Bird Flu spreads to cats, concern for human infections heighten


So far, 43 types of mammals have tested positive for bird flu in the U.S.


Lazy cat
The bird flu cases are rising in cats. A pet from the Champaign-Urbana area was recently diagnosed infected with the virus.
Photo: Annette Meyer/Pixabay

(Urbana) - A growing number of cases of H5N1 avian influenza, commonly known as bird flu, have been detected in domestic cats across the United States, raising concerns about its potential transmission to humans. Veterinary experts and public health officials are warning pet owners to be vigilant as the virus spreads across multiple states and is linked to contaminated food sources.

Dr. Leyi Wang, a virologist and professor of veterinary medicine at the University of Illinois Urbana-Champaign, recently confirmed the presence of H5N1 in a cat at the university’s Veterinary Diagnostic Laboratory. The U.S. Department of Agriculture (USDA) has reported 130 cases of bird flu in domestic cats, spanning 23 states, including Illinois. Since 2022, 126 domestic cats have been infected, with around half of those cases occurring in 2024. Many cats were exposed through contaminated food or raw milk.

Lethality and Transmission Risk
"Bird flu H5N1 infections in cats are usually serious and life-threatening, with a high mortality rate. Infected cats show severe clinical signs such as lethargy, fever, loss of appetite, difficulty breathing, discharge from the eyes and nose, and neurological issues like tremors, seizures, incoordination or blindness," Wang explains. "Domestic cats are companion animals and have close contact with humans, potentially transmitting viruses to owners. A previous report revealed a cat-to-human transmission of influenza A virus, so H5N1 transmission might be possible as well."


Infections have been reported most often after prolonged and unprotected exposure to an infected animal.

Although no confirmed cases of cat-to-human transmission of H5N1 have been recorded in the current outbreak, Wang and other experts warn that as the virus circulates in mammals, the risk of mutation increases. "Previously, H5N1 had limited infection in mammals. However, the new H5N1 involved in outbreaks since 2022 mutated and acquired the capability to infect different mammal species including domestic and wild cats. So far, 43 types of mammals have tested positive for bird flu in the U.S., with domestic cats being the highest number," Wang says.

Pathways of Infection
The Centers for Disease Control and Prevention (CDC) states that people can be infected with avian influenza viruses through contact with infected wild, stray, feral, or domestic animals. Infections have been reported most often after prolonged and unprotected exposure to an infected animal. The CDC has previously documented avian influenza transmission from mammals to humans in the U.S., including a case involving a cat in New York City in 2016 and a cow in 2024.

The virus has been detected in poultry and cattle, allowing it to enter the raw food supply. Concerns over food contamination led the U.S. Food and Drug Administration (FDA) to recall Savage Cat Food Large Chicken Boxes (84 ounces) and Small Chicken Boxes (21 ounces) due to the potential presence of H5N1. These products, with a “better if used by” date of November 15, 2026, were distributed in multiple states, including Arizona, California, Colorado, Maryland, New York, and Pennsylvania.

Pet owners who have fed their cats the recalled products should watch for symptoms of bird flu, including fever, lethargy, loss of appetite, reddened or inflamed eyes, nasal and eye discharge, difficulty breathing, and neurological signs such as tremors, seizures, or blindness. If a cat exhibits these symptoms, immediate veterinary attention is advised.

Public Health Concerns
Public health experts fear that as H5N1 spreads among mammals, the likelihood of a pandemic increases. The New York Times recently reported that domestic cats could serve as a critical pathway for the virus to evolve and potentially become more transmissible to humans. If the virus mutates or swaps genes with another flu virus, it could pose a greater threat to human populations.

"If you work with animals, wash your hands well after interacting with poultry, livestock or animals outside the household. I also would suggest changing clothing and shoes after interacting with animals or birds with unknown health status, before interacting with your own pets," Wang advised.

Prevention and Protection
With no available vaccine or antiviral treatment for H5N1 in cats, prevention is key. Experts recommend keeping cats indoors to limit exposure to infected birds and wildlife. Pet owners should also avoid feeding raw meat or raw milk to their pets and ensure they do not come into contact with potentially contaminated food sources.

Wang stresses the importance of vigilance among pet owners. "Cat owners should contact their veterinarians if they are concerned their pet has contracted bird flu. Tell the veterinarian if your pet has been exposed to raw meat, raw milk, backyard birds or wild waterfowl. Unfortunately, only supportive care is available for cats with bird flu, and no antiviral drugs are yet available."

Beyond pet care, experts urge the public to remain cautious when handling animals and animal products. Personal protective equipment (PPE) is recommended for veterinarians and those working closely with animals at risk of infection.


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Allergy season is just around the corner; some tips that might help you be less miserable

Allergy season sneeze
Photo: PEXELS/Edward Jenner

by Tim Ditman
OSF Healthcare

DANVILLE - Spring allergies will be here soon. If you’re suffering from a runny or congested nose, watery or itchy eyes or sneezing, it’s tempting to grab the first medicine that catches your eye at the pharmacy or rifle through the bathroom drawer for some pills you’re hanging on to.

Not so fast, says Maddy Draper, APRN, a health care provider at OSF OnCall. She says it’s important to know what to take and when in order to avoid side effects that can be serious.

OSF ARPRN Maddy Draper
Photo provided
Maddy Draper, APRN

What to take
Draper says an antihistamine like Astepro, Zyrtec, Allegra or Benadryl is a typical first line of defense.

“There are also decongestants for severe nasal congestion or sinus pain and pressure,” Draper adds. Sudafed is a well-known decongestant.

If a more severe case brings symptoms like face swelling or wheezing, Draper says treatment could be a steroid like Flonase or prednisone.

For more chronic (in other words, long term) allergy cases, the U.S. Food and Drug Administration says a provider may recommend immunotherapy to build up a tolerance. This could be an injection or a tablet under the tongue.

Misuse
It may not seem like over the counter allergy medications are ripe for misuse, but it can happen.

Draper says antihistamines, especially Benadryl, can make you drowsy. If you take too much or take it at the wrong time, you could, for example, find yourself sleepy behind the wheel. Or your attentiveness at work or school could suffer.

On the flip side, Draper says Sudafed can make you jittery, irritable or cause heart palpitations (the feeling of an irregular heartbeat). This could be a big issue, she says, for people with a heart condition.

“We want to avoid nasal sprays for people with nasal trauma. Things like a deviated septum or nasal sores,” Draper adds. “Putting something up the nose could cause further tissue damage.”

Draper says to take medication as directed by your provider. Or if it’s over the counter, follow the label instructions. She says these medications typically take a couple days to start working. So don’t be tempted to take an extra dose if you’re not seeing relief right away.

Think of the children! (and seniors)
Children and seniors may be more impacted by the side effects of allergy medications. An older adult who takes Benadryl, for example, may be drowsy to the point that they fall and suffer a serious injury.

So, Draper says providers will typically start with an antihistamine that doesn’t make you super drowsy. She says Zyrtec is approved for ages six months and up, and that’s often where providers will start.

“Any antihistamine label is going to tell you to consult your provider for use under the age of two,” Draper says. “So you’ll need to be seen by a provider or your pediatrician.” This could be a virtual visit or a message to your provider in your patient portal.

Plan ahead
Draper says knowing your allergy triggers and acting accordingly is key to avoiding unpleasant symptoms. For example, you know grass clippings will cause an allergic reaction, but you have no choice but to mow the lawn.

“Primary care providers and allergists typically recommend starting the medication prior to exposure,” Draper explains. “If you know you’re going to be outside on that windy, dry day to mow, start the antihistamine a couple days prior so it can fully take effect.”

If you can’t get a handle on a known allergy, or if you have unexpected allergy symptoms, Draper says it’s never a bad idea to go to an urgent care.

Or if you find yourself looking for an over the counter medication option: “Just ask the pharmacist,” Draper suggests. “They’ll give you recommendations.

“There’s usually a specific aisle for allergies,” she adds. “Find the right antihistamine. Flonase is another big one we see people use.”


Staying berry healthy; FDA steps up with strategy to address contaminated food imports

SNS - Berries are known as a superfood, essential to healthy living. In addition to being an excellent source of vitamins, minerals, fiber, and antioxidants, they are known to reduce the risk of many age-related conditions, including heart disease, cancer, and arthritis. However, berries, if not harvested and handled correctly, can make you super sick.

The FDA recently advised consumers to exercise caution when eating fresh and frozen imported berries due to concerns about potential links to outbreaks of enteric virus infections, including hepatitis A virus (HAV) and norovirus (NoV). These outbreaks have been associated with fresh and frozen berries exported globally, including to the United States. The Food & Drug Administration has adopted a new strategy to limit consumer exposure to the two viruses.


fresh and frozen berries
Photo provided

Frozen berries are commonly used as ingredients in various foods. While they are often baked into pies and other goods, they are also used raw in fruit salads and smoothies, which have been linked to foodborne illness outbreaks. Between 1997 and 2016, the FDA reported three hepatitis A virus outbreaks and one norovirus outbreak linked to frozen berries.

"While no enteric virus outbreaks associated with domestic berries have been reported in 35 years, there have been outbreaks linked to imported fresh and frozen berries," the FDA said in a statement. The most recent HAV outbreaks in the United States occurred in 2022 and 2023, with imported berries from the same grower identified as the source. "Outbreaks reported since 1997 have been linked to imported fresh and frozen berries. However, hygienic practices and challenges in controlling enteric viruses in berries and other hand-harvested produce apply globally."

Enteric viruses, such as hepatitis A and norovirus, are primarily spread through the fecal-oral route, which occurs when food, water, or surfaces contaminated with fecal (or vomit) matter is consumed. For example, strawberries, raspberries, and blackberries can become contaminated with bacteria or viruses if handled by an infected worker who does not follow proper hygiene after using the toilet. Because berries are often eaten raw and are hand-harvested, they can be particularly vulnerable to contamination if strict hygiene practices are not followed.

Contamination can also occur via water or surfaces during harvesting and packaging. Contrary to popular belief, freezing preserves berries but does not kill viruses, which can survive at low temperatures. Noroviruses, for example, can withstand temperatures as high as 145°F.

According to the Centers for Disease Control and Prevention (CDC), norovirus outbreaks most commonly occur in healthcare facilities, restaurants, catered events, schools, childcare centers, and cruise ships, where food handling procedures maybe suboptimal due lack of training or compliance by workers.

What are Enteric Viruses?
Enteric viruses infect the digestive tract and cause symptoms such as nausea, diarrhea, vomiting, and stomach pain. Typically, a norovirus bout lasts 12 to 60 hours. These viruses are primarily spread through contact with feces or infected animals. People with weakened immune systems or underlying health conditions are at higher risk of severe illness. HAV symptoms can include fatigue, nausea, vomiting, abdominal pain, jaundice, dark urine, and pale stool.

The FDA attributed the contamination of imported berries to lapses in food safety systems and prevention measures by overseas suppliers. "Key factors to consider in preventing outbreaks include proper hygienic practices by field workers, management of sanitary facilities, prevention of cross-contamination during field and processing operations, and monitoring viral carriage among farm and facility workers," the agency stated.

HAV is a vaccine-preventable, short-term infection that does not become chronic. Most infected individuals recover completely within weeks. However, untreated infections can lead to severe complications in older adults, immunocompromised individuals, or those with underlying health issues.

FDA focuses on prevention and spread
To prevent future outbreaks, the FDA announced a strategy to minimize infection risks for the public. The plan includes:
  • Promoting high compliance rates with FDA food safety requirements.
  • Encouraging the berry industry to implement consistent pre- and post-harvest sanitary practices globally and to use root cause analysis when food safety failures occur.
  • Expanding scientific knowledge about detecting and mitigating viruses in fresh and frozen berries, agricultural water, and production environments.
  • Incentivizing public health measures, such as immunization programs, to promote worker health.

The FDA aims to identify sources of contamination using a thorough scientific approach to improve virus detection and prevention before they become consumer health risks.

“Collaboration between regulators, the global berry industry, and other stakeholders has been critical for developing this strategy. We look forward to ongoing collaboration to ensure its success and to prevent foodborne illness,” said Conrad Choiniere, Director of the Office of Microbiological Food Safety at the FDA’s Human Food Program.


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Early detection: Bioimpedance used in new portable breast cancer screening device

Photo provided

NewsUSA - The ScanEase OneSense device is a screening tool for diagnosing breast cancer. The device facilitates an examination that is accessible to patients of any age and body type, allowing for self-examination due to its user-friendly design in the privacy of their home. The results help assess the risk of new tissue formations in the breast. The higher the risk factor on the BI-RADS scale, the greater the likelihood of malignant tissue degeneration. In light of this, the OneSense scanning device is recommended for the primary diagnosis of breast tumors in outpatient settings and for at-home self-examinations. The scan results are visible through an app on your smartphone, which will advise whether you should consult with a physician.

Measurement method:
The device measures the distribution of conductivity between the electrodes on the surface of the breast, which is influenced by the distribution of blood flow in the breast tissue. The device utilizes the well-known principle of bioimpedance, measuring the difference in electrical conductivity between healthy and cancerous tissues, as tumor growth significantly increases blood flow. This allows the device to demonstrate a high specificity in breast cancer diagnostics. The results obtained from using the device will enable physicians to enhance the diagnostic quality of fibroepithelial and non-epithelial breast formations, as diagnostic errors occur in 20% to 60% of cases during routine patient examinations. The widespread use of ScanEase scanning technology will reduce the reliance on X-ray mammography and MRI examinations as routine methods for assessing breast health, thereby decreasing radiation exposure.

A unique software with a proprietary AI-based algorithm has been developed, enabling users to determine the risk factor for the presence of neoplasms in breast tissue immediately after screening, with an accuracy of up to 85%. The bioimpedance method identifies areas of increased electrical conductivity in a woman's mammary gland, that are formed due to increased blood flow, which is characteristic of tumor development.

The interpretation of the obtained data is performed by an AI-based system using the international BI-RADS scale, which indicates a complex 'risk factor' parameter on a specialized point scale. This approach standardizes and digitizes the data description using original algorithms, allowing for an assessment of the patient's risk according to the BI-RADS scale. The method makes it possible to reliably divide patients into 3 groups of threats based on the magnitude of the risk factor: low, medium and high risk.

The user of the scanning device can immediately view the results through an app on their smartphone. If a medium or high-risk result is indicated, the person should promptly contact their physician for further diagnosis.

In early 2025, the device will enter FDA clinical trials on a fast-track basis for a non-invasive medical trial. Upon final FDA approval, the device will be available for purchase online, with a projected cost of $350. The device can be shared among friends and family, reducing the cost per person using it. View the Company’s website at www.scanease.co or send an email to info@scanease.co to request more detailed information.


Related articles:

Updated COVID-19 vaccine approved by FDA coming soon

by Matt Sheehan
OSF Healthcare

Photo provided
Dr. Doug Kasper
PEORIA - The fall virus season is upon us, and the U.S. Food & Drug Administration just approved one of the newest tools to protect Americans from severe illness.

The updated COVID-19 vaccine is expected to be available at pharmacies around the country in the coming weeks.

The mRNA vaccine is not a booster, says Doug Kasper, MD, an infectious disease specialist with OSF HealthCare. He says it’s recommended for a much broader portion of the population.

"The vaccine is now recommended for everybody 6 months and older as a one-time, once-a-year vaccine," Dr. Kasper says. “The vaccine has been updated. For people who are at really high risk, those 65 and older or with respiratory conditions, they may get a second shot. This would be in a six-month interval in the springtime.”

Does the vaccine prevent me from getting COVID-19?
The quick answer? No, much like you find with the annual influenza vaccine.

"The vaccine seeks to protect severe outcomes associated with COVID-19. It doesn't protect you from getting COVID, it tries to decrease the severity of how sick you would get," Dr. Kasper says.

While there has been an uptick in COVID-19 cases recently, Dr. Kasper says there has not been an increase in COVID hospitalizations. He attributes this to robust natural immunity in the population and adding this COVID-19 vaccine is just another way to protect yourself from severe illness.

FDA’s “What to Know” sheet
The 2024-2025 formula has been updated to protect against the Omicron variant KP.2.

  • Unvaccinated individuals 6 months through 4 years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated, authorized Moderna COVID-19 vaccine.
  • Individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
  • Individuals 5 years through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines; if previously vaccinated, the dose is administered at least two months after the last dose of any COVID-19 vaccine.
  • Individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty (manufactured by Pfizer BioNTech) or the updated, approved Spikevax (manufactured by Moderna); if previously vaccinated, the dose is administered at least two months since the last dose of any COVID-19 vaccine.
  • Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine fact sheets.
Commercial retailers are the way to go
As the vaccines from Pfizer and Moderna become available, the Centers for Disease Control & Prevention (CDC) will publish a pharmacy lookup website at https://www.vaccines.gov/en/vaccines.gov to help people find the nearest vaccine locations.

Dr. Kasper says the best bet at getting a vaccine appointment for COVID-19 or influenza, is through pharmacies at local commercial retailers like Target, Walgreens, CVS or Walmart.

Free COVID-19 home tests are coming back
“The U.S. government will make the at-home COVID testing available for free again this year. You can request up to four home tests that will be delivered to your address for free,” Dr. Kasper says. That gives people another option for testing if they think they're developing signs of COVID even after receiving a vaccine, which can be another way to avoid wait lines at urgent cares, ERs or primary care clinics, and to keep themselves isolated until symptoms have resolved.”

The U.S. Department of Health & Human Services reports that COVIDTests.gov will be the website to order from once the website is active.

Status of the Novavax vaccine
A third manufacturer, Novavax, makes a protein-based vaccine similar to influenza vaccines. While it hasn’t been approved by the FDA, Dr. Kasper suspects it will be soon.

"It likely will be approved, and Novavax has been a prior manufacturer of COVID-19 vaccines. That is a third option that will be coming that isn't mRNA based for people to consider if they had an adverse reaction with Pfizer or Moderna in the past,” Dr. Kasper says.

Can I get the COVID-19 and flu vaccine at the same time?
"There's no issue with timing on getting the COVID and influenza vaccines. The RSV vaccine is recommended to be given separate," Dr. Kasper says. “Most of that has to do with the fact they weren't studied together, there's not an adverse issue with it. For the population, COVID and influenza are recommended across almost all age groups. RSV is for our older population, so we recommend spacing that out by a week or two.”

For all vaccine questions, Dr. Kasper recommends speaking with your primary care team to review your options.


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Major leaps made in Alzheimer's research, three FDA approved treatments slows mental decline

Illustration: StatePoint
StatePoint Media - 2023 was a landmark year for Alzheimer’s disease research, including advancements in treatment, risk factors and diagnosis. Here are five significant discoveries made this year:

There are three new approved treatments for Alzheimer’s, with a fourth on the way

In July, the U.S. Food and Drug Administration (FDA) granted traditional approval for Leqembi for mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia. This treatment slows cognitive decline and can help people with early Alzheimer’s maintain their independence.

In June 2021, the FDA granted accelerated approval to Aduhelm for the same purpose. At the Alzheimer’s Association International Conference (AAIC) in July 2023, Lilly reported positive results for a third similar treatment: donanemab. The company expects FDA action in early 2024.

In May, the FDA approved the first treatment for agitation in people with Alzheimer’s — brexpiprazole.

Hearing aids could slow cognitive decline for at-risk older adults

In the largest clinical trial to investigate whether a hearing loss treatment can reduce risk of cognitive decline, researchers found that older adults with hearing loss cut their cognitive decline in half by using hearing aids for three years.

The intervention included hearing aids, a hearing “toolkit,” and ongoing instruction and counseling. Though the positive results were in a subgroup of the total study population, they are encouraging and merit further investigation.

Blood tests for Alzheimer’s are coming soon.

Blood tests show promise for improving how Alzheimer’s is diagnosed. Advancements reported for the first time at AAIC 2023 demonstrate the simplicity and value to doctors of blood-based markers for Alzheimer’s.

Blood tests are already being implemented in Alzheimer’s drug trials. And they are incorporated into proposed new diagnostic criteria for the disease. Blood tests — once verified and approved by the FDA — would offer a noninvasive and cost-effective option for identifying the disease.

First-ever U.S. county-level Alzheimer’s prevalence estimates

The first-ever county-level estimates of the prevalence of Alzheimer’s dementia — in all 3,142 U.S. counties — were reported at AAIC 2023. For counties with a population of more than 10,000 people age 65 and older, the highest Alzheimer’s prevalence rates are in:

• Miami-Dade County, Fla. (16.6%)

• Baltimore City, Md. (16.6%)

• Bronx County, N.Y. (16.6%)

• Prince George’s County, Md. (16.1%)

• Hinds County, Miss. (15.5%)

Certain characteristics of these counties may explain the higher prevalence, including older age and a higher percentage of Black and Hispanic residents, which are communities disproportionately impacted by Alzheimer’s disease. According to the Alzheimer’s Association, these statistics can help officials determine the burden on the health care system, and pinpoint areas for culturally-sensitive caregiver training.

Chronic constipation is associated with poor cognitive function

Approximately 16% of the world’s population struggles with constipation. This year, researchers reported that less frequent bowel movements were associated with significantly worse cognitive function.

People in the study with bowel movements every three days or more had worse memory and thinking equal to three years of cognitive aging. These results stress the importance of clinicians discussing gut health with their older patients.

To learn more about Alzheimer’s and dementia research, plus available care and support — and to join the cause or make a donation — visit the Alzheimer’s Association at www.alz.org.

While there is still much to learn about Alzheimer’s, 2023 was a year of discovery, giving researchers and families impacted by the disease hope for the year ahead.


Related Sentinel articles
• • • •

Viewpoint |
Navigating dementia during the holidays

Holidays can be a wonderful time of year when families get together and catch up on each other’s busy lives. All too often is also the time that you may find that things aren’t quite the same with our aging family members.

Those twenty-minute calls once or twice a month made everything seem a okay with the parents or grandparents. But now, you have noticed the signs and symptoms of dementia are starting to show.


Making Alzheimer's just a memory: An in-depth look and the work to find a cure

Although the COVID-19 pandemic turned the world upside down, the rapid development of multiple vaccines has spurred hope that treatments – or even potential cures – may be found for other devastating conditions. One such candidate is Alzheimer’s Disease.


• • • •

Backed by plenty of public and private cash, Rapid Covid Tests will be in stores soon

by Hannah Norman

Scientists and lawmakers agree that over-the-counter covid tests could allow desk workers to settle back into their cubicles and make it easier to reopen schools and travel.

But even as entrepreneurs race their products to market, armed with millions of dollars in venture capital and government investment, the demand for covid testing has waned. Manufacturing and bureaucratic delays have also kept rapid tests from hitting store shelves in large numbers, though the industry was energized by the Food and Drug Administration’s greenlighting of two more over-the-counter tests Wednesday.

Corporate giants and startups alike plan to offer a dizzying array of test options, most costing between $10 and $110. Their screening accuracy varies, as does the way consumers get results: collection kits mailed back to a lab, devices synced with artificial intelligence-enabled apps on a smartphone that spit out results within 15 minutes, and credit card-sized tests with strips of paper that must be dipped into a chemical substance.

"At-home tests are one of the key steps to getting back to normal life," said Andy Slavitt, a member of the White House COVID-19 Response Team, during a February briefing.

The Biden administration announced in March it will allocate $10 billion from the recently passed stimulus package for covid testing to expedite school reopenings, and earlier said it would invoke the Defense Production Act to manufacture more at-home tests. Separately, the federal government has already sent millions of Abbott Laboratories’ BinaxNOW rapid tests to states, and California, for instance, is giving 3 million of them to its most disadvantaged school districts for free.

Large employers, like Google, sports leagues and the federal government, have already shelled out millions to regularly test their workers. Amazon just received emergency use authorization from the FDA for its own covid test and home collection kit, which it intends to use for its employee screening program.



In February, the Biden administration cut a $232 million deal with Ellume, whose rapid antigen test was authorized by the FDA in December. Paired with an app, the test takes 15 minutes to analyze after a nose swab.


Individuals who want to buy over-the-counter tests can bill their health insurance plans, which are required by the federal government in most cases to fully cover covid tests that have been authorized by the FDA.

Everlywell, based in Austin, Texas, is an at-home diagnostic company that already sells its collection kit to consumers through its website and Walgreens, and will soon offer same-day delivery via DoorDash in a dozen cities. Dr. Marisa Cruz, Everlywell’s executive vice president of regulatory and clinical affairs, said buyers can seek reimbursement from their insurance plans for the kit’s $109 cost. The tests are also eligible for purchase with pretax dollars from health savings or flexible spending accounts, she said.

Even with vaccines, epidemiologists say, rapid tests are desperately needed because more testing, along with mask-wearing and physical distancing, will get people back in offices and classrooms and help catch cases that go undetected. A report by the Centers for Disease Control and Prevention found that, of people with active infections, 44% reported no symptoms.

But the market for over-the-counter tests is risky. Demand for testing has plunged dramatically since the height of the winter surge and may not rebound as more people are vaccinated.

'You clearly are at risk of missing the market,' said Michael Greeley, co-founder and general partner at Flare Capital Partners, a venture capital firm focused on health care technology.

But Douglas Bryant, president and CEO of Quidel Corp., remains unfazed, even after the diagnostics manufacturer’s testing demand dropped by about one-third in the past two months.

"The level of testing for people with symptoms and the 'worried well,' who see others getting tested and think they should, too, is subsiding," Bryant said. "But once we start to get more people vaccinated, the government will move from campaigning to get people vaccinated to saying, 'Please test yourself regularly so we can get back to work.'"

Quidel, headquartered in San Diego, recently unveiled its latest test, the QuickVue At-Home COVID-19 Test, which takes 10 minutes to detect the coronavirus by homing in on specific proteins, called antigens. The FDA authorized the test for over-the-counter use Wednesday, and Quidel plans to announce retail partners in the coming weeks.

The FDA said in mid-March it would speed the pipeline for “screening testing,” including at-home covid tests that don’t require consumers to have symptoms or a prescription.

In February, the Biden administration cut a $232 million deal with Ellume, whose rapid antigen test was authorized by the FDA in December. Paired with an app, the test takes 15 minutes to analyze after a nose swab.

The Australian company currently ships hundreds of thousands of test kits a week to the U.S. from its factory in Brisbane to large companies and the Department of Defense. It plans to be on the shelves of multiple pharmacies by the second half of the year and in one major retailer in April, said Dr. Sean Parsons, the company’s founder and CEO.

"We are going as fast as we can possibly go," he said.

The main holdup for Ellume has been getting enough swabs for its production line. The company is building a factory in the U.S. to reduce international shipping costs and increase production.

Abbott, which dominates the rapid-test market, said in January it expects to sell 120 million BinaxNOW antigen tests to consumers in the first half of the year. People who take the test now must do so under observation by telemedicine platform eMed. But Abbott received authorization from the FDA this week for an over-the-counter version that won’t require remote observation or a prescription. The test will be available in U.S. stores in the coming weeks, the company said.

Throughout the pandemic, the government has depended heavily on medical device behemoth Abbott’s testing options. The company’s rapid-diagnostics arm alone has snared $673 million in federal contracts to combat the coronavirus, according to a ProPublica database. This includes bulk purchases made by the Defense Department, the national prison system, Immigration and Customs Enforcement, the State Department and former President Donald Trump's office.

But antigen tests sometimes report false negatives, particularly among people without symptoms, noted Dr. Jac Dinnes, who co-authored a review of 64 covid test studies. By comparison, polymerase chain reaction (PCR) tests — generally employed by commercial labs — are more sensitive. PCR tests search for the virus’s genetic material over multiple testing cycles, which magnifies what’s in the swab sample, requiring a much smaller viral load for detection.

Antigen tests are the basis for most at-home screening, but the FDA has also authorized two at-home options — made by Lucira Health and Cue Health — that use molecular processes similar to a PCR test.



"I always like to tell people that it is as easy to use as toothpaste."


Still, many experts support the widespread distribution of cheap, rapid tests, even if they aren’t as sensitive as lab-run alternatives, and see a demand. In Germany, the supermarket chain Aldi began selling rapid tests in early March, roughly $30 for a five-pack, and sold out within hours. One recent study found that if a pack of tests was mailed to every household in the U.S. — even assuming that up to 75% would go into the garbage — they would save thousands of lives and avert millions of infections.

"Don’t let perfect be the enemy of good," said study co-author and Yale University professor A. David Paltiel. "This doesn’t have to work perfectly to make a huge difference."

Some companies are working on rapid-testing options that more precisely read samples, such as Gauss.

The Menlo Park, California, health tech company, which before the pandemic created an artificial intelligence-based app to measure surgical blood loss in real time, aims to harness its expertise to improve on the basic antigen test. It took about a week for CEO Siddarth Satish to raise $30 million of venture capital last October.

Its covid-testing app uses facial recognition software to confirm that test-takers correctly swab their noses. The app provides step-by-step instructions and timers. After 15 minutes, an algorithm based on thousands of sample tests interprets the result — which displays as a colored line, as with a pregnancy test — using the phone’s camera.

Gauss and Cellex, which manufactures the Gauss tests, await FDA authorization. In the meantime, they have produced more than 1.5 million kits and struck deals with supermarket chain Kroger and e-pharmacy site Truepill to sell them for about $30.

"A huge part of the accuracy issue with rapid tests is that you have to visually interpret them," Satish said. "Sometimes you get really faint lines, just like with a pregnancy strip, and there’s some guesswork."

Lucira Health, based in Emeryville, California, uses something called loop-mediated isothermal amplification technology, which is similar to PCR tests in precision. In February, the company went public, raising $153 million largely to fund the manufacturing of its all-in-one testing kit, currently prescribed by doctors across the country. The kit comes with a nose swab and a vial of chemicals analyzed by a hand-held device — taking up to 30 minutes for results.

Kelly Lewis Brezoczky, Lucira’s executive vice president, envisions the test kit on the shelf in local pharmacies, perched next to the NyQuil. "I always like to tell people that it is as easy to use as toothpaste," she said.

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