Lyme disease is a bacterial contamination that, if untreated, progressively worsens and might debilitate. The longer one waits to deal with Lyme sickness, the tougher it can be to eradicate. Lyme disease signs and symptoms are much like different illnesses and vary among patients, making diagnosis challenging. Most clinicians diagnose Lyme disease via way of means the use of laboratory tests approved by the Food and Drug Administration (FDA) combined with information about a patient’s beyond exposure risk to ticks and signs and symptoms.

FDA-approved diagnostic tests for Lyme disease are “indirect” tests, which means they detect antibodies made by the human body in response to infection. Antibodies can take several weeks to develop, so patients may also check negative if infected recently. Diagnostic testing for lyme disease is yet not helpful. For example, an affected person with the latest tick bite and classic Lyme “bullseye rash” is likely to check negative, despite the fact that they have got Lyme disease because their immune system needs several weeks to develop the antibodies detected by the test. The FDA has yet to approve “direct” diagnostic tests for Lyme disease, which might measure active bacterial infection via way of means of detecting the presence or absence of Lyme-causing microorganisms in the human body.

For patients and clinicians, this current country of Lyme disease testing and diagnosis may be frustrating at best, and horrifically life-altering at worst.
To cope with this need, HHS, via its LymeX Innovation Accelerator (LymeX) in partnership with the Steven & Alexandra Cohen Foundation, issued a Request for Information (RFI) on diagnostic testing for lyme disease.

This LymeX RFI targets to acquire facts on the current state of the technology and development of Lyme disease diagnostic tests. The RFI also seeks to answer how technology developed for COVID-19 diagnostics is probably relevant to Lyme sickness. The LymeX group expects COVID-19 technology and breakthroughs will assist usher in the next technology of Lyme sickness diagnostic tests. Accurate Lyme disease diagnostics are important to advancing the field and LymeX success. As such, it’s one of our 3 LymeX focus areas: (1) stakeholder engagement and patient-focused innovation; (2) Lyme disease education and awareness, and; (3) diagnostics to correctly detect all stages of Lyme disease.