WASHINGTON, DC – U.S. Senator Jack Reed says progress is being made – but more is needed -- when it comes to diagnosing, treating, preventing, and finding a vaccine for Lyme disease, and other tick-borne illnesses.  Senator Reed has delivered federal investments to help accelerate medical breakthroughs by prioritizing Lyme disease research.  Today, Reed congratulated the ten phase I winners of the LymeX Diagnostics Prize seeking to develop an accurate test that can detect active Lyme infection.

 

Lyme disease is transmitted to humans through infected black-legged ticks, commonly known as deer ticks, which carry bacteria called Borrelia burgdorferi.  Lyme disease is not considered life-threatening, but it can be difficult for doctors to accurately diagnose in patients who don’t develop the classic bullseye rash. Some people without a rash may mistakenly think they have a cold or flu since early symptoms such as fever, chills, and body aches can also be symptoms of Lyme. If quickly and accurately diagnosed, most cases of Lyme disease can be treated successfully with a course of antibiotics.  Left untreated, Lyme disease can spread to joints, the heart, and the nervous system, causing permanent, debilitating neurological damage.

 

LymeX is an ambitious, multimillion-dollar public-private partnership between the U.S. Department of Health and Human Services’ (HHS) Lyme Innovation initiative and the Cohen Foundation that is designed to spur rapid breakthroughs against Lyme disease. 

 

The Lyme Innovation Accelerator competition received submissions from 52 expert teams, hailing from a range of academic institutions, diagnostics corporations, and startup labs.  Entrants submitted a breadth of proposed solutions for detecting active Lyme disease infections in people. Each phase 1 winner received $100,000 and an invitation to participate in a second phase, subject to the availability of future funding.

 

According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 476,000 Americans are diagnosed and treated for Lyme disease each year – including about 1,400 annual Lyme disease cases in Rhode Island, which has one of the highest rates of Lyme disease in the nation.

 

“Lyme disease is a serious and growing health problem.  For too long, it has been a health mystery.  That is why I have boosted federal research dollars and encouraged the federal government to partner with the private sector on a coordinated strategy to help prevent Lyme disease, accelerate research, and strengthen surveillance of tick-borne illnesses,” said Reed.  “I congratulate all the Phase I winners of the LymeX competition.   There is a critical need for accurate Lyme testing and these innovative, promising projects could help close research gaps and lead to major breakthroughs to protect public health.”

 

Reed, a member of the Appropriations Committee, helped deliver a record $91 million federal investment for Lyme disease research in 2021.  Reed has also sought to prioritize federal funding for research and prevention of Lyme and other tick-borne diseases in the appropriations package making its way through Congress.  The new funding would help equip states to more effectively combat the rise in Lyme and other tick-borne diseases.

 

The winners of the Lymex Phase 1 funding include:

 

•           BlueArc Biosciences Inc. Ultra-Sensitive Direct Diagnostic for Early Lyme Disease. A molecular diagnostic blood test for Lyme B. burgdorferi s.l. using innovative polymerase chain reaction (PCR) assay that targets biomarkers for increased accuracy using standard laboratory equipment.

•           Drexel University College of Medicine. Glycoproteomic Approach to Lyme Disease Diagnostics. A small-volume serum test using glycan biomarkers to detect active Lyme disease infection, track treatment response, and distinguish between diseases with similar symptoms.

•           George Mason University. Borrelia Derived, Sequence-Specific Novel Diagnostic Peptides. A urine direct test that targets absolutely specific protein molecules and would provide direct information about pathogen activity.

•           HelixBind Inc. Ultra-Sensitive Direct Detection of Active Borrelia Infections. A test combining novel sample preparation and artificial nucleic acid detection to identify active infection in whole blood, synovial fluid, and cerebrospinal fluid.

•           InBios International Inc. Early Lyme Diagnosis Using a Microarray Immunoassay with Machine Learning. An automated, quantified, array-based serum test using machine learning to improve sensitivity in categorizing specimens.

•           Massachusetts General Hospital. Cell-free Target Capture Sequencing for the Diagnosis of Lyme Disease. A plasma test depleting human background material from samples and detecting low-abundance nucleic acid from tick-borne pathogens.

•           Serimmune Inc. NGS-based Precision Serology for the Diagnosis of Tick-borne Disease. A universal multiplex serum test that incorporates patient-centric surveillance testing, population data, and machine learning to enhance understanding of tick-borne diseases.

           T2 Biosystems Inc. T2Lyme Panel Direct Detection of Active Lyme Disease. A whole blood test designed to directly detect Lyme disease-causing bacteria, providing results in three to five hours with higher accuracy.

•           Tufts University. Antiphospholipid Antibodies for Tracking Lyme Disease After Treatment. A serum test targeting a unique antibody that would more accurately identify early infection and allow clinicians to optimize additional treatment.

•           Virginia Tech. Detecting Release of Peptidoglycan for Direct Lyme Disease Diagnosis. A test using monoclonal antibodies in conjunction with immuno-PCR to detect a unique B. burgdorferi biomarker in multiple biofluids.

 

A 2015 study by the Johns Hopkins University Bloomberg School of Public Health has shown that Lyme disease costs the U.S. health care system up to $1.3 billion in direct U.S. medical costs, and billions more in indirect medical costs.