#United States #Phoenix #Aces Diagnostics #LymeSeek #Protavio

Aces Diagnostics' Vision for Lyme Disease Testing

In a significant step towards revolutionizing the diagnosis of Lyme disease, Aces Diagnostics Inc. has announced pivotal partnerships with Protavio and Repado to further develop its LymeSeek™ test. This innovative diagnostic tool promises to provide clinicians with a highly accurate early detection method for Lyme disease, correctly identifying infection in over 90% of cases at all stages, including the critical early phase when timely treatment is most effective.

The LymeSeek™ Test: Advancements and Impact

The LymeSeek™ test distinguishes itself through its unique design, utilizing a single blood draw combined with a multiplexed immunoassay and a proprietary machine-learning algorithm. Compared to existing standard methods which often struggle to detect early Lyme disease effectively, LymeSeek™ shows remarkable progress, potentially enabling healthcare providers to respond to infections with far greater efficacy than previously possible.

Lyme disease poses a significant public health challenge globally, with estimates suggesting that approximately 14.5% of the world's population is affected. In the United States alone, the Centers for Disease Control and Prevention (CDC) highlights around 476,000 new diagnoses occurring each year, placing Lyme disease among the three most prevalent infectious conditions.

Partnerships for Progress

To facilitate the FDA approval process and compliance with ISO 13485 standards for medical devices, Aces Diagnostics has tapped into the expertise of Protavio, a multiplex proteomics company based in Athens, Greece. Protavio is responsible for constructing the test kit, ensuring the immunoassay's design adheres to rigorous regulatory and quality benchmarks.

In conjunction with Protavio, Repado, an ISO 13485-certified software company with a focus on the life sciences and healthcare sectors, is tasked with developing software for the LymeSeek Analysis. This advanced platform will harness Aces Diagnostics' machine-learning technology, synthesizing data to produce precise, objective diagnostic reports that align with regulatory criteria.

A Commitment to Innovation

Tammy Crawford, CEO of Aces Diagnostics, expressed her enthusiasm: "The development of LymeSeek is a mission-driven effort for our entire team, and these strategic partnerships are instrumental to its success. Protavio's excellence in assay development, coupled with Repado's high-end software engineering for our machine-learning algorithm, ensures we are crafting a substantial, high-quality, and scalable solution for Lyme disease diagnostics."

As Aces Diagnostics, Protavio, and Repado collaborate, they not only pool their expertise in biomarker research, precision manufacturing, and regulatory-compliant medical software but also strive to tackle the pressing issue of delayed Lyme disease diagnosis. Each year, countless patients navigate uncertainty due to inadequate early testing methods, prolonging their suffering and complicating treatment.

Future Outlook

LymeSeek™ is currently advancing through its final development stages, gearing up for clinical validation, regulatory submission, and subsequent review by the FDA. The culmination of extensive research, dedication, and collaboration, LymeSeek™ promises to bridge the diagnostic gap that countless Lyme disease sufferers experience.

In summary, as Aces Diagnostics continues on this path to bring a clinically accurate in-vitro diagnostic tool to the market, it represents hope not only for the millions infected worldwide but also for healthcare providers striving for efficiency and precision in Lyme disease treatment protocols. For further details on their groundbreaking work in Lyme disease testing, visit acesdiagnostics.com.