FDA grants 510(k) approval for ZEUS Borrelia Modified Two-Tiered Testing (MTTT) algorithm to diagnose Lyme disease. Zeus Scientific

ZEUS Scientific, a leading global diagnostic solutions company, announced the launch of its ZEUS Borrelia Modified Two-Tiered Testing (MTTT) algorithm following receipt of FDA 510(k) clearance from the FDA. Approval of the MTTT algorithm represents a true paradigm shift in laboratory testing for Lyme disease.

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 , 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 MTTT algorithm detected up to 30% more acute Lyme disease cases relative to the STTT, significantly reducing the number of missed clinically positive patient samples 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.