Archives: Press Releases

New York State Grants Approval for IGeneX’s Newly Developed Tick Borne Relapsing Fever (TBRF) ImmunoBlot Tests

MILPITAS, Calif., Oct. 8, 2019 — The Division of Laboratories of the Department of Health of the State of New York has approved IGeneX’s newly developed Tick-Borne Relapsing Fever (TBRF) ImmunoBlots (IgM and IgG), making them immediately available to New York practitioners.

Until recently, diagnostic tests for TBRF have been grossly insensitive and have not been able to detect many of the ever-growing list of species and strains of TBRF Borrelia carried by hard and soft ticks. The new IGeneX ImmunoBlots overcome these obstacles with the ability to detect antibodies to TBRF Borrelia species including, but not limited to, B. hermsii, B. miyamotoi, and B. turicatae.

TBRF is often considered a Lyme disease imitator because both TBRF and Lyme sufferers display many similar symptoms, such as high fever, chills, and headache, often leading to misdiagnosis. Moreover, some of the Borrelia that cause TBRF are transmitted by the same ticks that transmit B. burgdorferi, the causative agent of Lyme disease. Therefore, it is important for physicians to test for both TBRF and Lyme.

“We are very excited to be able to offer the TBRF ImmunoBlots to physicians in New York State,” said Dr. Jyotsna Shah, President of IGeneX. “Doctors use to call me and say ‘my patients have Lyme-like symptoms. Why are your tests negative?’ We now know that their symptoms might have been due to TBRF Borrelia infection. These new TBRF ImmunoBlot tests will help patients in this group, as well as patients with Lyme and TBRF Borrelia mixed infections.”

The accuracy of the TBRF ImmunoBlot has been established. The specificity is 98.5% for IgM and IgG based on a study performed on 212 well characterized samples, of which 50 were provided by the CDC. Additionally, the TBRF ImmunoBlots can detect the full spectrum of disease: early, active and late-stage disease.

For more information on IGeneX and the TBRF ImmunoBlot tests, please visit https://igenex.com.

About IGeneX
For over 25 years, IGeneX has been at the forefront of research and development of diagnostic testing for Lyme disease, TBRF, Bartonella, and other tick-borne diseases. IGeneX arms its talented scientists with the most cutting-edge technology available to enable them to find new solutions that challenge the status quo of testing for Lyme and associated tick-borne diseases. The mission of IGeneX is to aid practitioners in their diagnosis of tick-borne illnesses by providing the most comprehensive testing possible. Learn more at: www.igenex.com

The Staggering Cost of Lyme Disease and Other Tick-Borne Illnesses

MILPITAS, Calif., July 10, 2019 — Nearly 36 percent of patients with a tick-borne disease spent more than $10,000 on tests, treatments, appointments, and other costs associated with their disease, a new IGeneX survey found.

The survey analyzed the cases of 198 patients from 2018 and 2019 who were tested by IGeneX, a leading testing lab in California. Researchers sought to determine how long it took for patients to obtain a proper diagnosis, how many doctors they had visited, and how much financial impact they had ultimately incurred.

According to the survey:

• 45% of patients needed more than three years to obtain the proper diagnosis
• 65% of patients were forced to quit a job or cut back on their hours due to their symptoms
• 24% of patients saw more than ten doctors before receiving a proper diagnosis
• 86% of patients suffer from long-term side effects from not having been diagnosed sooner

***

Most experts agree that the best patient outcomes are achieved when Lyme disease and other tick-borne diseases are diagnosed and treated as early as possible. “When a tick-borne illness is misdiagnosed, the disease-causing infection has more time to spread, which can lead to more severe or chronic health issues,” says Dr. Jyotsna Shah, President of IGeneX. “That can lead to months and even years of escalating costs for patients and their families due to ongoing doctor visits, diagnostic tests, ineffective medications, and other medical expenses.”

Tick-borne diseases are on the rise and prevention should be on everyone’s mind, particularly during the spring, summer, and early fall when ticks are most active. Prevention and early detection are part of the safety protocol extended by the Centers for Disease Control and Prevention.

Researchers hope that the survey will help educate the public on the risks associated with delaying testing or relying on old testing techniques. “In our view, many patients are missed because much of the testing recommended by general practitioners is based on technology from 25 years ago,” says Dr. Shah. “Science has progressed, and we can now give patients a much more accurate diagnosis than was available years ago.”

For an infographic of key findings from the survey, please go here. For a complete view of the survey results, please go here. For more information on tick-borne diseases and how to get tested, please visit www.igenex.com or www.cdc.gov.

Are Your Child’s Symptoms Consistent with Lyme Disease?

The Importance of Monitoring Your Kids for Tick-Borne Diseases

MILPITAS, CA, May 13, 2019 — Dave Holt knew something was wrong. His daughter, Lucy, a talented soccer player and all-around normal, active, and outgoing 12-year-old girl, was not herself. She had stopped running fast on the soccer field and had started to come home from school and fall asleep in the middle of the day. This was not his daughter.

At first, Dave thought it might be just a phase, or something “in her head.” But as the problem persisted, he knew it had to be more serious. Dave and his wife took Lucy to a pediatrician who ran heart, blood, and lung tests, and found nothing wrong. It certainly wasn’t Lyme disease, they were told. This was a relief, but as the symptoms continued, they were convinced that something was legitimately wrong with Lucy and they knew they needed a second opinion.

Dave was persuaded by a friend who worked at IGeneX, a tick-borne-disease testing lab in California, that Lucy’s symptoms were typical of someone with Lyme disease. “Thank God I knew someone in the industry who could describe the symptoms to me,” said Dave. “At that point, I knew I needed to get her tested.” Dave and his wife had Lucy tested at IGeneX, and the tests confirmed the presence of both Lyme disease and Babesia in Lucy’s blood sample.

After the diagnosis, Lucy went to Pacific Frontier Medical, Inc. for treatment, and six months later she was cured. Today she is back to her normal self, competing in soccer and going on campouts and backpacking adventures. Lucy is once again a full-of-life teenager.

For a video of Lucy’s story of overcoming Lyme Disease and Babesia, please go here.

May is Lyme Disease Awareness Month
Lyme disease is the most common tick-borne disease in the US, affecting more than 300,000 people in the United States every year. Children are at the highest risk of acquiring Lyme disease, and the Children’s Lyme Network reports that at least 75,000 children are diagnosed with Lyme disease annually. In fact, more children are diagnosed with Lyme disease each year than all combined cases of pediatric cancer, type 1 diabetes, cystic fibrosis, and epilepsy.

A child or teenager is more at risk for Lyme disease during the spring and summer months, when school is out and ticks are more active. Ticks live in wooded areas, low-growing grasslands, and yards where kids typically congregate. “Young people are more at risk in these places, or around a pet that has been in these areas,” says Dr. Jyotsna Shah, President of IGeneX. “Parents need to caution their children on where to go, and should monitor them for any potential Lyme-like symptoms.”

Lyme disease in the US is primarily caused by a bacterium called Borrelia. This bacterium is transmitted to humans through the bite of infected blacklegged ticks. Typical symptoms of Lyme disease include fever, headache, fatigue, and a skin rash that has a characteristic bullseye appearance. The symptoms of Lyme disease can be so debilitating for young people that participating in school and youth activities is nearly impossible.

For more information on Lyme disease and how to get tested, please visit www.igenex.com or www.cdc.gov. For an infographic of Lyme Disease statistics, please go here.

Contact:
Joe Sullivan
Head of Marketing
IGeneX, Inc.
jsullivan@igenex.com
408-504-7691

May Might be Lyme Disease Awareness Month, but is Relapsing Fever the Bigger Threat?

MILPITAS, Calif., April 29, 2019 — Tick-Borne Relapsing Fever (TBRF) is a very common tick-borne disease in California. It is often confused with Lyme disease because the two diseases present similar symptoms. But what many people don’t know is that in California, TBRF affects nearly as many people as Lyme disease, and is growing at a faster rate.

Some of the Borrelia that cause TBRF are transmitted by the same ticks that transmit B. burgdorferi, the causative agent of Lyme disease. Until recently, TBRF was thought to be very limited in the United States, but a 2018 study published in the prestigious International Journal of General Medicine confirms that exposure is widespread on the West Coast. In blood samples drawn from patients in 24 California counties, tests resulting in positive results for TBRF were found in 16 counties, with the highest rates of positive results in Santa Clara, Alameda, Marin, and San Francisco counties.

In addition, the study found that Ixodes pacificus, or the Western Blacklegged Tick, has been found in 56 of 58 California counties. While more common in the California North Coast and on the western slopes of the Sierra Nevada, they are also found in Southern California mountains, foothills, and near wetlands and bodies of water.

“Detection techniques for Relapsing Fever Borrelia are limited due to the diversity of this species group and the difficulty in culturing these bacteria,” says Dr. Jyotsna Shah, co-author of the study and President of IGeneX, a leading tick-borne disease testing laboratory. “Using novel laboratory techniques, we were able to detect exposure to Relapsing Fever Borrelia.”

Patients with “Lyme-like” musculoskeletal, neuropsychiatric, or cardiovascular symptoms in California should be screened for TBRF. A negative Lyme test does not rule out the presence of TBRF, and clinicians should be familiar with disease symptoms and available diagnostic tests. IGeneX tests for all the major strains of the TBRF Borrelia, including B. hermsii, B. miyamotoi, B. turicatae, B. texasensis, B. coriaceae, and B. parkerii.

Tick-borne diseases are on the rise and prevention should be on everyone’s mind, particularly during the spring, summer, and early fall when ticks are most active. Prevention and early detection are part of the safety protocol extended by the California Department of Public Health, the Centers for Disease Control and Prevention, as well as vector control and county health departments.

For an infographic that highlights the threat of TBRF in California, please go here. For more information on tick-borne diseases and on how you can get tested for TBRF, please visit www.igenex.com or www.cdc.gov.

Contact:
Joe Sullivan
Head of Marketing
IGeneX, Inc.
jsullivan@igenex.com
408-504-7691

IGeneX Inc. Introduces Newly Developed, Highly Sensitive Tests For Rapid Diagnosis of Bartonella Infections

PALO ALTO, Calif.–(BUSINESS WIRE)–IGeneX is excited to announce the availability of their newly-developed, advanced testing methods to aid in the diagnosis of patients infected with Bartonella, an emerging epidemic with potentially disabling and life-threatening consequences.

Despite the rising incidence of Bartonella, until now diagnostic tests for these organisms have been grossly insensitive and have not been able to detect many of the ever-growing list of species and strains known to exist. Currently, available serological and molecular tests lack sensitivity, can require repeated blood sampling, and may take weeks for results to be reported. The new IGeneX test methods have overcome many of these obstacles. “Thanks to countless hours of research, highly sensitive and widely inclusive testing is now available from IGeneX that will detect most of these clinically relevant, disease-causing Bartonella species,” said Dr. Shah, CEO of IGeneX.

Bartonella comprises a group of globally distributed and highly diverse alpha-proteobacteria that can infect a wide range of mammals. Over the last two decades, more than 30 species have been identified, and several have been associated with a diverse spectrum of cardiovascular, neurologic, obstetric and rheumatologic disease manifestations in animals and humans. These bacteria are transmitted by vectors such as fleas, ticks, lice, and biting flies, and can be accidentally transmitted by animal scratches, bites and needle sticks. Thus, individuals working or living with animals, or those with high exposure to fleas, ticks, lice, and biting flies are at high risk of acquiring the Bartonella infection.

New Testing Technology
Using information derived from DNA sequencing of PCR products of patients’ samples positive by Bartonella Genus PCR, the research team at IGeneX developed the newly available Bartonella Western Blots and the Bartonella IgXSpot, an Enzyme-linked ImmunoSpot assay.

The Bartonella Multi-Species Western blot detects Bartonella genus-specific IgM and IgG antibodies in human serum or plasma. Also, it will identify and differentiate B. henselae, B. vinsonii, B. quintana and B. elizabethae.

The Bartonella IgXSpot is an Enzyme-linked ImmunoSpot assay that detects human T-cells reactive to Bartonella specific antigens in vitro. The Bartonella IgXSpot will detect specific T-cell responses very early – soon after the onset of infection – when antibodies to the organisms are not yet detectable, as well as late in the disease when the levels of antibodies can be very low. It is also useful in patients who are immunosuppressed or who have an immunoglobulin deficiency. Hence, this assay is especially useful for seronegative patients.

These new tests are more sensitive, inclusive, and specific than currently available assays and will provide a diagnosis within just a few days.

“I always thought I was a hypochondriac. Doctors told me it was just ‘stress’ or ‘all in my head,’ but I finally figured it out and you can too. … The best lab to do this is called IGeneX.” –CF, a resident of California

Full-Spectrum Testing
When the Bartonella IgXSpot test is combined with Bartonella Western Blots, FISH and PCR testing, one can obtain information on the full spectrum of the patient’s immune response to the infection and stage of the disease.

New York State Grants Approval of IGeneX’s Newly Developed Lyme ImmunoBlot Tests

PALO ALTO, Calif.–(BUSINESS WIRE)–The Division of Laboratories of the Department of Health of the State of New York has approved IGeneX’s newly developed Lyme ImmunoBlots (IgM and IgG), making it immediately available to New York practitioners.

Now, instead of sourcing test antigens from only one or two species of sonicated Borrelia, the ImmunoBlot is comprised of specific recombinant antigens from several species of Borrelia burgdorferi. The ImmunoBlot therefore detects the following US and European species of Lyme Borrelia: B. burgdorferi B31, B. burgdorferi 297, B. mayonii, B. spielmanii, B. californiensis, B. valaisiana, B. afzelii and B. garinii and makes the P31 epitope confirmation test unnecessary.

To test for all the above Borrelia burgdorferi species by Western blots, eight individual IgM and eight individual IgG tests are required. Performing 16 Western blots on each patient sample is expensive and impractical as opposed to just two tests with the Lyme ImmunoBlots.

“The Lyme ImmunoBlot is intentionally more inclusive for Borrelia burgdorferi sensu lato than the currently available Western blots because we now know that other species such as B. mayonii, B. californiensis and B. spielmanii all cause disease in the US,” said Dr. Jyotsna Shah, CEO of IGeneX. “With the increase of international travel in the last 10 years, people can get infected at home, other parts of the US or Europe depending on their lifestyle. Thus, it is important to have available a test that can detect the infection irrespective of where it was acquired.”

More Comprehensive Detection
The Lyme ImmunoBlot IgM detects the five following recombinant protein groups: P93, P41, P39, P31, and P23. Furthermore, the Lyme ImmunoBlot IgG detects these twelve recombinant protein groups: P93, P66, P58, P45, P41, P39, P34, P31, P30, P28, P23, and P18.

High Accuracy Across the Disease Spectrum
The accuracy of the Lyme ImmunoBlot has been established by exhaustive testing. The sensitivity with well-characterized samples has been shown to be greater than 93% whereas the two- tier testing recommended by CDC has a sensitivity of about 57.6% (Waddell LA et al. PLoS ONE. 2016;11(12):e0168613. doi:10.1371/journal.pone.0168613). Additionally, the ImmunoBlots detect the full spectrum of disease: early, active and late-stage disease. This high degree of sensitivity does not come at the cost of specificity. The specificity of the Lyme immunoblot is equivalent to CDC 2-tier testing (ELISA or IFA followed by Western blots).

New York State Department of Health Approval
The Clinical Laboratory Evaluation Program, Wadsworth Center, New York State Department of Health has approved the IGeneX Lyme ImmunoBlot (https://www.wadsworth.org/igenex-inc-reference-laboratory-12), making it available to all qualified New York practitioners and their patients. IGeneX works swiftly to ensure that this remarkable test can be utilized immediately.

The Wadsworth Center, a division of New York State Department of Health, is a science-based community committed to protecting and improving the health of New Yorkers through laboratory analysis, investigations, and research, as well as laboratory certification and educational programs. The Center serves a vital role in the New York State Department of Health’s efforts to protect and promote the health of New York’s citizens.

IGeneX Inc. Introduces New Diagnostic Tests for Lyme Disease and Tick-Borne Relapsing Fever

PALO ALTO, Calif.–(BUSINESS WIRE)–IGeneX Inc., a CLIA and New York-approved Reference Laboratory, specializing in testing for tick-borne diseases, is pleased to announce the launch of three new tests that are more inclusive and specific for aiding in diagnosis of Borreliosis (Lyme Disease and Tick-Borne Relapsing Fever, Borreliosis).

“IGeneX’s new Lyme ImmunoBlot and the TBRF ImmunoBlot tests are the first, most inclusive and specific serological tests for Lyme disease and TBRF”

Borreliosis is caused by two groups of Borrelia, B. burgdorferi group and the Tick-Borne Relapsing Fever (TBRF) Borrelia group. Until recently, it was believed that B. burgdorferi group was the only group that caused Lyme-like symptoms. However, we now know that TBRF Borrelia also causes Lyme-like symptoms. Therefore IGeneX developed two sets of Immunoblots, Lyme ImmunoBlot IgM and IgG and TBRF ImmunoBlot IgM and IgG.

Many patients with Lyme-like symptoms are misdiagnosed because: (1) The current serological tests cannot detect antibodies to all the different strains of B. burgdorferi (2) For TBRF Borrelia, only two serological tests, an IFA test for B. hermsii and a serological test that detects only B. miyamotoi GlpQ protein, are available. In addition, with the increase in tick populations, Borreliosis is on the rise. Thus there is an urgent need for better diagnostic tests for Borreliosi.

Because symptoms of Lyme and Tick-Borne Relapsing Fever are often similar, a more comprehensive battery of tests is critical for proper diagnosis.

“IGeneX’s new Lyme ImmunoBlot and the TBRF ImmunoBlot tests are the first, most inclusive and specific serological tests for Lyme disease and TBRF,” said Dr. Jyotsna Shah, President and CEO of IGeneX. “These tests, when combined with Lyme IgX spot and PCR, cover the full spectrum of the disease.”

Lyme ImmunoBlots IgM and IgG

Although IGeneX Lyme Western blot prepared from Borrelia burgdorferi strains B31 and 297 is one of the most sensitive tests, it does not detect antibodies to all the B. burgdorferi sensu lato antigens. To develop all inclusive Western blots would be very expensive and impractical. Therefore, IGeneX has developed a Lyme ImmunoBlot that is very specific and inclusive of most species of B. burgdorferi sensu lato for clinical use with the following advantages over a Western blot:

The specificity of the ImmunoBlot is 98.0% for IgM and 98.7% for IgG. This is higher than the traditional Western Blot.
The 31kDa Epitope confirmation test will not be required on patient samples tested by Lyme ImmunoBlots.
The sensitivity of the Lyme Immunoblot is 90.9% with well-defined samples.
The ImmunoBlot has better sensitivity compared tothe current Western Blot, because it is designed to detect antibodies to major B. burgdorferi sensu lato specific antigens from North America and European strains as listed below:
B. burgdorferi B31
B. burgdorferi 297
B. californiensis
B. mayonii
B. afzelii
B. garinii
B. spielmanii
B. valaisiana

TBRF ImmunoBlots IgM and IgG

The TBRF ImmunoBlot is designed to detect antibodies to specific antigens of TBRF Borrelia in human serum. It detects antibodies to B. hermsii, B. miyamotoi, B. turicatae and B. coriaceae. Based on in-house studies these blots detect antibodies to North American, European and Australian strains of TBRF Borrelia in patient serum samples. The specificity of the TBRF ImmunoBlot is 94% and 98% for IgM and IgG respectively.

Lyme IGX Spot

The Lyme IGXSpot is an Enzyme-Linked ImmunoSpot (ELISPOT) assay that detects human T cells reactive to B. burgdorferi specific antigens in vitro. ELISPOT is a widely used method for detecting and monitoring cellular immune responses to specific antigens.

The Lyme IGX Spot test:

1. Detects specific T-cell responses soon after B. burgdorferi infection, when antibodies to the organisms are not detectable or late in the disease, when the levels of antibodies are very low.

2. When combined with Lyme ImmunoBlot tests, information on the full spectrum of patient’s immune response to infection and stage of disease is obtained.

3. Is especially useful for seronegative patients.