Archives: Press Releases

IGeneX Supports HHS Initiative with Regulatory Expertise for Lyme Disease Diagnostics

December 18, 2024 – Milpitas, CA – IGeneX, a leader in innovative diagnostic solutions for tick-borne diseases, proudly announces its significant contribution to the U.S. Department of Health and Human Services (HHS) as part of the NOIS2-192 project. This effort, aimed at advancing Lyme disease diagnostics, underscores IGeneX’s commitment to supporting public health initiatives and ensuring access to high-quality diagnostic tools.

As part of the NOIS2-192 project, IGeneX provided an extensive regulatory document prepared in alignment with the FDA’s 510(k) submission process for in vitro diagnostic (IVD) devices. The document, developed using the FDA’s eSTAR (electronic Submission Template and Resource) format, serves as a comprehensive framework for ensuring compliance with stringent regulatory requirements. It includes detailed device descriptions, labeling, performance testing summaries, and data validation methodologies.

“IGeneX is dedicated to advancing Lyme disease diagnostics through rigorous scientific research and regulatory compliance,” said Dr. Jyotsna Shah, PhD, President and Laboratory Director at IGeneX. “By contributing this document to the HHS initiative, we are helping to streamline the regulatory process and ensure that innovative diagnostic tools meet the highest standards of accuracy and reliability.”

The provided document delivers critical value to the NOIS2-192 project, including:
• Regulatory Alignment: Offers a structured approach to meeting FDA requirements for Lyme disease diagnostics.
• Data Validation: Includes methodologies for assessing device performance characteristics, such as specificity, reproducibility, and stability.
• Streamlined Submissions: Serves as a template for efficient and compliant 510(k) submissions.
• Collaborative Framework: Enhances stakeholder collaboration by providing a robust regulatory roadmap.

IGeneX’s contribution highlights its leadership in Lyme disease diagnostics and its unwavering commitment to supporting HHS’s goal to combat tick-borne diseases. This effort aligns with IGeneX’s broader vision of empowering healthcare providers and patients with reliable, cutting-edge diagnostic tools.

For more information about IGeneX’s innovations and contributions to Lyme disease diagnostics, visit www.IGeneX.com.

About IGeneX, Inc. IGeneX, Inc. is a leading provider of advanced diagnostic testing for tick-borne diseases, including Lyme disease, Babesiosis, and Bartonellosis. With over 30 years of experience, IGeneX is committed to delivering accurate, timely, and comprehensive testing solutions to support patient care and advance public health initiatives.
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Lyme ImmunoBlot receives FDA clearance

Newly-cleared test is a game changer for the diagnosis of an often debilitating disease.

MILPITAS, Calif., September 4, 2024 – ID-FISH Technology, Inc., a leading provider of diagnostic tools for the detection of tick-borne diseases, today announced that its Lyme ImmunoBlot test has received FDA clearance. The name of the test is iDart™ Lyme IgG ImmunoBlot Kit.

The iDart Lyme IgG ImmunoBlot Kit is a stand-alone test for the detection of IgG antibodies against Borrelia-causing Lyme disease. The iDart ImmunoBlot Kit features 31 Lyme antigen bands, which are more antigen bands than any other Lyme immunoblot test on the market. Moreover, it is the only immunoblot that includes Osp A (P31) and Osp B (P34).

The inclusion of 31 antigens improves the sensitivity of the detection of Lyme-specific IgG antibodies, which in turn will improve the sensitivity of the diagnosis of Lyme disease in suspected patients without sacrificing specificity.

“We are delighted to have received FDA clearance for our Lyme ImmunoBlot Kit,” said Dr. Jyotsna Shah, PhD., Chief Scientific Officer of ID-FISH Technology. “The R&D team at ID-FISH has worked tirelessly on making sure that we deliver the most accurate test possible for the detection of Lyme disease. We look forward to working with partners to get these tests to patients who need a correct diagnosis.”

ID-FISH Technology plans to start shipping kits in the fourth quarter. Its primary customer base will be laboratories looking to get into Lyme disease testing or those who would like to add the iDart ImmunoBlot technology to their test menu. IGeneX, Inc., a specialty testing lab located in Northern California, has been using the ID-FISH Lyme IgG ImmunoBlot strips in their Laboratory-Developed Lyme ImmunoBlot IgG Assay since 2017.

Key features of the iDart Lyme IgG ImmunoBlot Kit

• A standalone test with the following band reading criteria: LSA band plus one or more bands from at least two of the following groups: P93, P41, P39, P23, P31 and P34. It’s not the CDC criteria of ELISA + 5/10 Bands.
• Only kit that includes 31kDa (OspA) and 34kDa (Osp B) recombinant proteins.
• Includes additional recombinant protein variants in each group.

Lyme disease is one of the fastest-growing infectious diseases in the United States. Around 475,000 people are diagnosed with Lyme disease annually in the US. It is caused by Borrelia burgdorferi, a type of bacteria carried by deer ticks. Lyme disease symptoms include fever, headache, fatigue, chills, joint and muscle pain, and, in some instances, the presence of a rash.

ID-FISH Technology would like to thank the Bay Area Lyme Foundation, the Centers for Disease Control and Prevention, and IGeneX for providing the samples for the study. The FDA review team was also instrumental in their guidance and advice throughout the review process.

For more information on ID-FISH Technology and the iDart Lyme IgG ImmunoBlot Kit, please visit https://idfishtechnology.com.

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About ID-FISH Technology, Inc.

Since 2004, ID-FISH Technology, Inc. has been a leader in the development of diagnostic assays for the detection of infectious diseases in clinical samples. ID-FISH has pioneered a number of assays for the detection of Malaria, Lyme disease, and Tick-Borne Relapsing Fever. ID-FISH has also been awarded numerous grants from the Small Business Innovation Research project. These grants have enabled the company to patent its technology and develop FDA-approved test kits.

Free Drive-Thru COVID-19, Flu, RSV Testing in Bay Area

MILPITAS, Calif., Dec. 6, 2022 — Experts are concerned that RSV, coupled with COVID and the flu, may result in what’s being dubbed as a “tripledemic” this winter. An uptick in flu, RSV and COVID cases is already leading to more hospitalizations in the Bay Area and across the U.S. Nationwide at least 78,000 people have been hospitalized with the flu; 4500 people have died.

IGeneX Laboratory, a leading provider of testing for hospitals, employers, and professional sports teams, has introduced combo testing for COVID-19, flu and RSV at its drive-thru facility in Milpitas. The test requires only one nasal swab, and detects all three illnesses.

Although many people have been vaccinated against COVID-19 and the flu, it’s clear, due to uncertainty surrounding vaccine immunity, that testing will play a critical role in ensuring safety across many aspects of life. Moreover, there is currently no vaccine for RSV, so testing remains the best way to determine exposure.

Highlights of the Drive-Thru Testing Program

• Appointments are available every 5 minutes, M – F, 8:30am – 1pm
• Testing is free with all insurances
• Patients are in and out in 5 minutes
• Results are provided in 24 hours

For more information on how to get tested, please contact IGeneX today at 1-800-832-3200 or visit igenex.com.

Lab Introduces COVID-19, Flu, RSV Combo Test

MILPITAS, Calif., Nov 2, 2022 — IGeneX Laboratory, a leading COVID-19 testing provider for hospitals, assisted living facilities, and professional sports teams, has added Flu and RSV testing to its test menu. The company is offering a single test, requiring only one nasal swab, that detects all three illnesses.

Experts are concerned that RSV, coupled with COVID and the Flu, may result in what’s being dubbed as a “tripledemic” this winter. While most cases involving COVID, Flu and RSV are likely to be mild, the viruses combined could result in millions of Americans falling ill, which could overload hospitals, according to a recent report from The New York Times.

Although many people have been vaccinated against COVID-19 and the Flu, it’s clear, due to uncertainty surrounding vaccine immunity, that testing will play a critical role in ensuring safety across many aspects of life. Moreover, there is currently no vaccine for RSV, so testing remains the best way to determine exposure.

“IGeneX is pleased to offer COVID, Flu, and RSV testing for our customers,” says Dr. Jyotsna Shah, President and Laboratory Director at IGeneX. “This is something we have been asked for repeatedly this year, as cases of both the Flu and RSV continue to rise.”

The 2022-2023 Flu season is shaping up to be more severe than in the past few years. Even before Flu season began, back in spring 2022, cases of Influenza began trending well above average for the past three years, reaching nearly 950,000 cases weekly by mid-October (compared to around 400,000 at the same time in 2019, just before the pandemic began).

Likewise, some hospitals are reporting an increase in the number of patients becoming infected with respiratory syncytial virus (RSV), which is akin to the common cold. Although adults and older healthy children typically only experience mild symptoms from the illness, children under 5, and seniors that may have weak immune systems, are at risk for more severe infection.

How to Order the COVID-19 + Flu + RSV Combo Test
1. Contact IGeneX at 1-800-832-3200 or at igenex.com to learn more about the test and pricing. In many cases, insurance or Medicare will cover the cost of testing.

2. IGeneX will provide test kits free of charge, as well as guidance on how to collect specimens and organize transportation of specimens to IGeneX.

3. Results will be provided between 24-36 hours after receipt of samples. Results will be reported to County and State Health Departments where required.

The COVID-19 + Flu + RSV Combo Test uses TaqMan SARS-CoV-2, Flu A/B and RSV RT-PCR Assay Kits in conjunction with the MagMAX Viral/Pathogen Nucleic Acid Isolation Kit from Thermo Fisher. Real Time RT-PCR assays are performed and results are interpreted using the Applied Biosystems QuantStudio 12 Real-Time PCR Instrument for detection of SARS-CoV-2, Flu A/B and RSV specific RNA in clinical samples.

For more information on how to get tested, please contact IGeneX today at 1-800-832-3200 or visit igenex.com.

Late Lyme Disease Detection Leads to Multiple Joint Replacement Surgeries

MILPITAS, Calif., October 13, 2022 — Over the years, Meghan Bradshaw had seen dozens of doctors at some of the most prominent medical institutions across the country. She was seeing everyone from gastrointestinal specialists, urologists, rheumatologists, and internal medicine doctors. But nobody could figure out her condition.

It got to a point where Bradshaw was completely debilitated. Her knees began filling up with fluid. Her doctor diagnosed her with rheumatoid arthritis, which is the closest thing he could think of to explain her “mystery” illness. She had to have her hips replaced at 26 years old.

But luck would begin to change for Bradshaw when a functional medicine doctor began asking questions about her upbringing. Upon discovering Bradshaw was from New Jersey, where blacklegged ticks are extremely common, her doctor thought she might have Lyme disease, and suggested she be tested.

Bradshaw chose to be tested at IGeneX, a private California-based lab that specializes in tick-borne diseases. “IGeneX has a great reputation in tick-borne infection testing, and is definitely a more accurate option for a patient to choose,” said Bradshaw. “My doctor helped me understand that [other] testing options are just highly inaccurate.”

Test results from IGeneX confirmed that Bradshaw had Lyme disease. “I learned that the missing piece of the puzzle was that it was tick-borne illnesses all along. This was a really overwhelming finding for me. It was a great sense of relief because I finally felt validated in everything that I had been experiencing.”

The Importance of Early Detection
Meghan Bradshaw has now had 16 of her joints reconstructed and eight joint replacements, all because of the late detection of Lyme disease. Her story has been widely reported in media such as Today, Daily Mail, and Insider, and is a clear example of the importance of early and accurate tick-borne disease diagnosis.

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. Most experts agree that the best patient outcomes are achieved when these 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 severe or chronic health issues,” says Dr. Jyotsna Shah, President of IGeneX. “That can lead to years of escalating costs for patients and their families due to ongoing doctor visits, diagnostic tests, medications, and other medical expenses.”

IGeneX surveyed 198 of its patients about their experience dealing with a tick-borne disease, and the results were stunning. According to the survey:

• 45% of patients needed more than three years to obtain the proper diagnosis
• 36% of patients spent more than $10,000 on tests, treatments, appointments, and other costs
• 65% of patients were forced to quit a job or cut back on their hours due to their symptoms24% 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

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 video profile of Meghan Bradshaw conducted by IGeneX in May 2022, please go here. For more information on tick-borne diseases and how to get tested, please visit www.igenex.com or www.cdc.gov.

IGeneX Introduces Highly Accurate ImmunoBlot Tests for Babesia

MILPITAS, Calif., August 19, 2022 – IGeneX, a leading tick-borne disease testing lab, is pleased to announce the availability of ImmunoBlot testing for Babesia. The Babesia ImmunoBlot tests for the Babesia genus and speciates to multiple species of Babesia that commonly infect humans, including B. microti and B. duncani.

Most serological tests for Babesia have poor sensitivity and have not been able to detect many of the ever-growing list of species and strains. With the new IGeneX Babesia ImmunoBlots, sensitivity is superior without compromising specificity of the test.

“We are delighted to bring the ImmunoBlot technology used for Lyme disease and COVID-19 to Babesia,” said Dr. Jyotsna Shah, PhD, President and Laboratory Director of IGeneX. “Without accurate, multi-species tests that detect infection at all stages of disease, patients are unable to get a correct diagnosis and can’t get better.”

What is Babesia?
Babesia is a tiny parasite that infects red blood cells, making it very much like malaria. Infection with Babesia is called babesiosis. The parasitic infection is usually transmitted by a tick bite. Babesiosis often occurs at the same time as Lyme disease because the tick that carries the Lyme bacteria can also be infected with the Babesia parasite.

Human babesiosis infection may cause fever, chills, headache, nausea, vomiting, and/or muscle aches (myalgia). Symptoms may be mild in otherwise healthy people; in addition, some infected individuals may exhibit no symptoms. In some cases, Babesia can be fatal.

Babesia is Widespread
Cases of Babesia are now confirmed to be present in all 50 states. There are two main reasons for this: an increase in ticks and travel. Due to ecological change and climate change, the hard-bodied Eastern black-legged ticks that carry Babesia have migrated away from historically common areas such as the Northeast and Upper Midwest. In addition, recent data suggest that the Brown Dog Tick can transmit less common strains of Babesia, including Babesia vogeli and Babesia canis.

IGeneX data also shows that patients positive for Babesia often contract the disease during domestic travel. Moreover, due to international travel, cases of common European strains of Babesia, such as Babesia divergens, are appearing across the US.

Babesia May Be More Prevalent Than Lyme Disease
A study of 10,000 patients revealed that 37.3% were positive for Babesia, and 32.1% for Lyme disease. However, Lyme is generally considered more widespread than Babesia because it is more widely reported than Babesia, and Lyme figures include TBRF, as both diseases are caused by Borrelia.

The Importance of Testing for Babesia
Babesia is the most common Lyme disease co-infection, and therefore testing is recommended if being tested for Lyme. The Babesia ImmunoBlots will aid health care professionals in confirming exposure to Babesia.

Advantages of the Babesia ImmunoBlot
• Uses specifically created recombinant proteins and not proteins from cultures
• Unlike IFA, can detect multiple species in one test
• Detects the full spectrum of disease: early, active and late-stage
• Detects Babesia genus and speciates to B. microti and B. duncani
• Replaces the IFA
• Avoids the error prone process of visualizing slides through a microscope

Pricing for the Babesia ImmunoBlots is $225 for IgM and $225 for IgG, but through September 30th, each ImmunoBlot can be purchased for $160 if both are purchased at the same time. That is a savings of nearly 30%.

For more information on how to order IGeneX testing, please contact IGeneX today at 1-800-832-3200 or visit igenex.com.

Percentage of Positive COVID Tests Remains High in SF Bay Area

MILPITAS, Calif., June 29, 2022 – The COVID test positivity rate remained above 2% for the eighth consecutive week, according to analysis of approximately 100,000 patients from IGeneX, a COVID-19 testing lab based in the San Francisco Bay Area of California. That is up from a prior weekly average of .60%.

These new figures come as California health officials continue to wrestle with the pandemic’s latest wave, which began a couple of months ago after the worst of the Omicron wave subsided. It is too soon to say whether this is an issue that goes beyond the Bay Area, but it seems to dash hopes that California is out of the COVID woods just yet.

“To see the positivity rate remain consistently high is concerning,” says Dr. Jyotsna Shah, PhD., President of IGeneX, Inc. “And it’s not just from one segment of patients. Positives are coming from young kids, hospitals, patients at elderly care facilities, and local employers.

IGeneX has been providing COVID-19 testing for major hospitals, schools, employers, airline travelers, and professional sports teams across Northern California since April 2020. The company has tested hundreds of thousands of patients and is still testing thousands per week. IGeneX uses RT-PCR tests for all COVID tests. RT-PCR tests are much more accurate than rapid antigen tests and ensure that patients receive the most accurate results.

Luckily, there is reason to be optimistic. “Fortunately, the percent positive rate is still lower than it was during the peak of Delta or Omicron, when there were weeks averaging above 5%,” says Dr. Shah. “Further, the subvariants of Omicron that we are observing do not appear to cause severe illness and death in as many individuals.”

Though conditions now are nowhere near as distressing as earlier in the pandemic, officials and experts say some protective measures are warranted during periods of elevated coronavirus spread and the uncertainty around both long COVID and the impact of new variants. These measures include continuing to mask up, washing your hands, social distancing, and prioritizing vaccinations and boosters.

For more information on COVID-19 testing from IGeneX, please visit https://www.igenex.com.

IGeneX and Kelley Flanagan Tackle Tick-Borne Disease as Cases Climb by 59% in the United States

Bachelor Nation’s Kelley Flanagan reveals how finally receiving a tick-borne disease diagnosis through IGeneX Lab changed her life for the better

Like hundreds of thousands of Americans, Kelley Flanagan developed mysterious health symptoms with, seemingly, no answers, that began in fourth grade but increased after her season of The Bachelor. After a diagnosis of Lyme Disease in 2021 via IGeneX Lab, she joined the over 300,000 (Bay Area Lyme Foundation) new patients each year that contract Lyme Disease, and began to discover just how deeply tick-borne disease can affect each facet of your life. Further, without effective diagnosis and treatment, symptoms can often worsen and progress into severe and even life-threatening health issues.

“[My brother] started doing so much evidence-based research, whether it was reading books, podcasts, documentaries… anything he could find that pertained to Lyme disease. That’s when he figured out that [he] most likely had Lyme disease. [My brother] was the one to say, ‘I think you have Lyme.’ After I came back from the show, I just knew something was wrong. It was around 4th grade when I noticed something was wrong- my digestion was off. It actually took my brother, Tom, to figure out that he had Lyme… because he goes hunting and got bit by a tick,” Flanagan told IGeneX recently.

Speaking with IGeneX in May of 2022 during Lyme Disease Awareness Month, Flanagan opened up about why she chose to be tested for Lyme with IGeneX: “The test that I found was the most accurate when I was doing all my research was, IGeneX. When it came to me getting tested, there were essentially no other options. I knew what was out there… IGeneX is the best on the market.”

IGeneX prides itself on testing for not only more relevant strains of tick-borne pathogens than any other lab, but even for pathogens that exhibit Lyme-like symptoms but arise from a different tick-borne disease. These often require different treatment paths- like common co-infections Babesiosis, Bartonella and Relapsing Fever. Fortunately, IGeneX’s ImmunoBlot boasts a sensitivity rate that is nearly double that of the standard two-tier testing protocol.

Flanagan has been on the up and up since her initial diagnosis in 2021. Flanagan recently told IGeneX that mindset is key in her health journey: “I knew I was in a space where my body wasn’t doing well. I know that it gets a little bit hectic to talk about it [Lyme Disease] constantly and that is something that I struggle with. Mindset is a huge thing for me and I want to focus on being a little bit more healthy instead of focusing on the downfalls.”

“Without accurate, multi-species tests that detect infection at all stages of disease, patients are unable to receive a correct diagnosis and cannot begin to get better. I speak for the entire IGeneX team when I say that we are grateful for Kelley’s continued advocacy around accurate tick-borne illness testing,” said Dr. Jyotsna Shah, PhD, President and Laboratory Director of IGeneX.

Founded in 1991, IGeneX is at the forefront of Lyme and tick-borne disease research. The two-tier ELISA/Western Blot testing recommended by the CDC uses outdated result criteria developed in 1994, leading to many missed infections and preventable suffering. In contrast, the IGeneX ImmunoBlot, which detects eight strains of Borrelia, produces a higher sensitivity, and remains the most comprehensive testing for Lyme disease antibodies.

PREMIER TICK-BORNE DISEASE TESTING LAB, IGeneX and KELLEY FLANAGAN RAISE AWARENESS FOR TICK-BORNE DISEASE

Kelley Flanagan shares how accurate tick-borne disease testing through IGeneX Lab led to her Lyme Disease diagnosis.

IGeneX, a leading tick-borne disease, and COVID-19 testing lab, is pleased to announce its recent alliance with Bachelor alum and tick-borne illness advocate, Kelley Flanagan. The partnership arose organically, following Kelley’s Lyme disease diagnoses through IGeneX testing in 2021. The two have joined forces leading up to Lyme Awareness Month to bring attention to a critical second pandemic- Lyme and tick-borne disease- encouraging individuals to get tested.

After experiencing years of mystery symptoms, and feeling “that my body is super sensitive and I’ve always known something was a little bit off,” Kelley underwent a series of intensive tests, and discovered she was suffering from Lyme disease and several co-infections in August of 2021. Kelley has shared her struggles with her community of fans in hopes of inspiring others to seek answers for their own mystery symptoms.

Founded in 1991, IGeneX is at the forefront of Lyme and tick-borne disease research. The two-tier ELISA/Western Blot testing recommended by the CDC uses outdated result criteria developed in 1994, leading to many missed infections and preventable suffering. In contrast, prepared from two strains of B. burgdorferi, the IGeneX ImmunoBlot produces a higher sensitivity and the most comprehensive testing for Lyme disease antibodies.

“We are thrilled that IGeneX could provide Kelley the answers to her pain, and we are grateful for her friendship in helping us educate the general public of tick-borne disease, and the IGeneX advantage” said Dr. Jyotsna Shah, Ph.D., President and Laboratory Director of IGeneX. “We are confident that together we can truly impress the necessity of testing on individuals, and hopefully, help a great deal of people on their healing journey.”

In celebration of Lyme Disease Awareness Month this May, Kelley will be offering limited exclusive interviews this Spring. If you are interested in speaking with Kelley, please reach out to Alex Moresco at alex@amorescopr.com.

IGeneX, a Premier Covid-19 Testing Lab, Offers RT-PCR Tests For Holiday Travelers Amidst Omicron Outbreak

MILPITAS, Calif., Dec. 20, 2021 /PRNewswire/ — IGeneX, a leading tick-borne disease and COVID-19 testing lab, is pleased to share testing tips and recommendations to help keep US Citizens healthy, and prevent the spread of the recently discovered Omicron variant amidst upcoming holiday travel from leading COVID-19 expert, Dr. Jyotsna Shah, PhD. Follow these testing best practices to ensure that you and your loved ones aren’t spreading anything but joy this holiday season!

“Traveling over the holidays can be challenging in the best of times, let alone during a pandemic,” said Dr. Jyotsna Shah, president of IGeneX, Inc. “Your holiday travel should now include taking an accurate COVID-19 test.” While many international destinations require proof of a negative COVID-19 test for entry, this should also be adopted within the US for state-to-state travel.

Unfortunately, not all COVID-19 tests are created equal, and not all tests are accepted at certain destinations that require proof of a negative test for entry. With the arrival of the Omicron variant, being tested accurately and consistently is key. The CDC expects that anyone with the Omicron infection can spread the virus to others, even if they are vaccinated or asymptomatic. The CDC states that full vaccination will aid in preventing hospitalizations and death.

While RT-PCRs were viewed as being more labor intensive, IGeneX offers RT-PCR tests that are accurate, convenient, and painless. IGeneX’s RT-PCR tests will ensure that you receive the most accurate results, particularly if you are asymptomatic. The SARS-CoV-2 Real-Time RT-PCR test detects the presence of SARS-CoV-2, the virus that causes COVID-19. If positive, the patient can be quarantined and treated before the disease spreads.

IGeneX provides a quicker turnaround on RT-PCR tests: “Since the pandemic began, we have been scaling up our infrastructure to the point where we can now offer results at a much faster speed while still maintaining a high level of integrity and accuracy,” said Dr. Shah. “We strongly recommend travelers choose an RT-PCR COVID-19 test due to higher accuracy for diagnosis of COVID-19,” said Dr. Shah.

With the arrival of new COVID-19 variants, testing this holiday season is critical. We are seeing climbing levels of breakthrough cases in vaccinated individuals, and we do not have enough peer reviewed data to confidently say how the vaccines will protect against the Omicron variant in the future. However, timing is absolutely critical when testing for COVID-19. We recommend getting tested within 24 hours of your travel.