[Federal Register Volume 86, Number 27 (Thursday, February 11, 2021)]
[Notices]
[Pages 9075-9077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

AGENCY: Office of the Assistant Secretary for Health (OASH), Office of 
the Secretary, Department of Health and Human Services (HHS).

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ACTION: Request for information.

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SUMMARY: The Office of the Assistant Secretary for Health (OASH) in the 
Department of Health and Human Services seeks to obtain information 
regarding the current state of the science and technology to accelerate 
the pace of innovative solutions for the diagnosis of Lyme disease. A 
set of questions is available in the SUPPLEMENTARY INFORMATION section 
below.

DATES: To be considered, comments must be received electronically at 
the email address provided below, no later than 5:00 p.m. Eastern Time 
(ET) March 15, 2021.

ADDRESSES: Individuals are encouraged to submit responses 
electronically to Dr. Kristen Honey, Senior Advisor to the Assistant 
Secretary for Health, 200 Independence Avenue SW, Washington, DC 20201, 
<a href="/cdn-cgi/l/email-protection#e0ac998d85a98e8e8f968194898f8ea0888893ce878f96"><span class="__cf_email__" data-cfemail="98d4e1f5fdd1f6f6f7eef9ecf1f7f6d8f0f0ebb6fff7ee">[email protected]</span></a>, (202) 853-7680. Please indicate ``RFI 
RESPONSE'' in the subject line of your email. Submissions received 
after the deadline will not be reviewed. Responses to this notice are 
not offers and cannot be accepted by the government to form a binding 
contract or issue a grant. Respond concisely and in plain language. You 
may use any structure or layout that presents the information well. You 
may respond to some or all of our questions, and you can suggest other 
factors or relevant questions. You may also include links to online 
material or interactive presentations. Clearly mark any proprietary 
information, and place it in its own section or file. Your response 
will become government property, and we may publish some of its non-
proprietary content.

SUPPLEMENTARY INFORMATION: The HHS Lyme Innovation initiative is a 
patient-centered, data-driven approach to the threat of Lyme disease 
and tick-borne diseases. Lyme disease affects more than 300,000 people 
in the U.S. each year and accounts for more than 70% of all vector-
borne diseases in our country. Lyme and other tick-borne diseases cost 
the U.S. economy billions of dollars annually.
    The HHS Lyme Innovation initiative uses strategic public-private 
partnerships to accelerate advancements in Lyme disease and other tick-
borne diseases. The Lyme Innovation initiative aims to build commitment 
to patient-centered innovations, identify ways to collect and share 
data while raising awareness, accelerate the discovery of next-
generation diagnostic tools and technologies, and lower barriers across 
all phases of development, testing, and implementation. The 
recommendations of the Tick-Borne Disease Working Group to HHS inform 
the Lyme Innovation initiative. The Lyme Innovation initiative 
represents one way that HHS is executing the strategies described in 
``A National Public Health Framework for the Prevention and Control of 
Vector-Borne Diseases in Humans.''
    HHS has entered into a public-private partnership with the Steven 
and Alexandra Cohen Foundation to form the LymeX Innovation Accelerator 
(LymeX). LymeX will accelerate the Lyme Innovation initiative's 
progress and strategically advance tick-borne-disease solutions in 
direct collaboration with Lyme disease patients, patient advocates, and 
diverse stakeholders. A primary goal of the LymeX partnership and the 
Framework is the development of new diagnostic technologies for Lyme 
disease.
    The Centers for Disease Control and Prevention (CDC) website 
(https://www.cdc.gov/lyme/index.html) summarizes information about the 
stages of Lyme disease, current diagnostic testing recommendations, and 
treatment options. CDC currently recommends the use of FDA cleared 
serologic tests in a two-step testing process that detects the presence 
of antibodies to Borrelia burgdorferi, the bacterium responsible for 
Lyme disease.
    Serologic tests for diagnosis of Lyme disease have technical 
limitations. Antibodies may not be produced by the immune system early 
enough or in high enough quantities to meet the detection limit of 
these tests (https://www.hhs.gov/sites/default/files/tbdwg-report-to-congress-2018.pdf). As an antibody response in infected persons 
requires time to develop, serologic tests for Lyme disease may produce 
false negative results during early infection. In areas where Lyme 
disease is highly endemic, the infection may be diagnosed without 
laboratory testing if patients develop a diagnostic skin lesion at the 
site of the tick bite, which is known as erythema migrans (EM) or a 
``bullseye rash.'' However, 20% of patients may not develop this 
specific rash, and sometimes the rash is not seen or recognized. The 
rash also might not display the stereotypical presentation. Therefore, 
these newly infected patients may not be diagnosed in the absence of a 
sensitive diagnostic test and may not receive prompt or proper 
treatment for a disease with the potential to cause disabling illness.
    Serology tests are also not capable of determining if there is an 
active infection. As antibodies normally persist for months or even 
years after the infection is gone, serologic testing cannot be used to 
determine a cure. Additionally, cross-reactions between serologic tests 
for Lyme disease and those for other infectious diseases can also yield 
false positive results.
    These limitations of serological testing compound the scientific 
challenges in identifying specific etiologies for Post-Treatment Lyme 
Disease Syndrome (PTLDS), which is characterized by persistence of 
symptoms for more than 6 months following treatment with oral 
antibiotics. Improvements in Lyme disease diagnostics would enable 
better clinical management of PTLDS patients as well.
    HHS has identified an area of known need in developing more 
advanced diagnostic tests that diagnose infection at all stages of Lyme 
disease. Therefore, the LymeX partnership is embarking on a series of 
initiatives, including prize challenges to develop new diagnostic tests 
for Lyme disease. This RFI is intended to gather information on the 
current state of the science and development landscape for new 
diagnostic tests from the entrepreneurs, scientists, and physicians who 
will develop and use them.
    We encourage responders to answer the following questions:
    <bullet> What challenges/barriers exist for the development and 
validation of innovative diagnostic tests for Lyme disease?
    <bullet> 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])?
    <bullet> What emerging technologies (e.g., epigenetic mapping, 
inflammatory markers, gene arrays, NAAT, or others) might be developed 
or adapted to characterize different stages of Lyme disease, including 
Post-Treatment Lyme Disease Syndrome (PTLDS), etc.?
    <bullet> What analyte (e.g., DNA, RNA, protein, metabolite) does 
existing or developing Lyme disease diagnostic tests detect?
    <bullet> What is the optimal sample type (e.g., whole blood, 
plasma) for the detection of a test analyte in patients with Lyme 
disease? The optimal sample type can be generally defined as the one 
where the analyte can be best detected.
    <bullet> What challenges exist in the implementation and use of 
Lyme disease diagnostic testing in clinical practice?
    <bullet> What role can or should public-private partnerships play 
in accelerating

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development, validation, or appropriate use of innovative Lyme disease 
diagnostic tests, and what factors are most critical to ensure their 
success?
    This information will inform the development of the HHS Lyme 
Innovation initiative and the LymeX public-private partnership to 
create meaningful incentives to develop or validate new diagnostic 
tests for Lyme disease.

Kristen Honey,
Senior Advisor to the Assistant Secretary for Health (ASH), Office of 
the Assistant Secretary for Health, U.S. Department of Health and Human 
Service.
[FR Doc. 2021-02796 Filed 2-10-21; 8:45 am]
BILLING CODE 4150-28-P


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