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The number of cases in the E. coli outbreak linked to McDonald’s Quarter Pounders has risen to 90, federal health officials said in an update on Wednesday.
Cases have been reported in 13 states, according to the Centers for Disease Control and Prevention (CDC).
Most of the cases have been in Colorado, which has 29 reported cases, and Montana, which has 17 reported cases, according to the CDC.
Cases have also been reported in Iowa, Kansas, Michigan, Missouri, Nebraska, New Mexico, Oregon, Utah, Washington, Wisconsin and Wyoming, according to the CDC, which further notes that illnesses have occurred between Sept. 27 and Oct. 16 of this year.
This is a developing story. Please check back for updates.
(VANCOUVER ISLAND, CANADA) — Police in Canada said they have arrested six people and taken down an organized crime group believed to have produced tens of thousands of counterfeit cannabis-laced candy bars and edibles resembling popular name-brand products.
The takedown began early this month when the Pacific Region Royal Canadian Mounted Police federal policing investigators executed search warrants at two dispensaries and five separate residences on Vancouver Island in British Columbia, Canada, on Oct. 3, according to a statement from the Royal Canadian Mounted Police on Tuesday.
“These warrants were associated to an organized crime group allegedly involved in the production and distribution of illicit drugs, and contraband tobacco in Port Alberni and Nanaimo,” authorities said. “The dispensaries in question were Green Coast Dispensary in Port Alberni and Coastal Storm Dispensary located in Lantzville.”
Search warrants were also executed at a suspected stash site in Port Alberni, as well as a storage and production facility adjacent to Coastal Storm Dispensary, including two modular trailers where cannabis edibles were being produced, stored, and distributed, authorities said.
The list of items seized includes over 120,000 cannabis edibles with packaging resembling popular name-brand chocolate bars, potato chips, nacho chips, honey and other candies, including over 3 kilograms (6.6 pounds) of psilocybin mushrooms, 1,740 psilocybin capsules, over 400 psilocybin chocolate, candies and a multitude of other psilocybin products, 2.2 pounds of pressed cannabis resin, over 500 pounds of cannabis bud, more than 19 pounds of shatter, over 5000 cannabis vape cartridges, counterfeit cannabis-laced honey, five vehicles, two ATM machines containing cash, an estimated 164 master cases of contraband tobacco equating to 82,000 packs of cigarettes, over $400,000 in cash and a shotgun, police said.
“Although the contraband cannabis-laced candy bars and chips resembled professionally manufactured, packaged, and quality-controlled products, they were discovered to have been produced in the highly unsanitary, and heavily contaminated modular trailers,” authorities from RCMP said. “A preliminary assessment of the edibles also indicates that they had been treated with unknown amounts of THC, and likely cross-contaminated with other drugs and substances present in the trailers where they were being produced and packaged.”
Of equal concern, according to police, was the fact that the counterfeit snacks had packaging claims of possessing medicinal properties and dangerously high drug potency values, with many of the candy wrap labels claiming to be “100 times more potent than regulated cannabis products.”
“Given the highly contaminated and unsanitary conditions of the illicit drug production facility where these cannabis edibles were being produced, it is possible that the consumption of these products can lead to serious health risks,” RCMP said. “We urge members of the public to practice extreme caution if they already possess, or come across such products in the future, especially with Halloween being just around the corner.”
This investigation is ongoing and numerous drug-offence-related charges are being pursued.
(WASHINGTON) — The number of confirmed bird flu cases has risen in the U.S. to 31, federal health officials said on Thursday.
Washington health officials reported four presumptive positive bird flu cases over the weekend. Since then, two of the four cases have been confirmed, according to Dr. Nirav Shah, principal deputy director of the Centers for Disease Control and Prevention.
The confirmed and presumptive cases all worked with infected poultry at a commercial egg farm. All had mild symptoms and were given antiviral medication.
“These numbers of confirmed and presumptive cases will certainly shift as more cases are potentially identified in Washington state and then confirmed at the CDC,” Shah said during a press conference on Thursday.
Additionally, the number of cases in California rose to 15, which is the highest number in a single state so far.
The CDC also said there is no evidence that human-to-human transmission is occurring, sharing the results of an investigation that occurred after a Missouri case of bird flu was confirmed through routine influenza surveillance. Investigators found a household contact who had similar symptoms.
They also investigated the hospital where the bird flu patient was hospitalized, and they found that 112 health care workers had interacted with this patient, six of whom reported experiencing respiratory symptoms. Serologic testing, which looks at antibodies in the blood, confirmed the workers were not positive for bird flu.
Health officials’ investigation suggest the Missouri index patient and the household contact were both exposed to the same source, but further testing revealed the household contact did not meet criteria for a confirmed case.
The CDC said the risk to the general public is still low, and there is no evidence that the virus has mutated to better infect individuals.
Additionally, the CDC confirmed that laboratory company Quest Diagnostics will have a bird flu test soon available with a prescription from a provider for clinical purposes. Being prescribed the test would require being at risk for bird flu and experiencing symptoms of the virus.
Timeline of the bird flu outbreak
The outbreak began in early March when the U.S. Department of Agriculture announced a bird flu strain that had sickened millions of birds across the U.S was identified in several mammals this year. Later, health officials said they were investigating the illness among dairy cows, but assured there was no risk to the commercial milk supply.
The following month, the CDC said a human case of bird flu was identified in Texas and linked to cattle.
Since then, cases have been confirmed in California, Colorado, Michigan, Missouri and Washington. All the cases were among people who came into contact with sick dairy cows or infected poultry and all patients recovered with antivirals.
In late April, reports emerged that bird flu fragments had been found in samples of pasteurized milk. However, the fragments are inactive remnants of the virus and cannot cause infection.
Federal agencies maintain the U.S. commercial milk supply remains safe because milk is pasteurized and dairy farmers are required to dispose of any milk from sick cows, so it does not enter the supply.
In May, the CDC said in a summary that it is preparing for the “possibility of increased risk to human health” from bird flu as part of the federal government’s preparedness efforts, including filling doses of bird flu vaccine into vials to shore up the national stockpile.
Earlier this month, federal health officials announced they are providing $72 million to vaccine manufacturers to help ensure currently available bird flu vaccines are ready-to-use, if needed.
(NEW YORK) — The active ingredient found in popular medications for Type 2 diabetes and weight loss, including Ozempic and Wegovy, may reduce the risk of Alzheimer’s disease, a new study published Thursday finds.
Researchers from the Case Western Reserve University School of Medicine in Cleveland, Ohio, looked at three years of electronic records of almost 1 million patients with Type 2 diabetes, including those prescribed semaglutide.
Semaglutide falls under a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1s, which mimic the GLP-1 hormone that is produced in the gut after eating.
It can help produce more insulin, which reduces blood sugar and therefore helps control Type 2 diabetes. It can also interact with the brain and signal a person to feel full, which — when coupled with diet and exercise — can help reduce weight in those who are overweight or obese.
The team found that compared to seven other anti-diabetic drugs, semaglutide helped significantly lower the risk for Alzheimer’s disease, including other types of GLP-1s.
Semaglutide was associated with a 70% reduced risk when compared with insulin and 40% reduced risk when compared with other GLP-1 drugs, according to the study.
Women experienced an even lower risk for Alzheimer’s with semaglutide when compared to men, at about 80% compared to 50%, respectively.
However, women in the study were younger and more likely to have obesity or depression. They were also less likely to have heart disease, which may have led to their lower risk.
About 120,000 Americans die from Alzheimer’s disease in the U.S. each year, and it is currently the seventh-leading cause of death nationally, according to the Centers for Disease Control and Prevention.
While getting Type 2 diabetes under control may already lower the risk for Alzheimer’s disease, there may be additional dementia risk reduction for semaglutide, according to Rong Xu, lead researcher and professor of biomedical informatics at Case Western.
Semaglutide is considered to be “the most potent of the GLP-1s being that it has the greatest effect at hitting the receptor,” and, of the GLP-1s, it also produces the greatest weight loss, said Dr. Louis Aronne, the director of the Comprehensive Weight Control Center at Weill-Cornell Medical Center.
The greater potency of semaglutide may be why it has a stronger protective effect against Alzheimer’s.
Xu told ABC News that although there is no cure for Alzheimer’s disease, there are several risk factors including Type 2 diabetes and obesity that may be controlled.
“If we can address those risk factors, then we can prevent Alzheimer’s disease,” she said. “So, for semaglutide, there’s some preclinical evidence showing that this medication has neuro-protective effects and is also anti-inflammation, which can address a lot of risk factors associated with Alzheimer’s disease.”
This means GLP-1 medications may not only lower blood sugar to reduce the risk for Alzheimer’s disease, but they may also play a role in reducing neuro-inflammation.
“GLP-1 receptor agonists mitigate neuroinflammation, they mitigate oxidative stress, [and] they mitigate a number of things which occur systemically but also in the brain,” Nigel Greig, principal investigator at the National Institute on Aging, told ABC News.
However, the exact mechanism behind how GLP-1 medications reduce Alzheimer’s risk is unknown so more research is needed, according to Xu.
This is only [an] association, we cannot prove causality,” Xu said. “So, it’s not recommended to say people prescribed this medication can treat or prevent Alzheimer’s disease.”
“But this study can help people who already have Type 2 diabetes or obesity and are high risk for Alzheimer’s disease, it maybe can provide some evidence for medication selection,” she added.
For future research, Xu said she wants to examine if semaglutide can also lower the risk of other neurodegenerative diseases, including Parkinson’s disease and Lewy body dementia.
“GLP-1s provide benefit over and above weight loss alone. We are just beginning to understand the benefits of these drugs beyond weight loss alone,” said Aronne.
Itohan Omorodion, MD, MPH, is an internal medicine resident at George Washington University Hospital and a member of the ABC News Medical Unit.
(NEW YORK) — A new study suggests that GLP-1 agonist medications like Ozempic, which are used for diabetes management and weight loss, may help reduce the risk of overdose and alcohol intoxication in people with substance use disorders.
“It helps to underline another significant benefit of this class of medication,” Dr. Angela Fitch, the co-founder, and chief medical officer of knownwell, a company that provides weight-inclusive health care, told ABC News.
The large study, published in the journal, Addiction, analyzed the health records of 1.3 million people from 136 U.S. hospitals for nearly nine years. That included the records of 500,000 people with opioid use and more than 800,000 with alcohol use disorder.
Those who took Ozempic or a similar drug had a 40% lower chance of overdosing on opioids and a 50% lower chance of getting drunk compared to those who didn’t take the medication, the study found.
“The existing medications for treating substance use disorder are underutilized and stigmatized,” said Fares Qeadan, associate professor of biostatistics at Loyola University in Chicago. “These medications intended for diabetes and weight loss can help addiction without the associated stigma, which will be a new window for how to deal with addiction.”
The protective effects were consistent and even applied to people with Type 2 diabetes, obesity, or both conditions.
Fitch expressed optimism about the study’s results.
“As clinicians, recognizing that people can get double benefits from something is always helpful and as more obesity medications enter the market, this can help personalize treatments,” she said.
GLP-1 drugs, such as Ozempic and the combination drug tirzepatide also included in the study, mimic a natural hormone known as glucagon-like peptide-1 to help regulate blood sugar and insulin levels. For managing obesity and diabetes, these medications work by slowing digestion, reducing appetite, and enhancing insulin release in response to meals.
Scientists don’t fully understand how these drugs work yet. Some studies indicate that they activate specific “reward” receptors in the brain that make high-calorie foods less gratifying, so users eat less.
This could also be the reason these drugs may reduce cravings for alcohol and opioids. For example, a previous study found that adding the GLP-1, exenatide, was effective at helping some people with obesity and alcohol use disorder drink less.
The Addiction study does not prove that GLP-1 medications directly lower the risks of opioid overdose and alcohol intoxication, only that people taking them seemed to be helped. And it only included hospitalizations so it’s not clear if they will work as well in less serious cases.
Prescribing the drugs to treat substance use, at least for now, isn’t possible because they aren’t approved by the U.S. Food and Drug Administration for that purpose, Fitch pointed out.
“One of the challenges that we have as clinicians is we know that some of these benefits help patients. And not being able to get them access is very challenging,” she said.
People with substance use disorder keep using drugs or alcohol even though it causes problems in their life. According to the CDC, there are 178,000 annual deaths linked to excessive drinking. Over 75% of drug overdose deaths in 2022 involved opioids.
If you or someone you know is living with substance use disorder, free, confidential help is available 24 hours a day, seven days a week, by calling or texting the national lifeline at 988.
Dr. Faizah Shareef is an Internal Medicine Resident Physician and a member of the ABC News Medical Unit.
(BATTLE CREEK, Mich.) Hundreds of people gathered outside the WK Kellogg headquarters in Michigan on Tuesday calling for the company to hold up its promise to remove artificial dyes from its breakfast cereals sold in the U.S.
Nearly 10 years ago, Kellogg’s, the maker of Froot Loops and Apple Jacks, committed to removing such additives from its products by 2018.
While Kellogg’s has done so in other countries including Canada, which now makes Froot Loops with natural fruit juice concentrates, the cereals sold in the U.S. still contain both food dyes and a chemical preservative.
Food activist Vani Hari, also known as the Food Babe on social media, spoke to the crowd of demonstrators at the cereal giant’s offices in Battle Creek on Tuesday.
“I’m here for the moms, all the moms, who struggle to feed their children healthy food without added chemicals,” she said.
In response to the protests, Kellogg’s insisted its products are safe for consumption, saying its ingredients meet the federal standards set by the U.S. Food and Drug Administration.
The agency has said that most children experience no adverse effects from color additives, but critics argue the FDA standards were developed without any assessment for possible neurological effects.
The protests come in the wake of a new California law known as the California School Food Safety Act that bans six potentially harmful dyes in foods served in California public schools. The ban includes all of the dyes in Froot Loops, plus Blue Dye No. 2 and Green Dye No. 3.
The bill was passed by state legislators in August and signed by Gov. Gavin Newsom in September.
Studies suggest that consumption of said dyes and colorants banned under the new California School Food Safety Act may be linked to hyperactivity and other neurobehavioral problems in some children, as the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment outlined in a 2021 report.
While there are still thousands of chemicals allowed for use in our country’s commercial food system, many of those that have been reviewed by the Food and Drug Administration have not been reevaluated for decades. Red 40, for example, was last evaluated for health risks in 1971.
Reports from the American Academy of Pediatrics align with this push to reassess the safety of artificial food coloring.
California previously made history in October 2023, when Newsom signed AB 418 into law, a first-of-its-kind bill that bans four harmful chemicals from candy, cereals, salad dressings and other processed foods in the state starting in 2027.
That law will end the use of brominated vegetable oil, potassium bromate, propylparaben and Red Dye No. 3 in food products sold throughout the state.
Nicole Hallingstad credits her cat, Rudy, with finding her breast cancer.
Despite an unremarkable mammogram screening just seven months earlier, the 42-year-old knew something was wrong when Rudy kept pawing at something on the right side of her chest.
Hallingstad had another mammogram, which this time found a golf-ball-sized tumor in her breast that she said was from a fast-growing form of breast cancer.
After surgery, she needed both radiation and chemotherapy – but neither were available where she lived.
Hallingstad faced a difficult decision. Her options were to travel more than 1,000 miles once a month for chemotherapy and then relocate for six weeks of radiation treatment, or move to another state where she could get chemotherapy and radiation in one place. Hallingstad chose the latter.
“I was very fortunate that I was able to take the option to move and continue working and receive the care I needed,” Hallingstad told ABC News. “But that is a choice that is unsustainable for far too many Native women, and frankly, uncertain.”
Why was cancer care so inaccessible for Hallingstad? Because she lived in Alaska.
Hallingstad, a member of the Tlingit and Haida Native Indian Tribes of Alaska, faced profound barriers to breast cancer care that are shared by many American Indian and Alaska Native (AI/AN) women. These barriers have contributed to growing disparities over the last three decades.
“It’s often really difficult to get to a qualified health care center that is close to the rural areas where so many of our people live,” Hallingstad said. “And transportation is not readily available for many people to get the trip to the center, to get their screening to even have access to the kind of machinery that is needed for this important treatment work.”
A recent report by the American Cancer Society (ACS) showed that the rate of breast cancer deaths among U.S. women has decreased by 44% from 1989 to 2022. But that progress has not held true for all women, including AI/AN women, whose death rates have remained unchanged during that same time.
While AI/AN women have a 10% lower incidence of breast cancer than white women, they have a 6% higher mortality rate, according to the ACS.
The ACS also found that only about half of AI/AN women over 40 years old surveyed for the report said they’d had a mammogram in the last two years, compared to 68% of white women. That lack of timely screenings increased the risk of discovering cancer in more advanced stages, which in turn could result in higher death rates.
“This is a population for which we are very concerned,” Karen Knudsen, CEO of the American Cancer Society, told ABC News. “Given the mammography rates [of AI/AN women] that we’re actually seeing, which are well behind other women across the country.
Knudsen emphasized the need to “create that additional awareness about the importance of getting screened for breast cancer early because of the link to improved outcomes,” especially in Indigenous communities.
There are also cultural barriers to cancer care and awareness. “Culturally, we don’t often speak about very deep illness, because we don’t want to give it life,” Hallingstad said.
That fear, not necessarily shared by all Indigenous communities, is a common reason people from any background may choose not to discuss cancer risk, or to seek help if they think they have a serious health problem.
Melissa Buffalo, an enrolled member of the Meskwaki Nation of Iowa, is the CEO of the American Indian Cancer Foundation, where she works alongside Hallingstad. Her organization recently received a grant to study the knowledge and beliefs surrounding cancer and clinical trials among Indigenous people in Minnesota. Buffalo said she hopes to “create resources and tools that are culturally relevant, culturally tailored, so that we can help to build trust within these healthcare systems.”
Advocates like Buffalo and organizations like the ACS are also creating toolkits to help existing systems increase their outreach to AI/AN women. However, “there is not a ‘one size fits all’ approach to everything,” Dr. Melissa Simon, an OB/GYN at Northwestern University and founder of the Chicago Cancer Health Equity Collaborative, told ABC News.
“We have to also acknowledge that the patient has some variation too, just like the cancer itself. To treat it has some variation,” Simon said.
“We have to talk about it,” Hallingstad said about breast cancer in the Indigenous community. “We need to understand treatment options. We need to bring care facilities closer and we need to make sure our populations are being screened and are following treatment.”
Jade A. Cobern, MD, MPH is a physician board-certified in pediatrics and preventive medicine and a medical fellow of the ABC News Medical Unit.
Sejal Parekh, M.D., is a board-certified, practicing pediatrician and a member of the ABC News Medical Unit.
(NEW YORK) — People who were diagnosed with severe COVID-19 infections from the first wave of the pandemic could face double the risk of heart attack and stroke, a new study has found.
The study, published this week in the journal Arteriosclerosis, Thrombosis, and Vascular Biology and supported by the National Institutes of Health, found the elevated risk could last for up to three years
Researchers focused on the long-term cardiovascular risks for unvaccinated people who were sick with the virus during the first wave of the COVID-19 pandemic in 2019 and 2020.
Compared to someone who never had COVID-19, the likelihood of heart attack, stroke and death doubled for anyone who was ever ill with the virus, and was four times higher for people who required hospitalization, the study found.
The elevated danger persisted for more than three years after the initial infection, which, according to the study, posed a serious cardiovascular threat comparable to that of type 2 diabetes.
“Findings suggest severe COVID-19 infection as a catastrophic component,” Dr. Hooman Allayee, the study’s principal investigator, told ABC News. “Cardiovascular mortality trends from 2010 to 2019 were steadily going down. Then, all of a sudden, between 2020 and 2022, ten years of work [was] completely wiped out because of COVID-19.”
People with blood types A, B and AB were especially vulnerable to increased cardiovascular risk from COVID-19, while people with type O blood had a reduced chance of facing such issues, according to the study.
“Blood type is known to be associated with heart attack and stroke risk,” said Allayee, who is a professor of population and public health sciences at the Keck School of Medicine at the University of Southern California. “If your blood type is A, B or AB, the virus is more likely to infect you and makes these blood cells open to viral entry.”
The study analyzed individuals from the UK Biobank, a large medical database consisting primarily of data taken from older, wealthier and predominantly white participants. However, similar studies looking at other populations came to nearly identical conclusions, according to Allayee.
The study emphasized the importance of COVID-19 vaccinations, Allayee said.
“No matter what vaccine you got, just six months after the vaccination or the booster, the chance of heart attack and stroke went down,” he said. “But immunity wanes over time, which is why you need the boosters. If not, you could be susceptible to getting severe COVID again.”
Anyone who has ever had a severe COVID-19 infection, especially if they required a hospital stay, should discuss the potentially increased health hazards caused by the virus with their health care provider, Allayee stressed.
“Talk to your doctor and start the discussion with your physician,” he said. “It’s not going away, so we have to start talking about it. Stay on top of your vaccinations and boosters and get regular check-ups.”
Mahir Qureshi, M.D. is an internal medicine physician resident at Cooper University Hospital and a member of the ABC Medical Unit.
(ST. PETERSBURG, Fla.) — Residents of St. Petersburg — on Florida’s central-west coast — were temporarily left without clean drinking water after a water main break occurred during Hurricane Milton.
City officials said the break caused them to shut off potable water services at 12 a.m. ET on Thursday until repairs could be made.
“Residents and businesses should prepare for this temporary shutdown, which is expected to last until the necessary repairs can be completed,” the city said in a release.
“Repairs to the water line will begin once it is safe for crews to be outside. Affected areas may already be experiencing low water pressure or service interruptions,” the release continued.
By Thursday afternoon, officials said potable water service was back but that pressure may be low.
Additionally, officials said a helicopter from the Sheriff’s Office in Pinellas County, where St. Petersburg is located, was assisting in searching for water main leaks.
Typically, water distribution systems are kept under enough pressure that, even when there are cracks, dirty water and contaminants are unable to get in. However, when a water main breaks, system pressure drops and pathogens are allowed to seep in.
“When water main breaks, we can see the obvious water coming out, and we think, ‘Oh, we’re losing water.’ But what’s happening in other areas of the system is the pressure is going down,” Dr. Sandra McLellan, a distinguished professor at the University of Wisconsin-Milwaukee’s School of Freshwater Sciences, told ABC News.
“What is in the soils can seep into the pipes. … If there’s a water main break and there’s a lot of flooding or a lot of rainwater, then all of that sewage that’s kind of sitting around these pipes and in the soil can seep into our drinking water systems,” she continued.
Some of the contaminants may be visible to the naked eye and just lead to discoloration or cloudy water. Other containments may not visible and lead to serious illnesses including E. coli or norovirus.
McLellan said people may not realize their drinking water is contaminated until they experience symptoms of illness.
“There’s no real way to easily test for pathogens in the water because they’re kind of at low levels,” she said. “So it isn’t that everybody’s going to get sick, but, if 100 people drink the water, chances are one or two people may be drinking a part of the water that contains those pathogens.”
Dr. Norman Beatty, an assistant professor of medicine at the University of Florida College of Medicine and an infectious disease physician, told ABC News that ingesting bacteria found in storm surge waters can lead to diarrheal illnesses, but can progress to sepsis in some and lead to hospitalization.”
The city issued a boil water notice for water used for drinking, cooking and brushing teeth and said it will remain in place as repairs continue.
Beatty recommends using bottled water until the water is drinkable or boiling water.
“When boiling water, start the timer once you reach a rolling boil and after one minute, let the water cool naturally. If water is cloudy, let is settle and then filter through a clean coffee filter paper or clean cloth,” he said.
McLellan said after a main break, crews will dig up the street, fix the pipes and restore pressure. She added that after pressure is restored, one flushing of the pipes should restore clean drinking water.
If people are worried about their water supply, she recommended they use a pitcher with a home water filter before drinking tap water.
“I think people think, ‘Oh, if my water’s off, of course there’s a problem. But if my water’s on, the water will be safe,'” she said. “But we really have to remember, in areas where there’s hurricanes, there’s certainly damage that could happen, so it’s better to be on the safe side.”
On Wednesday evening, St. Petersburg officials also turned off power to two sewer treatment plants in the northeast and southwest part of the to protect employees and the facilities from potential storm surges.
As of Thursday morning, sewer services were back online, and city crews were out inspecting and re-energizing both plants.
Hurricane Milton made landfall on Florida’s west coast as a Category 3 hurricane Wednesday night.
Gov. Ron DeSantis said Thursday morning that the hurricane “thankfully” spared the state from “the worst-case scenario” but that flooding Is expected to continue over the next several days.
(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.
