FDA authorizes 1st over-the-counter combo flu and COVID test outside of emergency use
(WASHINGTON) — The U.S. Food and Drug Administration authorized the first over-the-counter combination COVID-19 and flu test outside of emergency use on Monday evening.
This means the Healgen Rapid Check COVID-19/Flu A&B Antigen Test is available without a prescription. The FDA said the test is for those who are experiencing respiratory symptoms.
While there are other over-the-counter combination tests currently available, this is the first to be marketed to consumers using the traditional approval pathway outside of a public health emergency.
The new combination test uses a nasal swab sample to deliver at-home results for COVID-19 and influenza in approximately 15 minutes.
Healgen’s test detects proteins from both SARS-CoV-2, which is the virus that causes COVID-19, and influenza A and B, which are the viruses that cause flu.
“As we enter this year’s annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a statement. “Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”
“The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions,” the statement continued.
The test is for use by people 14 and older who can take their own sample, or those 2 and older, who have a sample taken by an adult, according to the federal health agency.
Data reviewed by the FDA found the test correctly identified 99% of negative and 92% of positive COVID samples. Additionally, the test correctly identified 99.9% of negative flu samples, and 92.5% and 90.5% of positive flu samples, respectively.
Like other over-the-counter COVID-19 antigen tests, the FDA says a positive test result likely means a patient is positive while a negative rest result may require a confirmation test.
However, people who test negative and continue to experience symptoms including cough, fever and shortness of breath should follow up with their health care provider, the FDA says. Similarity, the FDA says those who test positive should take appropriate precautions to avoid spreading either virus and should also follow up with their health care provider.
(NEW YORK) — A woman who lost over 200 pounds said she accomplished it by focusing not on the weight she was losing, but the life she was gaining.
“I wanted to gain life more than I wanted to lose weight,” Leah Hope told ABC News’ Good Morning America of her motivation, adding, “There’s a much bigger picture that this is not about wanting a smaller body, but it is about chasing a bigger life.”
Hope, 35, said she hit a “rock bottom” moment in 2022 when she visited Disneyland in California with family members.
Weighing almost 400 pounds at the time, Hope said she remembers being in pain after just a few hours of walking at the theme park.
“I just had to end up spending most of the day by myself while my sister’s family was out enjoying the park,” Hope recalled. “I just left that day saying, ‘This is not the life that I want to be living, and if I continue on the path that I’m on, this is what my life is going to continue to look like.'”
After being overweight most of her life, Hope said she realized she had “become comfortable in my discomfort” and was motivated to change things.
She said she started small and focused on making one change at a time and then layering on more changes.
“Once that thing didn’t feel overwhelming anymore, then I added another thing,” Hope said.
For example, Hope said she started her weight loss journey by just adding one nutritious food to her diet each day.
Once she was comfortable with that change, she added one nutritious meal, and then began walking 10 minutes per day and later began writing what she was eating in a food journal.
“What prompted me to try to lose weight naturally was my focus on wanting to get healthy from the inside out, both internally, hormones, organs, all that, and mentally, emotionally, just holistic health, changing my lifestyle overall,” Hope said. “And so it seemed like it would make most sense to approach this naturally for myself.”
Hope added that while small changes and a natural approach to weight loss worked for her, everyone is different. People should consult with their health care provider before starting any weight loss routine.
“I strongly believe everyone has to decide what the best route is for them,” Hope said.
As she started to change her lifestyle, Hope began sharing her journey on social media. A TikTok video she posted last year, one year into her weight loss effort, now has over 14 million views.
When she faced obstacles on her two-year weight loss journey, Hope said she reminded herself of her focus on “gaining life” versus losing weight.
“As long as I continued to tell myself that, I could look at the scale and say, ‘You know what? Maybe the scale didn’t go down this week, but I did 2,000 more steps this day,’ or, ‘I actually enjoyed this healthy meal that I prepared,” Hope said. “Shifting my mindset to focus on building healthy habits, rather than just seeing a smaller number on the scale, is really what helped me continue through the road bumps, through not seeing the results that I wanted, and just continuing to remind myself that there’s a much bigger picture to this.”
The Walt Disney Co., is the parent company of ABC News.
(NEW YORK) — Sara Anne Willette has spent more than 1,620 days in isolation since the start of the COVID-19 pandemic.
The New Jersey resident took health precautions in public before the pandemic because of her common variable immunodeficiency, which means she doesn’t make enough antibodies to fight infections.
Simple tasks like going for a walk down the street or taking a trip to the grocery store are laden with safety hurdles and anxiety for Willette.
Stressful tasks, like moving from Iowa to New Jersey during the pandemic for her husband’s new job, are now even more taxing. The two drove overnight to avoid crowds at gas stations and rest stops, and she’s prepared to do it again. The substantial health precautions in her day-to-day life are forcing her and her family to pack up their life once more and look for a new home in the countryside.
“I’m angry that society is largely inaccessible and I have to risk my life for the bare minimum, like medical care,” Willette told ABC News in a phone call. “Why live in civilization if all of it is completely inaccessible?”
More than four years after the start of the COVID-19 pandemic, Willette is among the immunocompromised and disabled Americans who’ve complete changed their way of living to survive.
Her anger was tinged with disappointment as she talked about how the rest of the world has gone back to normal despite the hundreds of people across the country dying from COVID-19 each week amid a summer surge of the virus.
COVID-19 has also been a debilitating event for tens of millions of people who have or are currently experiencing long COVID, which in some cases has been defined as a disability under the Americans with Disabilities Act.
With some lawmakers beginning to propose mask bans in hopes of reducing crime, it’s no longer an option for some to live life normally among the rest of society.
Willette was among the people ABC News checked back in with after previously talking to them about isolating two years after the pandemic began.
Finding a new normal
There are simple joys that Willette misses: having a garden, running, walking, letting her dogs run without a leash and drinking coffee on a porch.
She’s planning on moving to the mountains — somewhere between New Hampshire and Virginia — and gaining enough acreage to allow her and her family to embrace the activities they lost during the pandemic. However, being alone out in the countryside isn’t the goal for Willette.
Rather, she intends to build a pathogen-aware community. That means buying enough land so other disabled, immunocompromised or health-conscious able-bodied people who don’t want to get COVID-19 can join them and create a home of their own.
“We want something that feels like normal but is set up in a way that we decrease harm for everyone in the community,” Willette said. “We can’t do that in an urban area or even in a suburban area. There are too many risks.”
Her mother and mother-in-law intend to move and join Willette, her husband and her son on the property as well.
For Charis Hill, a California resident who has a systemic inflammatory disease and takes immunosuppressive medications, it’s been hard to access an in-person doctor’s appointment since many safety precautions for COVID-19 are no longer being taken in medical care facilities.
As someone with “high-level medical needs,” the lack of COVID precautions has even made seeking routine care a challenge.
“Just the fact that a medical environment that is supposed to know what a virus can do, most medical environments no longer require masking, and that’s what makes it unsafe for people like me to go, for anybody to go,” Hill told ABC over the phone.
“The impact of the delayed care, where people can’t go get routine care, that’s going to affect the whole health care system. Emergencies happen because of delayed care.”
Despite the stress and forced isolation, they find moments of joy growing their own food in their garden, and stay busy by working to reduce the local feral cat population through Trap-Neuter-Return practices.
They break their isolation monthly to meet at a park with a close-knit circle of friends who take similar safety precautions — they’re all masked, socially distanced and have tested beforehand.
“That’s really the only way for me to meet strangers and also to make new friends,” Hill said.
Mask bans would further bar immunocompromised people from public life, according to Hill.
Such bans “make it unsafe for us to exist,” Hill noted, because people may feel pressure not to wear masks when they’re sick or if immunocompromised people are worried about backlash for doing so.
With more people testing positive for COVID this summer, and with the fall and winter virus season ahead, Hill says society’s “new normal” should involve free testing, vaccines, access to at-home antiviral therapy paxlovid and flexible hybrid working options to mitigate the spread of illnesses.
“We need a new normal, and a new normal that is equitable for everyone, and that not only prioritizes high risk people, but that also reduces infection overall,” Hill said.
COVID concerns for the immunocompromised population
Immunocompromised people — about 3% of the adult population in the U.S., according to the National Institutes of Health — continue to face potentially serious medical complications or death when it comes to COVID-19. Even for those who were not previously at risk now have seen life-changing heath impacts.
“Long COVID can happen to anyone, and I have certainly seen young, healthy, vigorous athletes have prolonged, debilitating symptoms from long COVID,” Dr. Jeannina Smith, the medical director of University of Wisconsin’s Transplant Infectious Disease Program, told ABC over the phone.
However, society has largely appeared to have moved on. The CDC stopped recording some COVID-19 related data and some politicians have proposed mask bans as a potential solution to crime.
“It takes us a step back for public health,” Hill said. “We have other pandemics that are coming, and it’s going to make it harder to reenact mask mandates if we need them in the future.”
For the immunocompromised, regular society could seem like a minefield, according to Dr. Cassandra M. Pierre, the medical director of Public Health Programs and the associate hospital epidemiologist at Boston Medical Center.
She noted that people at higher risk for complications “are still, unfortunately, in our hospitals today. We see that they have this forced risk of going on to develop critical COVID or potentially even die. This is still occurring. COVID is still happening.”
This is all happening despite a better understanding of disease transmission and the information needed to be better equipped to empower communities to protect their health, Pierre added.
Patients have been harassed or mocked for wearing masks in public, Dr. Jeannina Smith noted, despite international and national medical organizations emphasizing the importance of mask wearing as a mitigation tactic for illnesses. Hill has experienced this first hand.
“You can’t look at someone and know that they’re receiving immunosuppression for an organ transplant or an autoimmune condition, and they remain at risk,” Smith said.
“Even if you don’t have individual risk, any person can still spread COVID to someone who has higher risk,” she said. “In fact, much of the spread continues to be from asymptomatic person. The very idea that we would criminalize wanting to protect our fellow citizens is pretty horrific.”
The federal government has recently changed its tune amid the summer COVID spike and is preparing for the upcoming fall and winter season by approving and granting emergency use authorization for updated COVID-19 vaccines and restarting its free at-home COVID tests program.
(SILVER SPRING, Md.) — The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years.
Cobenfy, manufactured by Bristol Myers Squibb, combines two drugs, xanomeline and trospium chloride, and is taken as a twice-daily pill. In clinical trials, this combination helped manage symptoms such as hallucinations, delusions, and disorganized thinking, which are common in schizophrenia.
“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the approval announcement.
“This drug takes the first new approach to schizophrenia treatment in decades,” Farchione continued. “This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
Cobenfy offers new hope for people with schizophrenia, providing an innovative treatment option that could change how this condition is managed, according to Jelena Kunovac, MD, a board-certified psychiatrist and adjunct assistant professor at the University of Nevada, Las Vegas, in the Department of Psychiatry.
“We are overdue for a medication that targets schizophrenia with a different mechanism of action,” Kunovac told ABC News.
The first drugs for schizophrenia, including chlorpromazine and haloperidol – also known by the brand names Thorazine and Haldol, respectively – were introduced in the 1950s and revolutionized treatment of the disease. However, there have been very few new medications since then, with most subsequent FDA approvals being for variations of these older drugs.
Most schizophrenia medications, broadly known as antipsychotics, work by changing dopamine levels, a brain chemical that affects mood, motivation, and thinking, Kunovac explained. Cobenfy takes a different approach by adjusting acetylcholine, another brain chemical that aids memory, learning and attention, she said.
By focusing on acetylcholine instead of dopamine, Cobenfy may reduce schizophrenia symptoms while avoiding common side effects like weight gain, drowsiness and movement disorders, clinical trials suggest. These side effects often become so severe and unpleasant that, in some studies mirroring real-world challenges, many patients stopped treatment within 18 months of starting it.
In clinical trials, only 6% of patients stopped taking Cobenfy due to side effects, noted Dr. Samit Hirawat, chief medical officer at Bristol Myers Squibb. “That’s a significant improvement over the 20-30% seen with older antipsychotic drugs,” he added.
The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, increased heart rate, dizziness and gastroesophageal reflux disease, according to the FDA announcement.
“It may prove advantageous to those who don’t tolerate what has been available,” Dr. Leslie Citrome, a clinical professor of psychiatry and expert in psychopharmacology at New York Medical College, told ABC News regarding Cobenfy. “This will provide a new approach that may work out quite nicely.”
Citrome emphasized that patients who have trouble tolerating the side effects of traditional schizophrenia medications may benefit most from Cobenfy, and that a different mechanism of action holds hope for those who have not responded adequately to existing treatments.
Schizophrenia is a mental health disorder that affects about 24 million people worldwide, or roughly one in 300 people, according to the World Health Organization (WHO). It often leads to significant challenges in daily functioning, work, and relationships, impacting both patients and their families.
The disorder typically begins in late adolescence or early adulthood and can lead to lifelong disability if not properly managed, according to the WHO, further highlighting the need for effective treatment options.
Following approval, doctors could start prescribing Cobenfy by the end of October, according to Adam Lenkowsky, executive vice president and chief commercialization officer at Bristol Myers Squibb.
Experts hope that the drug’s unique mechanism and reduced side effects will help set a new standard of care for schizophrenia patients. Studies for additional therapeutic uses, including the treatment of Alzheimer’s disease and bipolar disorder, are also underway.
Jake Goodman, MD, MBA is a psychiatry resident physician and a member of the ABC News Medical Unit.