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Saturday, February 25, 2023
FDA approves first at-home test to detect both flu and COVID
February 25, 2023
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People will soon be able to self-test for both flu and COVID-19 in one fell swoop — without leaving their homes.
The Food and Drug Administration (FDA) has authorized the first over-the-counter (OTC) home test that can detect both influenza A and B as well as SARS-CoV-2, the virus that causes COVID-19.
Using samples from a nasal swab, the Lucira COVID-19 & Flu Home Test provides results in around half an hour, the FDA said.
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The single-use test does not require a doctor’s prescription.
"Today’s authorization of the first OTC test that can detect influenza A and B, along with SARS-CoV-2, is a major milestone in bringing greater consumer access to diagnostic tests that can be performed entirely at home," said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, in a press release on the FDA's website.
"The FDA strongly supports innovation in test development, and we are eager to continue advancing greater access to at-home infectious disease testing to best support public health needs," he went on.
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"We remain committed to working with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them."
People 14 and older can collect their own nasal swab samples.
Adults will also be able to take samples from kids 2 and older.
The FDA recommends that those who test positive contact their doctor to report the results and receive follow-up care.
When testing people who had symptoms of respiratory infection, the Lucira COVID-19 & Flu Home Test showed 90.1% accuracy for detecting positive influenza A cases and 99.3% for negatives.
The test detected 88.3% of positive COVID-19 cases and 100% of negatives.
It also detected 99.9% of negative influenza B.
Further samples are needed to calculate the accuracy of positive influenza B cases, as there were not enough public cases at the time of testing.
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"The availability of home influenza and COVID-19 testing is a welcome advance," Dr. George Thompson, infectious diseases specialist at UCDavis Health Medical Center in Sacramento, California, told Fox News Digital via email.
"I am hopeful this will decrease the transmission of both viruses, as our patients can receive an accurate and timely diagnosis as to the cause of their symptoms."
Dr. Timothy Brewer, professor of medicine and epidemiology at UCLA in Los Angeles, California, said the home test is good news for consumers.
"We have antiviral treatments for both influenza and COVID-19," he said in an email to Fox News Digital.
He said he hoped that "individuals who test positive will reach out to their health care providers to see if they need a confirmatory test and treatment."
Regardless of the result of the home test, Dr. Brewer said that anyone with flu-like symptoms should isolate until they are feeling better and do not have a fever.
"In addition, if at any time a person has trouble breathing, [has] confusion or is not getting better, they should seek immediate medical attention regardless of whether they had a positive or negative test result."
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The Centers for Disease Control and Prevention (CDC) states on its website that positive home COVID tests are highly reliable, but false negatives are possible.
Those who receive a negative result but still have symptoms of cold or flu should seek follow-up care from a doctor.
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Friday, February 24, 2023
CDC advisory group finds insufficient evidence to recommend more than one COVID-19 booster a year
February 24, 2023
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A US Centers for Disease Control and Prevention (CDC) advisory group said Friday it isn’t recommending more than one annual coronavirus vaccine booster.
The working committee, which is part of the CDC’s Advisory Committee For Immunization Practices, found insufficient evidence that more than one shot a year would benefit older or immunocompromised people.
Annual shots are recommended by the CDC as the vaccine’s effectiveness diminishes over time, especially in more vulnerable populations - the shot generally wanes faster in older people compared ot younger adults - and the group said it recommends an annual booster campaign that would likely start later this year.
The Food and Drug Administration (FDA) outlined a plan for a yearly shot last month but an FDA committee said it wasn’t sure if yearly vaccines were the right move because there are still so may unknowns about the virus.
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The Administration’s Vaccine and Related Biology Products Advisory Committee stressed that COVID-19 is not exactly like the flu, which is more seasonal regarding surges in infections.
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"We may or may not need annual vaccination," Dr. Cody Meissner, a Tufts University School of Medicine pediatrician, said, according to NBC News. "It’s just awfully early, it seems to me, in this process to answer that."
Earlier this month, the CDC added the COVID-19 vaccine to the child and adolescent immunization schedule.
The schedule, which is posted on the CDC's website, recommends that children between six months and 18 years old should receive two doses of the primary series between four and eight weeks apart — followed by a booster dose at least eight weeks later.
The schedule is a recommendation, not a requirement.
Children who are "moderately or severely immunocompromised" should include a third dose in the primary series, says the CDC.
Reuters and Fox News' Melissa Rudy contributed to this report.
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Could a urine test detect pancreatic and prostate cancer? Study shows 99% success rate
February 24, 2023
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A simple urine test could detect pancreatic and prostate cancer with up to a 99% rate of accuracy, says a team of researchers from the Surface & Nano Materials Division of the Korea Institute of Materials Science.
Dr. Ho Sang Jung, lead author of the study, said cancer urine contains cancer metabolites and is different from normal urine.
The study, recently published in the journal Biosensors and Bioelectronics, aimed to determine whether urine tests could detect those cancer metabolites, which are released by cancer cells to promote tumor growth.
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After the urine sample was placed on a test strip, the researchers used a special type of light scattering technique that generated a "fingerprint spectrum of chemicals," which detected the cancer metabolites.
Dr. Jung said the tests can detect cancer at various stages.
"The purpose of developing this kind of technology is to screen the cancer patient before they go to the hospital," he told Fox News Digital in an email.
"We are not sure that the test strip can differentiate cancer at very early stages, but at least it can suggest the possibility of cancer status — so the patient may then go to the hospital for a precise medical checkup."
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Dr. James Anaissie, a urologist with Memorial Hermann in Houston, Texas, who was not involved in the study, is optimistic about the future of this technology — but he’s not jumping completely on board just yet.
"If the test is as reliable as they say it is, it may have an important role in screening, as the current PSA [prostate-specific antigen] blood test we use is notoriously unreliable," he told Fox News Digital in an email.
"There is a big need for something like this."
Also, from a clinical perspective, urine testing is much easier than blood testing, the doctor said.
However, Anaissie remains a bit skeptical.
"Although they report excellent sensitivity and specificity for prostate cancer, the data to support this is only available upon request of the research team, and they have almost no tables demonstrating these findings, which I would consider standard for studies of this nature," he said.
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"For example, were the patients diagnosed with prostate cancer in severe stages, where it’s obvious they have prostate cancer even without any urine tests?" said Dr. Anaissie.
"Was it just as accurate for low-grade and high-grade cancers? Whenever I hear about exciting new technology, I’m always receptive, but with a raised eyebrow."
Urine screenings can be used by anyone, said Dr. Jung. The end goal is for this type of technology to be available for at-home testing.
He foresees several possible practical uses, including screening for cancer before going to the hospital, monitoring for cancer recurrence after treatment, or supplementary testing in addition to blood work.
The study authors recognize some limitations of the research.
"It was hard to get enough urine samples from cancer patients," said Dr. Jung.
His team used 100 samples in the study and is continuously collecting more from hospitals throughout Korea.
Also, because this is a new technology, it still has not been approved by the Ministry of Food and Drug Safety in Korea for commercial use.
Anaissie also points out that more studies are needed to see if the test works when there is a urinary tract infection or blood in the urine, which is not uncommon in patients with prostate cancer.
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"Technology like this takes a long time to go from the lab’s proof of concept to everyday use, and a lot of people are going to try to pick it apart to make sure it’s safe and reliable," Anaissie said.
"The last thing you want is a screening test that ends up having a lot of false negatives. If it can survive the scrutiny, then it has the potential to revolutionize prostate cancer screening."
The researchers’ ultimate goal is for the urine screenings to extend eventually to other types of cancers, such as lung cancer and colorectal cancer.
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"We are currently developing a system that can classify four cancer types — pancreatic cancer, prostate cancer, lung cancer and colorectal cancer — simultaneously," Jung told Fox News Digital.
He expects the follow-up study to be published sometime this year.
Pancreatic cancer makes up around 3% of cancer diagnoses in the U.S. and 7% of deaths, per the American Cancer Society (ACS).
Men are slightly more susceptible than women.
Prostate cancer is the most common type of cancer among American men, with about one in 41 dying of the disease (via the ACS).
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Laxatives taken on consistent basis could increase dementia risk, new study finds
February 24, 2023
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Older adults who take laxatives on a regular basis could face a 51% higher risk of developing dementia compared to those who do not use them, a new study published in the journal Neurology suggests.
However, there are caveats to the study.
Titled "Association Between Regular Laxative Use and Incident Dementia in UK Biobank Participants," the study was conducted at the UK Biobank.
It's a "large-scale biomedical database and research resource containing in-depth genetic and health information from half a million U.K. participants," according to the study.
Researchers from the University of Cambridge, Harvard Medical School and other universities looked at 502,229 participants between the ages of 40 and 69 (with an average age of 56.5) who had no history of dementia.
Among those who said they took laxatives "most days of the week" over the last four weeks, 1.3% had developed all-cause dementia or vascular dementia after a span of 9.8 years.
Only 0.4% of those who did not use laxatives had the same outcome.
Vascular dementia is a condition that causes "problems with reasoning, planning, judgment, memory and other thought processes caused by brain damage from impaired blood flow to your brain," as defined by the Mayo Clinic.
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The study found no association between laxative use and the development of Alzheimer’s disease, which makes up 60%-70% of all dementia cases, per the World Health Organization.
Two of the most common types of over-the-counter laxatives are osmotics and stimulants. Osmotic laxatives work by attracting water to hydrate and soften the stool, while stimulant laxatives trigger the bowel muscles to contract.
The study found that osmotic laxatives had the strongest association with dementia risk, with a 64% increase.
"Constipation and laxative use is common among middle-aged and older adults," said study author Feng Sha, PhD, of the Shenzhen Institute of Advanced Technology at the Chinese Academy of Sciences, in a press release from the American Academy of Neurology.
"However, regular laxative use may change the microbiome of the gut, possibly affecting nerve signaling from the gut to the brain or increasing the production of intestinal toxins that may affect the brain."
She went on, "Our research found regular use of over-the-counter laxatives was associated with a higher risk of dementia, particularly in people who used multiple laxative types or osmotic laxatives."
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Those who took multiple types of laxatives were found to have an even higher risk of dementia, with a 90% increase.
Researchers adjusted the results to account for lifestyle factors, pre-existing medical conditions, medications, family history and other socio-demographic attributes.
Dr. Laura Purdy, M.D., a board-certified family medicine physician in Nashville, Tennessee, said the study is very high-level and looks only broadly at the association between dementia and laxative use. She was not involved in the study.
"It shows that there is an increased risk of all-cause dementia, which means that any type of dementia seems to be increased in this patient population," she told Fox News Digital in an email.
"Much more information is needed, such as which laxatives may contribute, how much use is risky, and what, if any, clinical recommendations should or shouldn’t be made regarding laxative use."
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The researchers based their hypothesis on the "microbiome-gut-brain axis," which links the body’s intestinal functions with the brain’s cognitive centers.
Dr. Marc Siegel, professor of medicine at NYU Langone Medical Center in New York City and a Fox News medical contributor, believes the association between laxatives and all-cause dementia makes sense.
"There are electrolyte disturbances with chronic laxative use," he told Fox News Digital in an email.
"Also, laxatives can and do draw chemicals out of the gut (microbiome), which also work as neurotransmitters in the brain. There is a strong gut/brain connection that you don’t want to disrupt."
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Approximately four million people suffer from constipation in the U.S., the Johns Hopkins Medicine website says. The condition leads to 2.5 million doctor visits each year.
About one-third of older adults experience at least occasional constipation, the National Institute on Aging states on its website.
"More research is needed to further investigate the link our research found between laxatives and dementia," said Dr. Sha, per the press release.
"If our findings are confirmed, medical professionals could encourage people to treat constipation by making lifestyle changes such as drinking more water, increasing dietary fiber and adding more activity into their daily lives."
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