IGeneX Inc. offers accurate, reliable, comprehensive, and rapid testing for tick-borne illnesses, relapsing fever, and Lyme disease, and leads in research and testing development for Lyme disease and tick-borne illnesses assessment globally.
Located in Milpitas, California, IGeneX was initiated in 1991 by the leading pioneer in Lyme disease. They focus on research and development to improve diagnostic testing methods and to increase specificity and capabilities to detect more tick-borne pathogens.
IGeneX Inc. is committed to educating patients and practitioners and facilitating collaboration with clinical practitioners to improve access to diagnosis and management of Lyme and tick-borne illnesses.
In addition to Lyme disease testing, IGeneX also tests for a broad array of tick-borne pathogens and co-infections that could be mistaken for or complicate a Lyme disease diagnosis.
IGeneX Inc. was founded in 1991 by Dr. Nick Harris, a pioneer in Lyme disease, after acquiring the Diagnostics Division from 3M. Starting with just a dedicated team of seven, Dr. Harris focused on developing more sensitive diagnostic tests for Lyme disease due to the limitations of existing methods.
His innovations significantly advanced the diagnosis of Lyme and other tick-borne diseases, and he played a key role in establishing the International Lyme and Associated Diseases Society (ILADS), which trains physicians and promotes Lyme literacy.
In 1997, Dr. Jyotsna Shah joined IGeneX, bringing over 40 years of research experience in infectious disease diagnostics and holding more than 20 patents.
Recognizing that the standard testing criteria were too restrictive, Dr. Shah worked to overhaul these standards, collaborating with top researchers and clinicians to develop new in-house testing criteria that expanded the range of detectable proteins and adapted to the global diversity of Lyme disease infections.
This led to more effective and accurate diagnostics, greatly enhancing the lab's ability to identify true positives without sacrificing specificity.
IGeneX Inc. prioritizes research and development to create highly accurate diagnostic tests for Lyme disease, Tick-Borne Relapsing Fever, and other related illnesses. Notably, IGeneX was the first to identify Borrelia burgdorferi in California ticks and Babesia in New York, Switzerland, and Australia using its patented FISH technology.
Notably, the ImmunoBlot test for Lyme disease has a sensitivity greater than 93%, whereas the ELISA and Western Blot two-tier testing protocol recommended by the CDC has a sensitivity of only 57.6%.
Its proprietary testing criteria, developed through extensive research and validation studies, are more sophisticated than the conventional criteria established in 1994, allowing for greater diagnosis and understanding of these diseases.
Transition to Immunoblot Technology
IGeneX will be discontinuing its Lyme disease Western blot by the end of 2023 after more than 25 years of use, due to significant advancements in their ImmunoBlot technology.
Introduced in the late 1970s, the Western blot method was initially a breakthrough for detecting antibodies to tick-borne diseases. However, over the past five decades, technologies have evolved beyond the capabilities of the Western blot.
The IGeneX ImmunoBlot, a major advancement over the Western blot, has two key benefits: it can detect multiple pathogens simultaneously, and it utilizes specifically engineered recombinant proteins for greater specificity.
In addition to their dedication to research and development, IGeneX is committed to education and collaboration within the medical community.
Recognizing the importance of empowering patients and practitioners with knowledge about Lyme disease and tick-borne illnesses, IGeneX actively engages in educational initiatives aimed at raising awareness and facilitating informed decision-making regarding diagnosis and management.
IGeneX is also deeply involved in the Lyme community, collaborating with specialist groups and foundations to enhance physician education and promote awareness.
Through their commitment to research and development, IGeneX prioritizes innovative testing techniques as well as compliance with the standards and training procedures necessary to ensure accurate test results and protect the health and safety of human test clients.
IGeneX is CLIA-certified and holds state licenses in states where separate licensure is required.
Lyme disease is a complex illness caused by the bacterium Borrelia burgdorferi and transmitted through the bite of infected ticks. To accurately diagnose Lyme disease and its potential co-infections, IGeneX offers a comprehensive range of tests utilizing state-of-the-art technologies.
The following tests are not available for patients over 65 when ordered through physician services.
The Lyme ImmunoBlot is a qualitative assay designed to detect antibodies to B. burgdorferi strains and species. It includes both IgG and IgM antibodies, with IgM antibodies potentially present as early as one week after a tick bite and typically remaining positive for six to eight weeks after initial exposure.
IgG antibodies, on the other hand, are usually detectable a few months following the initial infection.
The IgG/IgM Antibody Serology test looks for both IgG and IgM antibodies to B. burgdorferi. IgM antibodies are detectable shortly after infection, while IgG antibodies often persist long after symptoms have resolved.
It is recommended to confirm a positive or equivocal result with both IgG and IgM ImmunoBlots.
This test is ideally conducted at least four weeks after exposure.
The Lyme ImmunoBlot Panel 1 is specifically designed to detect Lyme disease. It combines three tests: Lyme IgG/IgM/IgA Screen, Lyme ImmunoBlot IgM, and Lyme ImmunoBlot IgG.
The IGXSpot test is an enzyme-linked immunospot assay used to detect human T cells reactive to Borrelia/pathogen-specific antigens in vitro. It's particularly recommended for detecting very early and/or late Borrelia/pathogen infections, especially in seronegative patients' whole blood samples.
When combined with Lyme ImmunoBlot tests, it provides valuable insights into a patient's immune response to infection and disease stage.
The Lyme ImmunoBlot Panel 2 is tailored to detect Lyme Disease, combining four tests: Lyme ImmunoBlot IgM & IgG, Lyme Multiplex PCR – Whole Blood, and Lyme Multiplex PCR – Serum.
The Lyme PCR Panel 1 is specifically designed to detect Lyme disease through serum and whole blood Lyme Multiplex PCR tests. This approach provides a direct means of detecting Borrelia burgdorferi-specific DNA sequences.
The Tick Borne Disease Panel 5IB is designed to detect multiple tickborne diseases. It combines 14 tests to detect Lyme Disease, TBRF, Bartonellosis, Babesiosis, Rickettsiosis, Anaplasmosis, and Ehrlichiosis.
Individual Tests: Lyme Disease
Lyme ImmunoBlot IgM Speciation
Lyme ImmunoBlot IgG Speciation
Lyme Broad Coverage Antibody Panel
Lyme Multiplex PCR Whole Blood
Lyme Multiplex PCR Urine (pooled)
Individual Tests: Tick-Borne Relapsing Fever (TBRF)
TBRF ImmunoBlot IgM Speciation
TBRF ImmunoBlot IgG Speciation
Broad Coverage TBRF Borrelia Ab Assay
Individual Tests: Babesiosis
Individual Tests: Bartonellosis
Bartonella ImmunoBlot IgG + IgM
Individual Tests: Ehrlichiosis
HME (Ehrlichia chaffeensis) IgM & IgG IFA
HME (Ehrlichia chaffeensis) PCR Serum
HME (Ehrlichia chaffeensis) PCR Whole Blood
HME (Ehrlichia chaffeensis) PCR Urine
Ehrlichia cePCR (Culture enhanced)
Individual Tests: Anaplasmosis
HGA (Anaplasma phagocytophilum) IgM & IgG IFA
HGA (Anaplasma phagocytophilum) PCR Serum
HGA (Anaplasma phagocytophilum) PCR Whole Blood
HGA (Anaplasma phagocytophilum) PCR Urine
Individual Tests: Rickettsiosis
R. rickettsii & R. typhi IgG IFA
Test Panels: Lyme Disease
Immunoserology of Lyme Panel A
Immunoserology of Lyme Panel B
Test Panels: Babesiosis
Babesia cePCR (Culture enhanced)
Test Panels: Bartonellosis
Bartonella cePCR (Culture enhanced)
Test Panels: Ehrlichiosis
Test Panels: Rickettsiosis
Rickettsia cePCR (Culture enhanced)
Test Panels: Tick-Borne Relapsing Fever (TBRF)
RFB & Bbsl cePCR (Culture enhanced)
Test Panels: Multiple Tick-Borne Diseases
Test Panels: Co-Infections
Test Panels: Culture
Borreliosis cePCR Test Panel
Test Panels » Borreliosis (Lyme and TBRF)
iGenex offers testing for lyme disease, relapsing fever, and other tick-borne illnesses.
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