WEBINAR:
FDA Cleared Lyme Disease Tests
FDA Cleared Lyme Disease Tests
What This Means for Laboratories, Doctors, and Patients.
OVERVIEW OF THE WEBINAR
IGeneX is thrilled to announce that our Lyme ImmunoBlots have been converted to FDA cleared test kits. The IgG kit received FDA clearance in August 2024, and the IgM kit in June 2025. Having both IgM and IgG kits allows for full diagnostic coverage of the disease. The kits are manufactured by ID-FISH Technology, Inc. and are called iDart™ Lyme IgM ImmunoBlot Kit and iDart™ Lyme IgG ImmunoBlot Kit. The kits will be available to laboratories in late 2025. However, the ImmunoBlot Laboratory Developed Test (LDT) from IGeneX is available now to doctors and patients and continues to be our most prescribed test due to its superior sensitivity and specificity.
You will learn
- What FDA clearance means
- How Lyme test results interpretation is now based upon new criteria and not CDC criteria
- Details of the IGeneX ImmunoBlot Lyme disease test, including sensitivity, specificity, and more
- How to use a patient’s clinical presentation to determine which test to choose
SPEAKER
Dr. Joseph J. Burrascano Jr.
IGeneX Consultant
Dr. Burrascano is an IGeneX Consultant and well-recognized specialist in the diagnosis and treatment of Lyme disease and associated complex infectious diseases, and the chronic illnesses that accompany them. With over 35 years of research in this field, he has appeared in and on virtually every form of media, both in the US and abroad. He has testified before the US Senate and armed services joint subcommittee and at various governors’ consulates. He is also a founding member of ILADS and ILADS Educational Foundation.
WATCH VIDEO AND DOWNLOAD SLIDES
Who is the webinar for?
This webinar is perfect for those who would like to get a basic understanding of the various Lyme disease test options. It is also useful for laboratories who would like to replace their current Lyme disease testing with an FDA cleared test.
Outline
- What FDA clearance means
- Advantages of the IGeneX ImmunoBlots
- Most effective Lyme test
- Testing for co-infections, including Babesia, Bartonella, and TBRF
Download the slides from the webinar here.
Get in Touch
If you are a physician and would like to learn more about IGeneX or our tick-borne disease testing products, let us know by completing the form below or calling us at 1-800-832-3200. If you are a patient, please do not use this form. Send an email to customerservice@igenex.com or call us at 1-800-832-3200.
Ask Anything Town Hall
Town Hall style session for doctors to connect with leaders at IGeneX to ask questions on testing, tick-borne diseases, or anything else that will help them in their practice.
Session #1
Click to jump to a question:
- Are there any organisms that can give a false positive Babesia test?
- What is the best way to confirm that a patient has been adequately treated for Lyme? IgXSpot? FISH?
- What are the best use cases for Bartonella IFA and Western Blots tests?
- How do you interpret indeterminate results for Relapsing Fever ImmunoBlot?
- Does Relapsing Fever Borrelia respond differently in treatment than other Borrelia species?
- What are your thoughts on treatment when a patient presents with TBRF?
- How much more sensitive is the ImmunoBlot versus the PCR urine test?
- For Morgellon’s patients, what is the best test to determine if they have Lyme disease or TBRF?
- Is a Urine PCR Panel good to use on Morgellons patients?
- Should you prime the immune system with antibiotics before testing?
- What testing is best for Myocarditis?
Session #2
Click to jump to a question:
- What panels do you use for Morgellons?
- How do you diagnose Alpha-Gal?
- Can a patient with Multiple Sclerosis trigger a false positive Lyme antibody test?
- Did my patient trigger a false positive Bartonella test?
- Is Bartonella the cause of my patient’s joint pain?
- If my patient is negative for Lyme, should I reflex to a Relapsing Fever test?