First at-home test kit for cervical cancer approved by the FDA, company says
Updated: 5:45 PM CDT May 9, 2025
First at-home test kit for cervical cancer approved by the FDA, company says
Updated: 5:45 PM CDT May 9, 2025
SO JANUARY IS CERVICAL CANCER AWARENESS MONTH. IT鈥橲 A TIME TO RAISE AWARENESS ABOUT THE CANCER. HOW TO PREVENT IT. EARLY DETECTION AND TREATMENT OPTIONS. JOINING US LIVE IS NURSE PRACTITIONER NICOLE DREIBELBIS FROM UPMC GYNECOLOGY ONCOLOGY. THANK YOU SO MUCH FOR JOINING US NICOLE. REALLY APPRECIATE IT. THANKS FOR HAVING ME. SO FOR PEOPLE WHO AREN鈥橳 FAMILIAR, WHAT IS CERVICAL CANCER. SO CERVICAL CANCER IS CANCER OF THE LOWER PART OF THE UTERUS OR THE WOMB. THERE ARE ACTUALLY TWO DIFFERENT ORGANS, BUT WE OFTEN REFER TO THEM AS THE SAME THING. HOW DOES SOMEONE GET CERVICAL CANCER? SO MORE THAN 99% OF CERVICAL CANCERS ARE FROM HPV OR HUMAN PAPILLOMAVIRUS, WHICH IS A SEXUALLY TRANSMITTED INFECTION. AND THE CDC SAYS IT鈥橲 ESTIMATED ABOUT 11,500 WOMEN ARE DIAGNOSED EVERY YEAR WITH CERVICAL CANCER. NOW IN PENNSYLVANIA, NEARLY 500 WOMEN ARE DIAGNOSED WITH IT EACH YEAR. WHAT ARE SOME OF THE SIGNS AND SYMPTOMS WOMEN SHOULD BE AWARE OF? WELL, UNFORTUNATELY, EARLY STAGE CERVICAL CANCER WHEN IT FIRST PRESENTS IS OFTEN ASYMPTOMATIC OR DOESN鈥橳 HAVE SYMPTOMS. SO THAT鈥橲 WHY IT鈥橲 SO IMPORTANT FOR PATIENTS TO CONTINUE WITH THEIR GYNECOLOGIC CARE, THEIR ROUTINE SCREENINGS FOR THEIR PAP SMEARS IN ORDER TO DETECT HUMAN PAPILLOMAVIRUS OR CHANGES TO THEIR CERVIX EARLY. AND DO YOU TEND TO SEE WOMEN WITH CERVICAL CANCER WITHIN A CERTAIN AGE GROUP? IS IT A YOUNGER AGE GROUP? I THE MOST COMMON AGE IS BETWEEN AGES LIKE 35 AND 50, BECAUSE THEY鈥橰E WOMEN WHO OFTENTIMES ARE MAYBE NO LONGER HAVING PREGNANCIES. SO THEY STOP GOING TO THE OB GYN. THEY鈥橰E BUSY TAKING CARE OF THEIR GROWING FAMILY, FAMILIES OR, YOU KNOW, KICKING -- IN THEIR CAREERS. AND THEY FEEL FINE. SO THEY DON鈥橳 NECESSARILY THINK ABOUT THEIR CERVIX. AND OFTENTIMES, YOU KNOW, THEY START HAVING BLEEDING OR PAIN AND THEN GO GET EVALUATED. AND IT鈥橲 ALREADY DIAGNOSED. YEAH. AND THAT鈥橲 WHY WE鈥橰E TALKING ABOUT IT. RIGHT. SO HOW DO BETTER SCREENING METHODS LIKE HPV DNA TESTING AND EASIER ACCESS TO PAP SMEARS HELP IN EARLY DETECTION AND TREATMENT OF CERVICAL CANCER? THEY鈥橰E HUGE. THE HPV VACCINE THAT IS IN EXISTENCE NOW, THAT COVERS NINE OF THE STRAINS IS WONDERFUL. IT SHOULD IT CAN BE GIVEN TO KIDS AGE 11 TO 12, BOYS OR GIRLS, AND UP TO AGE 26 AFTER THAT. IT鈥橲 A DECISION YOU MAKE WITH YOUR CLINICIAN BECAUSE IT鈥橲 NOT ROUTINELY RECOMMENDED. BUT THE HPV VACCINE HAS DRASTICALLY IMPACTED IN A GOOD WAY. OUR PRECANCEROUS AND OUR CANCERS. THE OTHER WAY IS BY GOING TO GET YOUR PAP SMEARS EVERY 3 TO 5 YEARS, DEPENDING ON YOUR RISK FACTORS, WHICH YOUR CLINICIAN WILL GO OVER WITH YOU, AND MAKE SURE THAT YOU鈥橰E JUST IN TUNE WITH YOUR BODY AND ANY ABNORMAL BLEEDING. GET IT CHECKED OUT. AND I UNDERSTAND THIS VACCINE鈥橲 BEEN OUT SINCE 2006. HAVE YOU GUYS SEEN A SIGNIFICANT DECLINE IN HPV IN CERVICAL CANCER, OR IS IT TOO EARLY TO TELL? NO, WE DEFINITELY HAVE. WE鈥橵E SEEN, I THINK THE STATISTICS SAY 88% DROP IN TEEN GIRLS IN GENITAL WARTS AND HPV RELATED CANCERS, AND 81% AMONG YOUNG ADULT WOMEN. AND THAT鈥橲 JUST FROM THE VACCINE. YES. OH, WOW. THAT鈥橲 FASCINATING. SO WHAT DOES THE CDC RECOMMEND FOR HPV VACCINATION AND WHY IS IT IMPORTANT TO VACCINATE YOUNG PEOPLE? LIKE YOU鈥橰E SAYING YOU鈥橰E ALREADY SEEING THE RESULTS. YEAH. SO IF WE CAN VACCINATE THEM BEFORE THEY ARE EXPOSED TO THE HPV VIRUS, WE CAN ALLOW THEIR BODIES TO CREATE AN IMMUNE RESPONSE SO THAT IF THEY ARE EXPOSED AT SOME POINT, THEIR BODY鈥橲 ALREADY PREPARED AND CAN FIGHT THE VIRUS TO ALLOW IT TO GO AWAY, INSTEAD OF SET UP SHOP AND CAUSE CHANGES. AND AFTER SOMEONE HAS CANCER. CAN YOU TALK ABOUT THE TREATMENTS THAT ARE OUT THERE TODAY? YEAH, ABSOLUTELY. SO IF IT IS AN EARLY STAGE CANCER, WE CAN OFTEN JUST DO SURGERY TO REMOVE THE CANCEROUS PORTION, POTENTIALLY PERFORM A HYSTERECTOMY WHERE THE CERVIX AND THE UTERUS PLUS OR MINUS OTHER ORGANS ARE ALSO REMOVED. IF IT IS A SLIGHTLY ADVANCED STAGE. WE DO HAVE CHEMOTHERAPY. MORE RECENTLY WE HAVE IMMUNOTHERAPIES THAT HAVE BEEN HELPFUL. AND THEN OF COURSE THERE鈥橲 RADIATION WHICH TENDS TO BE VERY EFFECTIVE WITH CERVICAL CANCER PATIENTS AS WELL. IS THERE ANYTHING ELSE THAT YOU鈥橠 LIKE WOMEN TO KNOW. WOMEN AND YOUNG GIRLS TO KNOW ABOUT THIS? ANYBODY WITH A CERVIX? IF YOU HAVEN鈥橳 GOTTEN A VACCINE, IT鈥橲 A GREAT TIME TO GO DO IT. IT鈥橲 ALSO REALLY IMPORTANT. YOU KNOW, I THINK A LOT OF PARENTS ESPECIALLY, AND I AM ONE WHEN THEY TALK ABOUT A VACCINE FOR YOUR CHILD AT AGE 11 OR 12 AND THEY鈥橰E TALKING ABOUT IT BEING SOMETHING SEXUALLY TRANSMITTED, THAT鈥橲 THE LAST THING YOU鈥橰E THINKING ABOUT FOR YOUR CHILD AT THAT AGE. BUT TRULY PROTECTING THEM PRIOR TO THEIR EXPOSURE IS WHAT鈥橲 IMPORTANT. BECAUSE EVEN IF THEY ONLY EVER HAVE ONE OTHER INTIMATE PARTNER, ONE TOTAL INTIMATE PARTNER IN THEIR LIFE, IF THAT PERSON HAS EVER BEEN INTIMATE WITH SOMEBODY ELSE, YOUR CHILD WILL BE AT RISK AS WELL. SO GETTING AHEAD OF IT IS IS WONDERFUL. IT鈥橲 THE BEST THING YOU COULD DO FOR YOUR CHILD. AND ALSO JUST GO FOR SCREENINGS. ALL RIGHT, NICOLE, THANK YOU SO MUCH FOR YOUR INSIGHT A
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First at-home test kit for cervical cancer approved by the FDA, company says
Updated: 5:45 PM CDT May 9, 2025
U.S. regulators have approved the first cervical cancer testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company.Teal Health said Friday the Food and Drug Administration approved its Teal Wand for home use, offering a new way to collect vaginal samples that can detect the HPV virus that causes cervical cancer. Currently, HPV tests and Pap smears are performed at a health clinic or doctor's office.An influential federal panel recommended last year the use of self-collection of HPV samples to boost screening. The FDA also recently expanded the use of two older HPV tests for self-collection, but those must be done at a medical office or mobile clinic.HPV, or human papillomavirus, is very common and is spread through sex. Most HPV infections clear up on their own, but persistent infection can lead to cancer of the cervix. Most cervical cancers occur in women who are inadequately screened, diagnosed or treated.To collect a sample, a swab or brush is inserted into the vagina and rotated, then the swab is put into a tube or container and processed at a lab.Teal Health's kit requires a prescription, which customers can obtain through one of the company's online health providers. The San Francisco-based company said it will initially beginning selling the kits in California next month before expanding to other states. The company also said it is working with insurers on health coverage for the test.
WASHINGTON —
U.S. regulators have approved the first cervical cancer testing kit that allows women to collect their own sample at home before shipping it to a laboratory, according to a medical device company.
Teal Health said Friday the Food and Drug Administration approved its Teal Wand for home use, offering a new way to collect vaginal samples that can detect the HPV virus that causes cervical cancer. Currently, HPV tests and Pap smears are performed at a health clinic or doctor's office.
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An influential federal panel recommended last year the use of self-collection of HPV samples to boost screening. The FDA also recently expanded the use of two older HPV tests for self-collection, but those must be done at a medical office or mobile clinic.
HPV, or human papillomavirus, is very common and is spread through sex. Most HPV infections clear up on their own, but persistent infection can lead to cancer of the cervix. Most cervical cancers occur in women who are inadequately screened, diagnosed or treated.
To collect a sample, a swab or brush is inserted into the vagina and rotated, then the swab is put into a tube or container and processed at a lab.
Teal Health's kit requires a prescription, which customers can obtain through one of the company's online health providers. The San Francisco-based company said it will initially beginning selling the kits in California next month before expanding to other states. The company also said it is working with insurers on health coverage for the test.
