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FDA Puts Teal Health on an Accelerated Path to Market for our At-Home Cervical Cancer Screening
This is a Big Deal. Teal Health’s at-home cervical cancer screening has received FDA Breakthrough Device Designation, putting it on an accelerated path to market based on our ability to increase access to this life-saving screening.
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Meghna's Story: The Healthcare Gaps We Cannot See: Filling in Family History After An Unexpected Breast Cancer Diagnosis
It’s been almost 2 years since I was diagnosed with breast cancer, and a year and a half since my medical team declared me cancer-free. I was 29 years old, had just been married, and was in the final stretch of my doctorate program. Life stopped in that moment.
It’s been almost 2 years since I was diagnosed with breast cancer, and a year and a half since my medical team declared me cancer-free.
I was 29 years old, had just been married, and was in the final stretch of my doctorate program. Life stopped in that moment.
I vividly remember shriveling up, trying to disappear while my husband held me, as my doctor told us that a clinical trial was my best chance at defeating this stage 3c triple-negative tumor.
I was among the many women who delayed their cervical cancer screenings during the pandemic, and finally got an appointment in October 2022. A few days before, I had felt a lump in my breast. I didn’t think much of it. There was no known history of breast cancer in my family and I was young. But, as chance would have, it was a cervical cancer screening appointment that ultimately led to my breast cancer diagnosis.
After I pointed out the lump to the Nurse Practitioner conducting my cervical cancer screening, she felt it too and referred me to a breast specialist. I called both my insurance carrier and the specialist clinic, insisting I needed to be seen within the week, and the breast specialist diagnosed the cancer soon after.
In the weeks to come, an ultrasound, biopsy, MRI, PET scan, and mammogram (although, my dense breast tissue meant the mammogram was not as effective) all confirmed the tumor was there and had spread to a lymph node. During this diagnostic journey, I learned that my cancer was due to a BRCA 2 genetic mutation. The mutation was not as evident in my family, as it was passed down paternally for several generations, with few women to impact along the way (the main effects of BRCA 2 relate to ovarian and breast cancers).
Had I known, I would have been in specialized hereditary cancer care and surveillance since my early 20s – but that’s the thing about family medical history, often we simply don’t know.
Being unaware of family medical history is a common challenge for immigrants. As someone who has moved around several times, and the first in my family to immigrate to the United States, my family history knowledge is scattered. While my doctoral research focused on genetic testing experiences, there is little to no guidance for people of “South Asian” or “Indian” heritage to get tested for cancer genes (unless they are aware of a family history). Anytime I would ask for a breast screening, being frustratingly proactive about preventative healthcare, I was told ‘You’re too young.’ In many ways, I fell through a series of cracks.
Within 2 weeks of being diagnosed, I was getting my first chemotherapy infusion as a part of a clinical trial for high-risk breast cancers. I had the option to delay my infusions to freeze my eggs, but chose not to. I was overwhelmed knowing how aggressive my tumor was. I spent the next three months getting infusions and MRIs. Never had I imagined I would spend my 30th birthday or my first wedding anniversary bald, nauseous, in cancer treatment. But my goal was to persevere. I was in fight mode.
I was incredibly fortunate that the drugs used in the clinical trial worked – in January 2023, an MRI and biopsy confirmed that the cancer was gone.
In March 2023, I underwent a day-long surgery, a double mastectomy with reconstruction using tissue from my thighs. For four days, I recovered in the ICU. For five weeks I recovered at home, while my husband helped me re-learn how to move with a walker, emptied my surgical drains, and took care of my every need.
The rest of 2023 held five weeks of radiation, 13 rounds of immunotherapy infusions, and a 12-month course of pills – and many, many side effects. My skin endured severe burns from the radiation, which required intense wound care. I remember the nurse who changed my dressings each day saying that everyone missed the early signs of my brown skin burning (they were looking for ‘redness’ that one might expect on lighter complexions). My body was covered in allergic hives, a reaction to ongoing infusions. I ended up in the Emergency Room unable to breathe because the pills had greatly reduced my red blood cell count. But, despite everything, I had been declared “NED” (no evidence of disease), and I wanted to get through treatment to keep it that way.
I am immensely grateful for my stellar medical team, loving family, and unwavering community of friends and colleagues. My husband never let me feel helpless and took on the weight of my care with grace. Somehow, he made sure I still laughed, enjoyed my hobbies, and drew strength in each moment. Now, in close surveillance care, I still hold my breath before every scan and panic at a slight bodily ache, but knowing I am not alone makes a world of difference.
While I may wish breast cancer never happened, it has taught me every day to be grateful, find meaning in what I do, and cherish those around me. It has undeniably shaped me and the decisions I have made since. I joined Teal Health almost right after I completed my treatment, and I do not take for granted the opportunity to help eradicate cervical cancer.
This Breast Cancer Awareness Month, I will be celebrating 2 years of my diagnosis – celebrating, because getting screened and identifying the cancer was the start of my journey to get rid of it. If you are behind on your routine cancer screenings, please, get screened. If you don’t know your family medical history, talk to your doctor about testing for your health needs. And if this finds you going through your own diagnosis, know that you are not alone.
More than a Preference: For Those with Vaginal Syndromes, an Alternative to the Speculum is a Necessity
Certain health conditions make using a speculum excruciating and at times impossible. These include syndromes involving narrowing or tightening of the vaginal tissues, chronic vaginal pain, as well as lichen sclerosus, a chronic autoimmune vulvar skin disease.
A traditional cervical cancer screening requires a patient to lay on an exam table and place their feet into stirrups to hold their legs apart, while a provider inserts and expands a speculum into their vagina. This procedure, the status quo for cervical cancer screenings in the United States, can be distressing for many patients. As an at-home self-collected HPV test for cervical cancer, the Teal WandTM could offer an alternative to this traditional exam for those who cannot or prefer not to use the speculum.
While an alternative to the speculum may be a preference for many, it is a necessity for some. Certain health conditions make using a speculum excruciating and at times impossible. These include genitourinary syndromes involving narrowing or tightening of the vaginal tissues, chronic vaginal pain, as well as lichen sclerosus, a chronic autoimmune vulvar skin disease. These conditions can intensify with the physiological changes menopause brings, and make using a speculum very difficult if not intolerable.
When the Speculum is Not an Option
We recently spoke to Jennifer and Kristin, both women in their mid-50s, about their health conditions and inability to screen with a speculum. Jennifer experiences pain from a stenotic hymenal band (or, hymenal stenosis and fibrosis), while Kristin was diagnosed with chronic lichen sclerosus.
Hymenal stenosis and fibrosis is a rare condition where a fibrous ‘band’ develops on the hymen, making one’s vagina more sensitive and narrow. There is little research on this condition, but medical case studies note that symptoms may include pain with using tampons, intercourse, and recurring urinary infections. In most cases, the condition can only be resolved surgically, with a hymenectomy.
Lichen sclerosus affects up to 3% of the population, although prevalence is likely higher, since its symptoms are frequently misdiagnosed. It can cause a patient’s vulvar skin to thin and narrows their vaginal opening, so patients often experience tearing, inability to have sexual intercourse, pain during urination, constipation, itching, and soreness. If left untreated it can cause scarring that may lead to complete loss of one’s vulvar architecture. There is up to a 5% risk that lichen sclerosus evolves into vulvar cancers.
Dr. Liz Swenson, an OBGYN and Teal’s Medical Director, tells us, “Unfortunately, these situations are not that uncommon. Despite the range of speculum sizes, it can still be too painful for some women to tolerate. Even if they make it through the speculum exam it can still have a negative impact, causing some to put off that next visit.”
Unable to tolerate speculums, Jennifer and Kristin describe how an alternative to the current in-person speculum exam experience would make the difference between being able to participate in routine screening or falling behind and facing heightened risks.
Jennifer’s Story
Jennifer has been a midwife for almost 25 years and is passionate about her work. As a provider, she conducts cervical cancer screenings and has witnessed women struggle with the speculum time and time again. However, while Jennifer insists her patients should stay up to date on their screenings, she has not been able to do this for herself.
For Jennifer, traditional speculum exams are painful and have led her to delay her own screenings. Her last screening was almost 10 years ago, much longer than the current recommendations. “The advice I give to people as far as when they should have screenings, I am not following it - I'm terrible!”
Jennifer has seen several providers about her hymenal stenosis and fibrosis. She first began feeling this pain during perimenopause, around her 40s. However, it has worsened in the past several years as her vaginal tissue changed during menopause and she stopped being as sexually active. The various interventions, like estrogen creams, dilators, and surgical procedures, have not been suitable for Jennifer.
“A speculum exam, honestly, it’s somewhat like torture,” she tells me, as she explains that during her last screening she “basically whimpered and cried the whole time.” She dreads (and has thus delayed) her cervical cancer screening because of her vaginal tissue sensitivity.
“A regular speculum would be really, really uncomfortable, to a point where I don't even know if I would tolerate it.”
Using a self-collection device designed for all body types, with the convenience and comfort of being in one's own home is a critical option for someone like Jennifer. She not only struggles with the exam, but also with finding time on her days off as a healthcare provider. The added comfort would mean that Jennifer can screen without pain.
Kristin’s Story
Kristin was diagnosed with lichen sclerosus in 2009, making it extremely painful to screen with a speculum. She has not been screened for cervical cancer since 2019. Although, she did attempt a screening in 2023, where she tells me, “(My provider) wasn't able to get the speculum in, even the smallest size. So, we had to stop. It was just not going in.” After Kristin exclaimed in pain, the provider stopped and sent Kristin home without offering any screening alternatives.
Unfortunately, Kristin has often experienced dismissive and unsupportive healthcare. “There's just a lack of empathy [...]. I just feel like I'm just a number. [...] I do tell them about my disease, but I don't feel like there's a lot of information out there.” Her providers insist that her vagina will stretch with the speculum, despite the terrible pain.
“You know how they're like, ‘Spread your knees apart’? I could never do that. I was just like ‘No, I can't. It hurts. That’s as far as it goes.’ It just feels like I'm ripping!”
Kristin’s vaginal pain and narrowing intensified throughout menopause. She describes the feeling of enduring a speculum as “being stretched,” and that interventions like dilators do not work for the same reason.
Kristin desperately wants to stay on top of her screenings but does not know how, given that she cannot use a speculum. “From here, I'm not sure what to do.”
She adds, “Before I got diagnosed, I kept up to date with my screenings. […] This is the first time that I’ve let it lapse. [….] I tried. I know it’s still important to get tested. I want to get it done.”
Paving the Way Forward Requires More Screening Options
For both Jennifer and Kristin, the speculum is out of the question. Here, devices like the Teal Wand* offer a critical solution for engaging in routine cervical cancer screenings. Jennifer tells me, “Honestly, if the Teal device was available now I would do it, and I probably would be good about how often I have to do it.”
Kristin, in particular, looks forward to self-collecting at-home, where she can feel at-ease and in-control. At the clinic, Kristin says she is immediately “triggered, nervous, and upset.”
“Even when the doctor just touches me with the speculum, I tense up from my past experiences. But if I could just do it at home and take my time, take a bath and get relaxed, I could just go at my own pace and not feel rushed.”
While seeing providers in-person is important and needed at times, an in-person pelvic exam is not always called for during routine cervical cancer screenings. For some, like Jennifer and Kristin, self-collection is a necessity and can enable them to stay up to date on cervical cancer screenings.
For too long, women and people with cervixes have been made to accept that their healthcare is inevitably painful and a matter of endurance. However, providing alternatives can make all the difference between allowing people to readily participate in – versus indefinitely delaying – their life-saving cervical cancer screenings (when caught early, through screening, cervical cancer can be cured 92% of the time).
A seasoned midwife, Jennifer highlights, “Especially for women, it can feel like so many things are done to us, so doing it yourself feels great.” She adds, “that feeling that I have just taken charge of my own health and did this on my own? That’s wonderful.”
Thank you, Jennifer and Kristin, for being so generous with your time and perspectives. Teal Health is honored to share your stories.
*The Teal Wand is not yet FDA approved, but has been designated as a Breakthrough Device by the FDA, prioritizing its review
Lindsey’s Story: A Cervical Cancer Scare, Unanswered Questions, and Turning to Telehealth
Lindsey, a 26-year-old Black woman living in St. Louis, Missouri, tells me about her experience with an abnormal cervical cancer screening result, a colposcopy, and the many looming questions she had to navigate.
Lindsey, a 26-year-old Black woman living in St. Louis, Missouri, tells me about her experience with an abnormal cervical cancer screening result, a colposcopy, and the many looming questions she had to navigate. Through it all, Lindsey filled in information gaps for herself, as communicating with her in-clinic providers proved challenging – this is a barrier Lindsey hopes Teal’s telehealth platform, enabling consistent access to providers, can resolve.
The First ‘Abnormal’ Result
At the time of her screening, Lindsey was working as a restaurant server downtown and putting in any spare hours in her day to complete her law school applications. She describes this as an overwhelmingly stressful period in her life.
At first, Lindsey couldn’t shake the feeling that something felt ‘off’ – she had an IUD, which meant she did not get regular periods, but she was experiencing spotting that did not feel normal. It is important to trust ourselves to know when something doesn’t feel quite right with our body, and act on that feeling, as Lindsey did. At the clinic, she was informed that she needed to get a cervical cancer screening, as she was unaware that she was a year and a half overdue.
She was driving when the clinic called her back with results.
“You have abnormal cells in your cervix, and we need to schedule you for further testing.”
“What are you testing me for?”
“Cervical cancer.”
Those words rang in her head. She describes crying the entire drive home as she was digesting the possibility that she might have cervical cancer. Once she gathered herself, she realized she had so many more questions that needed to be answered.
Navigating the Unanswered Questions and Healthcare Gaps
What about the results indicated she could have cervical cancer? What were her chances of having cervical cancer? What is a colposcopy? She called her clinic back to get a better understanding but was only provided with loose explanations from a non-clinical staff person. “You do a procedure to remove a small chunk from your cervix for testing, send it off, and you will hear back 2 weeks after that.” For Lindsey, this was not enough. Without much support, she had to do her own research to fill in the gaps.
Taking matters into her own hands, Lindsey relied on Google and her sister to understand more about what was happening with her body. She learned more about the colposcopy procedure and how to interpret her abnormal results (which is a rather common finding). Being someone who believes in more action and awareness around women’s health, Lindsey tells me that she now knows that abnormal cervical cancer screening results are common, but highlights that it is a problem these issues are still not widely talked about.
Lindsey faced several barriers which delayed her colposcopy, including lapses in her health insurance and figuring out how to take time off work. While she remembers being terrified for the colposcopy, she had her father there to support her. After two weeks, Lindsey had still not heard back from the clinic about her results. Taking initiative once again, Lindsey called the clinic and learned that her results were clear. She is scheduled to have another cervical cancer screening in 6 months and may then be able to move to yearly screenings.
Built on Reliable Relationships with Providers, Teal Offers More Than An Accessible Screening
Talking about Teal Health and the Teal Wand (which Lindsey was able to use as a participant in Teal’s clinical trial), Lindsey says, “Screening would be a lot more feasible, a lot easier, not just in terms of testing but also understanding my results afterward.”
For Lindsey and many of her friends (who also work in the restaurant industry and commute long distances), having an at-home cervical cancer screening option would make the difference between staying up-to-date on their screenings or falling behind. Lindsey tells me that Teal’s at-home option, supported by telehealth, would resolve major barriers in her access to care. She would not have to figure out the travel logistics to a clinic, nor book an appointment and deal with wait times, nor take time off work to go into a clinic. Confidently, she tells me the same would be the case for her friends.
Throughout our conversation, Lindsey made it clear that she did not receive an adequate level of communication from the clinic when getting her screening and still has questions. What could have possibly caused her abnormal result? What are her next steps in preventive care? What can she do lifestyle-wise? Along these lines, she tells me that she looks forward to using Teal Health, not just because of the ease that at-home screening offers, but more so because of the consistent and reliable telehealth support from Teal’s medical providers when it comes time to understanding results and attending to follow-up care.
With Teal’s platform, Lindsey highlights that she could easily communicate with providers using virtual visits and confidential messaging. Rather than having to rely on ‘Dr. Google,’ Lindsey looks forward to building trusting relationships with providers over telehealth, where she can access steady support and receive comprehensive information around her care.
Thank you, Lindsey, for generously sharing your story. We at Teal Health are incredibly grateful to all our study participants, with a special acknowledgement for those who shared their personal stories about cervical cancer screening with us.
How HPV At-Home Self-Collection Can Help End Cervical Cancer in the United States
There is mounting evidence supporting at-home self-collected HPV tests. We know that 93% of the 12,000+ cervical cancer cases in the U.S. each year can be prevented through more accessible screening like self-collection. Other countries are on their way to eliminating cervical cancer with HPV self-collection and progress is now underway for self-collection in the US.
Australia knows, they’re already doing it
HPV Test, the Better Test
There are three main types of cervical cancer screenings: a primary HPV test (detects high-risk HPV types that can cause cervical cancer), Pap test (cervical cytology which looks for cancerous changes in cervical cells), or a co-test which conducts both the Pap and HPV test on the same sample. Since these are all screening tests, any abnormal results need to be confirmed using additional diagnostic procedures (e.g., colposcopy) or repeat HPV and/or Pap tests at recommended intervals.
High risk HPV causes 95% of cervical cancers. Based on strong evidence and recommendations supporting primary HPV tests, Teal Health runs our self-collected samples on FDA-approved HPV tests which have been extensively evaluated for cervical screening. Self-collection can detect HPV using vaginal and/or cervical cells, and is also proving to be highly accurate.
Here are a few benefits of the HPV test compared to a Pap test:
- The HPV test catches cancer earliest, which increases the chances that cervical cancer can be cured if found early enough and treated quickly.
- HPV tests are more sensitive than Pap tests and have been proven to effectively detect HPV-related precancer and cancer when it is present.
- HPV-based screening provides 60% to 70% greater protection against cervical cancer compared to the Pap test.
- People who are screened with the HPV test have a very low risk of developing HPV-related cancer (or precancer) in the years until their next routine screening.
Because Pap tests are less sensitive, they need to be conducted more frequently (every 3 years vs. 5 years for HPV) to make sure they can detect potential cancer. Compared to co-testing, primary HPV testing every 5 years can reduce a woman’s number of lifetime tests by 60% and her colposcopies by 12% with similar efficacy for cancer detection.
HPV tests also make self-collection possible, which is an important option for many people who need cervical cancer screenings but face barriers to clinic-based exams. Self-collected samples for HPV testing are proving to be as accurate as samples collected by a clinician.
Making At-Home Self-Collected Cervical Cancer Screening a Real Option in the United States
Although many other countries use self-collection for cervical cancer screening, it is new to the United States. There is mounting evidence supporting self-collected HPV tests. We know that 93% of the 12,000+ cervical cancer cases in the U.S. each year can be prevented through more accessible screening like self-collection. Importantly, many vulnerable populations, like our trans community and minority race/ethnic groups, prefer self-collection for their cervical cancer screenings.
In May 2024, the FDA approved the first two in-clinic self-collection methods for cervical cancer screening, which is tremendous news and is an important first step in eventually getting at-home self-collect approved in the US.
In April 2024, Teal Health was granted FDA Breakthrough Designation for their at-home self-collect cervical cancer screening device, the Teal WandTM. This designation will help expedite Teal Health through the FDA evaluation process, hopefully bringing at-home self-collection to the US market in the near future. An at-home method is essential in helping to increase access to this critical screening. We hope these collective efforts will push forward the US’ commitment to ending unnecessary deaths from this almost entirely preventable disease.
Other Countries Are Eliminating Cervical Cancer with HPV Self-Collection
As of 2022, 17 countries recommended self-collection for cervical cancer screening. In particular Australia – which made self-collection available to underscreened populations in 2017 and then to everyone in July 2022 – is well on its way to eliminating cervical cancer by 2035 (at least a decade before the United States).
Just one year after making self-collection widely available, Australia saw a huge (50-fold) increase in screening rates, highlighting how self-collection gives them greater control over their health, enables more comfort and privacy, and makes them more likely to stay on top of their screenings. The Netherlands saw similar increases in screening when self-collection was offered. And research is showing that people (especially vulnerable populations) are highly engaged (85-95%) in their follow-up care after HPV self-collection.
Teal envisions a future where the progress in Australia is also a reality within the United States. With a better and more convenient at-home screening experience, we know that cervical cancer can become a disease of the past.
FDA Puts Teal Health on an Accelerated Path to Market for our At-Home Cervical Cancer Screening
This is a Big Deal. Teal Health’s at-home cervical cancer screening has received FDA Breakthrough Device Designation, putting it on an accelerated path to market based on our ability to increase access to this life-saving screening.
This is a Big Deal. Teal Health’s at-home cervical cancer screening has received FDA Breakthrough Device Designation, putting it on an accelerated path to market based on our ability to increase access to this life-saving screening. This designation was given based on the strength of the interim results from our clinical trial. And, on top of that, we’ve since finished our clinical trial in record time, so when we say at-home cervical cancer screening is one step closer to becoming a reality in the US, we really mean it! This is a huge moment for women’s health, for the company, and for me who is in awe of our incredible team that is making it all happen.
A woman’s experience matters
Accelerating our time to bring at-home cervical cancer screening into the hands of women is critically important. Today, the screening is done in the office with a woman in stirrups, and the provider collecting a sample with a speculum and brush. It’s invasive. It’s uncomfortable. It’s inconvenient. And it’s causing a national health crisis. 1 in 4 women in the US are behind on their cervical cancer screenings and it doesn’t need to be like this. Teal is committed to closing the screening gap and enabling women and people with a cervix to catch up on this screening comfortably, conveniently, and privately from home. Cervical cancer is nearly entirely preventable through regular screenings; no one should be dying of cervical cancer in the US.
At Teal, one of our core beliefs and design principles is that a woman’s experience matters. Far too often healthcare overlooks the preferences and needs of women. So we’ve designed an end-to-end screening experience to increase access, by removing most barriers a woman might have. The Teal Wand allows a woman and person with a cervix to comfortably and privately self-collect their own sample, removing the barriers associated with fear, discomfort, or trauma. 97% of women in our initial study said it was very easy or easy to use. Additionally, our Telehealth platform will make care accessible and convenient addressing the barriers of time, availability, transportation, childcare, and financial burden associated with having to go into a clinic to receive care. 94% of women in our initial study said they would prefer Teal to the current standard of care.
“I believe the speed of completing our clinical trial is a testament to what happens when you design for the person and not just the detection of disease.”
People all across this country readily signed up to participate in Teal’s clinical trial because they want a better experience! We finished our study 2 months ahead of schedule and 33% larger than anticipated with over 600 participants. This is exceptional. To put it in context, 90% of studies have to double their timeline to reach their enrollment goals, of which most enroll less than 500 participants. I am so grateful to our dedicated Principal Investigators (PIs) and passionate participants, who allowed us to accomplish this. There is really something magical that happens when you design for and with women.
The FDA Breakthrough designation validates our commitment to excellence
We’ve designed the product so that women want to use it, which will increase access and adherence to screening, but at the end of the day safety and efficacy are paramount. We are trying to move a nationally recommended cancer screening into the home to increase access and save lives. This is a really big undertaking. It's important for the health of women that we reduce these barriers, but we have to make sure that the at-home collection is clinically acceptable and meets rigorous FDA requirements. Simply put, it has to work well and be easy to use by all. That is what this clinical study aims to show and the Breakthrough designation was awarded based on the strength of our results at the half-way point of the study. We’ve worked hard to ensure we meet the strict FDA standards, because this is what women deserve. We have since finished the study and are preparing for our formal submission to the FDA. We are excited to work closely with the FDA to bring this life-saving device to market as quickly as possible.
Small but mighty
Speaking of working quickly, the Teal team makes it all happen. I am in awe of this team. We are a small but forceful set of individuals who are just getting it done! The Breakthrough has been led by our clinical team, which is a powerhouse of 4 full-time individuals setting up and managing 17 sites across the country, countless analytical studies, and navigating FDA submissions and requirements. It’s unbelievable what they’ve accomplished. But this Breakthrough is also recognition of the whole solution Teal offers, which is the hard work of everyone on this team - from the physical product, to the software platform, to how we communicate and make the woman feel. It's all there, and that is everyone - and so that feels fantastic, unifying, and validating too. Teal Health is the first time I have truly had the benefit of working on something that is mission-driven. And I am learning that when you work on something that truly matters, where there is genuine passion, your capacity expands. And it expands because what you are accomplishing gives you energy. Our team is fueled by passion and that is why they are able to accomplish so much. I couldn’t feel more grateful to them all.
We are one step closer
Our next step is FDA submission and review and thanks to FDA Breakthrough Designation, we will get priority review. We can’t provide a definitive timeline of when the Teal Wand will be available, but we will be submitting our data to the FDA soon and this Designation makes it clear that self-collect cervical cancer screening is a priority to enable increased access and help close the screening gap in the US. Join our waitlist to receive updates on the Teal Wand at-home cervical cancer screening device.
Everything You Need to Know About the HPV Vaccine
The HPV vaccine protects against the 9 most common strains of HPV that can cause cancers and genital warts. We know that the HPV vaccine can prevent over 90% of HPV associated cancers. Getting vaccinated not only helps to prevent mild disease, but most importantly, the more serious diseases (HPV associated cancers like cervical cancer).
What is HPV?
HPV is the human papillomavirus. It is a common infection spread through sexual or skin to skin contact. There are many different strains of the HPV virus, which are classified as low-risk or high-risk HPV. HPV can affect different parts of the body to cause different diseases; from mild conditions such as plantar warts, to more serious conditions such as cancer.
There are about 14 types of high-risk HPV that can cause cancer of the cervix, vulva, vagina, penis, anus, mouth and throat. HPV can be asymptomatic, and our immune system can often fight to resolve the infection. However, some high-risk HPV infections can be persistent, leading to precancerous cell changes and ultimately cancer.
Cervical cancer is often caused by high-risk HPV type 16 and 18. Screening for cervical cancer in women is the best way to prevent and diagnose high-risk HPV associated cervical cancer - which accounts for nearly all cervical cancers.
Fortunately, there is also a vaccine!
What is the HPV vaccine?
The HPV vaccine used in the United States is called Gardasil 9 ®, which protects against the 9 most common strains of HPV that can cause cancers and genital warts.
Why should I get vaccinated?
HPV is common and easily spread. Our immune system is usually able to fight this infection, but sometimes it can’t, leading to more serious disease. In the United States, it’s estimated that HPV causes over 37,000 new cases of cancer per year. We know that the HPV vaccine can prevent over 90% of HPV associated cancers. Getting vaccinated not only helps to prevent mild disease, but most importantly, the more serious diseases (HPV associated cancers).
How does the HPV vaccine work?
Like most vaccines, it contains a small component of the HPV virus. When administered, it helps to produce an immune response to the HPV virus. Our immune system stores this response in case it needs to remember it in the future to help fight an HPV infection. The vaccine does not cause an HPV infection.
Who is eligible for the vaccine?
The HPV vaccine is recommended for adolescents (girls and boys) starting at age 9-12 and can be given up until the age of 26. The vaccine is administered at a young age to help the body build a defense prior to any exposure of HPV. It is given as a 2 or 3 dose vaccination series depending on the starting age of vaccination.
Some adults, ages 27 to 45, can also receive the vaccination. The eligibility for the vaccine in this age group can vary from person to person based on risk (i.e. individuals with multiple sex partners, immunocompromised individuals are at higher risk of getting HPV), so it’s important to talk to your healthcare provider to assess your personal health profile.
A 2-dose vaccination series is given to people who get the first vaccine dose before age 15 (0, 6-12 month schedule). A 3-dose vaccination series is given to people who get the first vaccine dose at age 15-45 (0, 1-2, 6 month schedule). If a vaccine dose is missed, previous vaccine doses do not need to be repeated and your provider can help with catch-up vaccine doses.
Is the vaccine safe?
Yes! The HPV vaccine went through vigorous safety testing before it was approved by the FDA (U.S. Food and Drug Administration) in 2006. It has been in use for over 15 years, and its safety and effectiveness continues to be proven through close monitoring by the CDC (Center for Disease Control and Prevention) and FDA.
Will I have any side effects from the vaccine?
You can have mild side effects from the HPV vaccine (similar to other vaccines) such as a fever, headache, dizziness, nausea or muscle ache. You may also develop redness, soreness or swelling at the site where the vaccine was given to you. These symptoms usually resolve within 24-48 hours after the vaccine.
It is important to notify your provider if you have any severe or life-threatening allergies or had a previous allergic reaction to the HPV vaccine. The HPV vaccine is not recommended during pregnancy.
Do I still need to get screened for cervical cancer if I get the HPV vaccine?
Yes! It is still important to continue screening for cervical cancer even if you have received the HPV vaccine. While the HPV vaccine protects against some of the most common strains of HPV that can cause cervical cancer, it does not protect against all.
Learn more about Teal Health’s self-collect cervical cancer screening device, the Teal Wand, currently in clinical trials in the U.S. for FDA submission.
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