark study, as no two-cohort study of early and late Lyme disease subjects has been launched to date for a direct Borrelia diagnostic culture. The ongoing multicenter study is intended to demonstrate specificity and sensitivity that is superior to currently marketed conventional microbiological methods. According to the sponsor's laboratory director, Dr. Timothy Schwartz, "the primary objective of the study is to determine the accuracy of the ALSI Borrelia Diagnostic Test (BDT) as compared to conventional microbiological methods, with a secondary objective to compare the accuracy of the ALSI culture for evaluating early-onset and late-onset presentations of Lyme disease."
Conducted domestically, the study is planned to have a 14-month enrollment period. The primary endpoint data for diagnostic test predictive values is expected to be available in late 2017. More information about the trial is available at www.clinicaltrials.gov (NCT02741609).
The Advanced Laboratory Services Borrelia Diagnostic Test (ALSI BDT) is a culture and immunostaining procedure for the detection of Borrelia spirochetes in venous whole blood samples. The ALSI BDT should only be used for patients with signs and symptoms that are consistent with Lyme disease. Positive results are supportive evidence of infection with Borrelia and can be used to support a clinical diagnosis of Lyme disease. The main objective of this confirmatory multicenter clinical trial is to demonstrate that the Borrelia culture as developed by ALSI provides highly sensitive and specific results to supplement or replace current diagnostic methods for Lyme disease.
About ALSI, Inc.
Advanced Laboratory Services, Inc. is a state-of-the-art medical laboratory testing company that is committed to developing and releasing new cutting-edge testing methods to aid clinical diagnosis and treatment. Their comprehensive laboratory testing facility was established to fulfill the needs of physicians, clinics, and their patients, and provide private and confidential testing throughout the United States. ALSI is CLIA certified, HIPAA compliant, and has earned The Joint Commission's Gold Seal of Approval.
For additional information about ALSI, visit their website, www.advanced-lab.com.
Statements made in this press release that look forward in time or that express management's beliefs, expectations, or hopes are forward-looking statements. Such forward-looking statements reflect the views of management at the time such statements are made and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations.
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Source: By Advanced Laboratory Services, Inc. May 3, 2017. Advanced Laboratory Services, Inc. Achieves 50% Enrollment in the Borrelia Diagnostic Test Clinical Trial for Lyme Disease. PRNewswire.com.