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First at-home HPV test approved by FDA, could replace Pap smear

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First at-home HPV test approved by FDA, could replace Pap smear

The Food and Drug Administration (FDA) has approved the first at-home screening test for cervical cancer, the product’s maker announced on Friday.

The DIY test could serve as an alternative to in-person “Pap smears,” which are recommended every three years for women up to age 65.

The self-collection device — the Teal Wand, made by Teal Health in San Francisco — allows women to procure a sample and mail it in for laboratory analysis.

NEW CERVICAL CANCER TREATMENT APPROACH COULD REDUCE RISK OF DEATH BY 40%, TRIAL RESULTS SHOW

The test is designed to detect human papillomavirus (HPV), the virus that causes almost all cervical cancer cases.

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The Food and Drug Administration has approved the first at-home screening test for cervical cancer, the product’s maker announced on Friday. (iStock)

The approval comes after a clinical trial including more than 600 women, in which the Teal Wand had a 96% accuracy rate of detecting cervical precancers.

In the study, 86% of participants said they’d be more likely to comply with cervical cancer screening recommendations if they could do it at home, Teal Health reported.

Additionally, 94% said they would prefer to self-collect at home as long as the results were accurate.

CERVICAL CANCER DEATHS COULD BE REDUCED WITH HOME HPV TESTING, STUDY FINDS

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“Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward,” said Dr. Christine Conageski, associate professor, OB-GYN and director of the Complex Dysplasia Clinic at the University of Colorado, who was a principal investigator in the SELF-CERV trial. 

“It offers an evidence-based way to expand access without compromising accuracy,” she added in a statement.

Woman at OB-GYN

“Cervical cancer is largely preventable, yet screening rates in the U.S. continue to lag, and the FDA approval of this at-home Teal Wand self-collection device is a critical step forward,” a doctor said. (iStock)

Approximately 11,500 new cervical cancer diagnoses are made in the U.S. each year, and the disease causes 4,000 annual deaths, according to the Centers for Disease Control and Prevention. 

In addition to the cervical cancer risk, some higher-risk incidences of HPV can also cause other types of cancers, according to experts.

“Any type of test that helps detect cervical cancer is a win.”

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Women between the ages of 25 and 65 who are at average risk of cervical cancer will soon be able to order the at-home test at www.getteal.com, according to the company’s announcement.

Kits are expected to first become available in California starting in June, with plans to expand across the country “as soon as possible,” the company said in its announcement.

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“Teal is working with major insurance providers and plans to have flexible payment options, helping to remove financial concerns and ensuring more women have access to this preferred at-home screening if they want it,” the company stated. 

doctor holds teal and white ribbon for Cervical Cancer awareness

Approximately 11,500 new cervical cancer diagnoses are made in the U.S. each year, and the disease causes 4,000 annual deaths. (iStock)

In addition to the collection kit, the product also includes a telehealth service with support from medical providers throughout the process.

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Women who test positive for HPV will be referred for a traditional Pap smear. Those who do not test positive are not considered at risk of cervical cancer and will not need to screen again for three to five years.

“Some women are scared of a traditional Pap smear or find the process uncomfortable — as a result, they put off this vital test,” said Ami Vaidya M.D., co-chief of gynecologic oncology at Hackensack University Medical Center’s John Theurer Cancer Center, in a press release. (She was not involved in the trial.)

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“This could be an important tool in getting more women regularly screened, especially those who don’t have access to a medical provider. Any type of test that helps detect cervical cancer is a win.”

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Trump’s Focus on Punishing Drug Dealers May Hurt Drug Users Trying to Quit

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Trump’s Focus on Punishing Drug Dealers May Hurt Drug Users Trying to Quit

President Trump has long railed against drug traffickers. He has said they should be given the death penalty “for their heinous acts.” On the first day of his second term, he signed an executive order listing cartels as “terrorist organizations.”

But many public health and addiction experts fear that his budget proposals and other actions effectively punish people who use drugs and struggle with addiction.

The Trump administration has vowed to reduce overdose deaths, one of the country’s deadliest public health crises, by emphasizing law enforcement, border patrols and tariffs against China and Mexico to keep out fentanyl and other dangerous drugs. But it is also seeking huge cuts to programs that reduce drug demand.

The budget it submitted to Congress this month seeks to eliminate more than a billion dollars for national and regional treatment and prevention services. The primary federal agency addressing drug use, the Substance Abuse and Mental Health Services Administration, has so far lost about half its workers to layoffs under the Trump administration and is slated to be collapsed into the new Administration for a Healthy America, whose purview will reach far beyond mental illness and drug use.

And if reductions to Medicaid being discussed by Republicans in Congress are realized, millions of Americans will be unable to continue, much less start treatment.

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The White House did not respond to requests for comment. The budget itself says that ending drug trafficking “starts with secure borders and a commitment to law and order” and that it is cutting addiction services deemed duplicative or “too small to have a national impact.”

Those cuts are agonizing, public health experts say, because they come just as the country is making sustained progress in lowering the number of fentanyl deaths. Many interventions may be contributing to that progress, including greater availability of the overdose reversal spray naloxone; more treatment beds, sober housing and peer counseling; and declines in the strength and quantity of the illicit drug supply, they say. But studies so far have not demonstrated convincingly which of those factors merit greater focus and investment.

“It would be a tragedy if we defund these programs without fully understanding what’s working and then our overdose rate starts to climb again,” said Dr. Matthew Christiansen, an addiction medicine physician in Huntington, W.Va., a city once labeled ground zero for the opioid crisis.

A letter signed by more than 320 behavioral medicine academic experts, sent Monday to congressional leaders, decried the cuts, including those to “community-based naloxone distribution, peer outreach programs, drug-use-related infectious disease prevention programs and drug test strip programs.”

The president’s budget calls for ending grants for “harm reduction,” a strategy to prevent disease transmission and keep drug users alive that has become largely accepted by mainstream addiction treatment providers.

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The budget derides federal financial support for “dangerous activities billed as ‘harm reduction,’ which included funding ‘safe smoking kits and supplies’ and ‘syringes’ for drug users.”

That language is a callback to false reports in 2022 that a $30 million federal harm reduction grant could be used to purchase pipes for smoking crack and meth. In fact, a small portion of that grant, designated for “safer smoking kits,” was for supplies like alcohol swabs and lip balm. The grant also supported programs in states that permit sterile syringe exchanges, effective in reducing hepatitis C and H.I.V. infection rates.

“You can’t just tell people to stop using drugs with a snap of the fingers,” said Dr. Christiansen, a former director of West Virginia’s drug control policy. “These are tools to reduce the harm of opioids while also helping them be successful long-term.”

According to the federal agency’s annual survey of substance use, in 2023, 27.2 million Americans ages 12 or older had a drug use disorder, 28.9 million had alcohol use disorder, and 7.5 million had both.

The budget does leave intact block grants for states to combat addiction and mental illness. But without the agency’s additional grants, hands-on training and monitoring, in addition to possible Medicaid reductions, states will not be able to afford the many medical and social services required to prevent and treat addiction, Dr. Christiansen said.

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David Herzberg, a professor of drug policy and history at the University at Buffalo, said that Mr. Trump’s almost single-minded linking of the nation’s drug problems with border issues harks back to late 19th-century America, when the government associated opium dens with Chinese immigrants. Fearing the incursion of Chinese workers and inflamed by press reports of Chinese men using opium to lure young white women into prostitution, Congress severely restricted Chinese immigration.

Then as now, Mr. Herzberg said, political conservatives found that targeting foreign drug suppliers was a muscular means of advancing broader agendas.

In contrast with highly publicized drug seizures, people who chronically use drugs have become afterthoughts, usually visible only as street irritants, their addiction perceived to be the result of their own choices, he said. Elected leaders who advocate for their welfare risk being tarred as soft on crime.

“If politicians are going to stick their necks out for them, I would be shocked,” Mr. Herzberg said.

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FDA warns seniors to avoid this vaccine after deadly complications

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FDA warns seniors to avoid this vaccine after deadly complications

Older adults are being warned against receiving the chikungunya vaccine before traveling.

The Ixchiq vaccination, developed by Valneva to prevent the mosquito-borne chikungunya virus, was approved by the Food and Drug Administration (FDA) in November 2023 as the first of its kind.

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The approval applies to anyone aged 18 and older who has a risk of being exposed to the virus.

FIRST VACCINE FOR CHIKUNGUNYA VIRUS, AN ‘EMERGING GLOBAL HEALTH THREAT,’ GETS FDA APPROVAL

But the FDA and the Centers for Disease Control and Prevention (CDC) released a safety notice on May 9 recommending that adults over 60 years old pause use of the vaccine due to fatal complications.

“FDA and CDC will continue the evaluation of post-marketing safety reports for Ixchiq,” the release reads. 

Older adults are being warned against receiving the chikungunya vaccine before traveling. (iStock)

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“While the safety of Ixchiq for use in individuals 60 years of age and older is being further assessed, FDA and CDC are recommending a pause in use of the vaccine in this age group. FDA and CDC will update the public when the agencies complete their evaluation of this safety issue.”

The advisory follows reports of “serious adverse events,” including neurologic and cardiac events in people who received the vaccine.

    

Two of 17 events resulted in death from severe complications. One death was caused by encephalitis, or inflammation in the brain, the alert stated.

Those who experienced adverse effects of the vaccine were reported to be between the ages of 62 and 89.

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A patient infected with chikungunya

A patient infected with chikungunya looks out from mosquito netting at the Clinicas Hospital in San Lorenzo, Paraguay, in March 2023. The FDA warned that Ixchiq, which contains a live, weakened version of the virus, may cause similar symptoms to chikungunya. (AP Photo/Jorge Saenz)

The FDA warned that Ixchiq, which contains a live, weakened version of chikungunya, may cause symptoms similar to the virus.

Typical symptoms of chikungunya include fever, severe joint pain, headache, muscle pain and a rash, according to the CDC. 

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Most people recover within a week, but some may experience “severe and disabling” joint pain for weeks or months. 

mosquito sucking blood from human

Chikungunya is spread by the bite of infected mosquitoes. (iStock)

“This virus is in a similar category as dengue or Zika and is carried by the same mosquitoes,” Fox News senior medical analyst Dr. Marc Siegel previously told Fox News Digital.

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At the time of the vaccine’s approval, the FDA described chikungunya as an “emerging global health threat,” with at least five million cases reported over the past 15 years. 

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The FDA plans to conduct an “updated benefit-risk assessment” for Ixchiq use in those over 60 years of age, according to the notice.

Fox News Digital’s Melissa Rudy contributed to this report.

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Lose Weight up to 8x Faster With a ‘Green’ Diet for Fatty Liver

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Lose Weight up to 8x Faster With a ‘Green’ Diet for Fatty Liver


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Diet for Fatty Liver: How to Lose Weight Faster and Easier | Woman’s World




















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