Accelerating Innovation in Diagnostic Testing for Lyme Disease: HHS Request for Information (RFI)

One tick bite can change your life – or the life of your child.

Diagnostics are just one of the many issues surrounding the multifaceted challenges of Lyme disease. Lyme disease is the most common vector-borne disease and fastest-growing vector-borne disease in the United States, accounting for over 80% of all tick-borne diseases domestically. The CDC estimates that approximately 476,000 Americans are diagnosed and treated for Lyme disease each year.

Lyme disease is a bacterial infection that, if untreated, progressively worsens and can debilitate. The longer one waits to treat Lyme disease, the harder it can be to eradicate. Lyme disease symptoms are similar to other illnesses and vary between patients, making diagnosis challenging. Most clinicians diagnose Lyme disease by using laboratory tests approved by the Food and Drug Administration (FDA) combined with information about a patient’s past exposure risk to ticks and symptoms.

Today’s FDA-approved diagnostic tests for Lyme disease are “indirect” tests, meaning they detect antibodies made by the human body in response to infection. Antibodies can take several weeks to develop, so patients may test negative if infected recently. For example, a patient with a recent tick bite and classic Lyme “bullseye rash” is likely to test negative, even though they have 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 would measure active bacterial infection by detecting the presence or absence of Lyme-causing bacteria in the human body. 

For patients and clinicians, this current state of Lyme disease testing and diagnosis can be frustrating at best, and horrifically life-altering at worst.

LymeX: Changing the status quo, together

To address this need, HHS, through its LymeX Innovation Accelerator (LymeX) in partnership with the Steven & Alexandra Cohen Foundation, issued a Request for Information (RFI) on Lyme disease diagnostic tests.

This LymeX RFI aims to gather information on the current state of the science and development of Lyme disease diagnostic tests. The RFI also seeks to answer how technologies developed for COVID-19 diagnostics might be applicable to Lyme disease. The LymeX team expects COVID-19 science and breakthroughs will help usher in the next generation of Lyme disease diagnostic tests.

RFI questions include, but are not limited to:

  • What types of diagnostic technologies are being developed, or could be developed or adapted, to detect Lyme disease, including technologies and breakthroughs adapted from COVID-19 diagnostics with potential applications for Lyme disease (e.g., highly sensitive nucleic acid amplification testing [NAAT])?
  • What challenges exist in the implementation and use of Lyme disease diagnostic testing in clinical practice?
  • What challenges or barriers exist for the development and validation of innovative diagnostic tests for Lyme disease?

Accurate Lyme disease diagnostics are critical to advancing the field and LymeX success. As such, it’s one of our three LymeX focus areas: (1) stakeholder engagement and patient-centered innovation; (2) Lyme disease education and awareness, and; (3) diagnostics to accurately detect all stages of Lyme disease.

The LymeX team invites you to share your expertise related to this LymeX RFI. Your responses will inform the LymeX Diagnostic “Moonshot,” which will be a series of grand-prize challenges launching in 2021. Responses will also augment LymeX market research, which identified the need for improved diagnostic tests for all stages of Lyme disease. HHS will synthesize all LymeX RFI responses and publicly share an anonymized synthesis with the public. Check the HHS LymeX webpage or LymeX.org for updates.

Please submit your RFI responses to LymeInnovation@hhs.gov (subject: RFI RESPONSE) by 5:00 PM ET on March 15th, 2021.

More from: Office of the Assistant Secretary for Health (OASH)

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As shown in figure 2, in response to the directive, agencies reported progress in mitigating risks to more than 11,000 devices as of October 2018. Figure 2: Federal Civilian Agency Vulnerable Network Infrastructure Devices That Had Not Been Mitigated, September 2016 through January 2019 Another key DHS directive is Securing High Value Assets, an initiative to protect the government's most critical information and system assets. According to this directive, DHS is to lead in-depth assessments of federal agencies' most essential identified high value assets. However, an important performance metric for addressing vulnerabilities identified by these assessments does not account for agencies submitting remediation plans in cases where weaknesses cannot be fully addressed within 30 days. Further, DHS only completed about half of the required assessments for the most recent 2 years (61 of 142 for fiscal year 2018, and 73 of 142 required assessments for fiscal year 2019 (see fig. 3)). In addition, DHS does not plan to finalize guidance to agencies and third parties, such as contractors or agency independent assessors, for conducting reviews of additional high value assets that are considered significant, but are not included in DHS's current review, until the end of fiscal year 2020. Given these shortcomings, DHS is now reassessing key aspects of the program. However, it does not have a schedule or plan for completing this reassessment, or to address outstanding issues on completing required assessments, identifying needed resources, and finalizing guidance to agencies and third parties. Figure 3: Department of Homeland Security Assessments of Agency High Value Assets, Fiscal Years (FY) 2018 through 2019 Why GAO Did This Study DHS plays a key role in federal cybersecurity. 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This report addresses (1) DHS's process for developing and overseeing the implementation of binding operational directives and (2) the effectiveness of the directives, including agencies' implementation of the directive requirements. GAO selected for review the five directives that were in effect as of December 2018, and randomly selected for further in-depth review a sample of 12 agencies from the executive branch civilian agencies to which the directives apply. In addition, GAO reviewed DHS policies and processes related to the directives and assessed them against FISMA and Office of Management and Budget requirements; administered a data collection instrument to selected federal agencies; compared the agencies' responses and supporting documentation to the requirements outlined in the five directives; and collected and analyzed DHS's government-wide scanning data on government-wide implementation of the directives. GAO also interviewed DHS and selected agency officials.
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