ImmuneSense Lyme Study

Lyme season is here.

Your patients may hold the key to a new and potentially better diagnostic test.

About 300,000 people in the U.S. are infected with Lyme disease through tick bites each year. 1,2

The Northeast, the Mid-Atlantic region and the Upper Midwest are hotspots.

Only 30% of people with acute Lyme infections receive a positive test result with existing laboratory tests. 3

The ImmuneSense™ Lyme study is currently collecting blood samples from patients for clinical validation of a T-cell-based assay that is a potential diagnostic for Lyme disease.

The T-cell-based test may offer:

• Earlier detection of Lyme disease than current tests

• A look at patients’ T-cell immune response to the bacteria that causes Lyme disease

Your patients can contribute to validating this novel test, and may be eligible to earn as much as $400 for taking part in the study.

Your patients can enroll in ImmuneSense Lyme study by filling out this questionnaire.

Participation is easy

You identify a patient that you suspect has early acute Lyme disease.

You direct your patient to to enroll in the study by visiting ImmuneSenseStudy.com.

Your patient fills out a screening questionnaire. If they qualify, they will get periodic blood draws (~100 mL) and earn $100 for each visit (up to four) for participating.*

* Participants have the option of completing study activities at a local clinical site or through a free mobile phlebotomy service and no-contact telehealth appointments.

Lyme disease: A diagnostic puzzle

Medical guidelines for Lyme disease diagnosis recommend performing two sequential serological tests. The sensitivity of this approach is poor in early stages of the disease, as two-step testing only successfully diagnoses between 17 and 40% of acute Lyme disease cases presenting with an EM rash. 4

Lyme disease is easy to miss:

• Up to 30% of infected people never get an EM rash at the site of the tick bite.

• The rash doesn’t always have the classic bullseye appearance— it can vary in color and shape.

• A rash can appear three to 30 days after the tick bite, and may not itch.

• A rash can be easy to miss due to its location, such as behind the knee, in the underarm or behind the ear.

• Symptoms of Lyme disease can mirror those of many other conditions.

Be on the lookout for Lyme disease symptoms, which may include:

  • Erythema migrans (EM) rash
  • Fever
  • Chills
  • Headache
  • Fatigue
  • Swollen lymph nodes
  • Neuropathy
  • Intermittent arthritis
  • Meningitis
  • Heart block
  • Carditis

Leaving Lyme disease untreated can lead to devastating long-term health consequences, from chronic joint inflammation and facial palsy to memory loss and heart rhythm irregularities. 5

Examples of erythema migrans rashes

Lyme disease season is here.
Now is the time to act.

Build awareness

Post the accompanying flyer in your office where your patients can see it.

Inform your patients

If you suspect Lyme disease in a patient, direct them to ImmuneSenseStudy.com, where they can find out if they qualify for the study.

Continue standard of care

Your patient’s participation in the study need not change the standard of care you provide.

Study parameters

  • Ages 18 and up
  • Symptoms suggestive of Lyme disease, with an EM rash
  • If on antibiotics, initiated less than 1 week ago
  • Up to four blood draws to be taken over 12 months

Get involved.

Enter your information to learn more about contributing to the ImmuneSense™ Lyme study.

More about the ImmuneSense TM Lyme study

The ImmuneSense™ Lyme study is investigating T-Detect™ Lyme, an assay for diagnosing Lyme disease. T-Detect™ Lyme uses multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) to assess rearranged T cell–receptor beta (TRB) gene sequences from genomic DNA isolated from peripheral blood.

T-Detect™ is under development for multiple diseases translating the natural diagnostic capability of T-Cells into clinical practice. In 2018, Adaptive and Microsoft collaborated to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T cell–receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders, and cancer. From a simple blood draw, T-Detect™ will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect™ COVID is the first clinical test launched from this collaboration and the first commercially available T cell test designed to detect recent or prior SARS-CoV-2 infections. T-Detect™ COVID is an EUA-authorized test that is available for prescription use only.

The ImmuneSense™ Lyme study is sponsored by Adaptive Biotechnologies, a leading commercial-stage biotechnology company.

Adaptive offers physicians unique opportunities to be involved in this study. Please fill out the form to be contacted.

Adaptive Biotechnologies

Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision, and speed to develop products in life sciences research, clinical diagnostics, and drug discovery. We have three commercial products and a robust clinical pipeline to diagnose, monitor, and enable the treatment of diseases such as cancer, autoimmune conditions, and infectious diseases. Our goal is to develop and commercialize immunedriven clinical products tailored to each individual patient.

For more information, please visit adaptivebiotech.com.

References

1Adams DA, Jajosky RA, Ajani U, et al. Summary of notifiable diseases–United States, 2012. MMWR Morbidity and mortality weekly report. 2014;61(53):1-121.

2Nelson CA, Saha S, Kugeler KJ, Delorey MJ, Shankar MB, Hinckley AF, Mead PS. 2015. Emerg Infect Dis. 2015 Sep;21(9):1625-31. Incidence of Clinician-Diagnosed Lyme Disease, United States, 2005-2010.

3Branda, J. A., et al. Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease. Clinical Infectious Diseases. 2017;64(8):1074-1080. doi: 10.1093/cid/cix043

4Nadelman RB, Nowakowski J, Forseter G, Goldberg NS, Bittker S, Cooper D, Aguero-Rosenfeld M, Wormser GP. 1996. Am J Med. 1996 May;100(5):502-8. The clinical spectrum of early Lyme borreliosis in participants with culture-confirmed erythema migrans.

5Nowakowski J, Schwartz I, Liveris D, Wang G, Aguero-Rosenfeld ME, Girao G, McKenna D, Nadelman RB, Cavaliere LF, Wormser GP; Lyme Disease Study Group. 2001. Clin Infect Dis. Dec 15;33(12):2023-7. Laboratory diagnostic techniques for participants with early Lyme disease associated with erythema migrans: a comparison of different techniques.

6Schriefer ME. 2015. Clin Lab Med. Dec;35(4):797-814. Lyme Disease Diagnosis: Serology.

7Steere AC, McHugh G, Damle N, Sikand VK. 2008. Clin Infect Dis. Jul 15;47(2):188-95. Prospective study of serologic tests for lyme disease.

8Zweitzig D, Kopnitsky M. Validation of a Modified Two-Tiered Testing (MTTT) Algorithm for the Improved Diagnosis of Lyme Disease (white paper).

9Brand JA, Strle K, Streere AC. Clin Infect Dis 2017 Apr 15;64(8):1074-1080 Evaluation of Modified 2-Tiered Serodiagnostic Testing Algorithms for Early Lyme Disease.

For investigational use only. Not for diagnostic use.

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