Health
As Lyme disease tests miss many acute infections, potential at-home test offers hope for earlier diagnosis
When Americans spend time in the great outdoors this summer, they don’t want to come back home with any uninvited guests.
Lyme disease, the most common tick-borne disease in the United States, can have severe complications if left untreated or unnoticed.
Prompt treatment is essential to prevent the spread of the disease elsewhere in the body.
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Yet the current recommended laboratory test to diagnose Lyme disease misses many early cases.
Now, a Virginia Tech research team is developing a promising at-home test that can diagnose the illness within hours of transmission, according to a recent report.
This undated photo provided by the Centers for Disease Control and Prevention (CDC) shows a blacklegged tick, also known as a deer tick. Officials said ticks would be more active than usual early in spring 2023, which means Lyme disease and other tick-borne infections could spread earlier and in greater numbers than in a typical year. Ticks can transmit multiple diseases that sicken humans, and deer ticks, which spread Lyme, are a fact of life in the warm months in New England and the Midwest. (CDC via AP/File)
Lyme disease is caused by a bacterium known as Borrelia burgdorferi and rarely, borrelia mayonii, which is transmitted to humans after an infected blacklegged tick bites them, per the Centers for Disease Control and Prevention (CDC).
“The only FDA-approved diagnostic for Lyme disease measures antibodies against Borrelia burgdorferi, not the presence of the bacterium itself,” Linda Giampa, executive director of the Bay Area Lyme Foundation in San Francisco, California, told Fox News Digital.
“Lyme disease has been commonly misdiagnosed by unreliable tests for far too long.”
“It misses up to 60% of acute cases of Lyme, as it takes several weeks for these antibodies to rise to detectable levels in people,” she added.
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“Lyme disease has been commonly misdiagnosed by unreliable tests for far too long, and there are currently no reputable at-home tests on the market,” she also said.
Symptoms may mimic the flu
Some 35,000 cases of Lyme disease are reported to the CDC every year, but the number of cases is grossly underreported — with insurance records estimating the true annual number around 476,000, according to experts.
The infection was named where it was first discovered: Lyme, Connecticut.
The CDC says people may experience symptoms that could mimic the flu — such as fever, chills, muscle and joint aches — within several days to one month after they’re bitten by a tick. (Elijah Nouvelage/Bloomberg via Getty Images)
Within several days to one month after a tick bite, someone may experience symptoms that could mimic the flu, such as fever, chills, muscle and joint aches, per the CDC.
In 70-80% of cases, a classically non-itchy rash that resembles a “bull’s-eye” develops at the site of the bite, often within a week of the infection, the agency added.
Prompt treatment helps decrease signs and symptoms of the disease and prevents spread to later stages of illness.
In later stages of the disease, such as days to months after the tick bite, untreated Lyme disease can spread to other parts of the body in about 60% of the patients.
Prompt treatment helps decrease signs and symptoms of the disease and prevents spread to later stages of illness.
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Diagnosis relies on the body’s immune response to the Lyme bacteria because it’s very difficult to culture the bacteria directly in lab.
A tick is shown running over a hand in June 2021. (Bernd Weissbrod/picture alliance via Getty Images)
“This requires both a healthy immune system and time to produce a robust enough response that can be detected (i.e., anti-B. burgdorferi titer),” Dr. Brandon Jutras, associate professor in the department of biochemistry and a member of the Fralin Life Sciences Institute at Virginia Tech in Blacksburg, Virginia, told Fox News Digital via email.
At-home test directly detects bacteria
Last year, the U.S. Department of Health and Human Services, in partnership with the Steven and Alexandra Cohen Foundation, a nonprofit to advance research of Lyme disease, initiated a competition known as the LymeX Diagnostics Prize.
The Jutras team at Virginia Tech is focusing on a component in the cell wall that’s unique to the bacteria that cause the disease.
The goal was to inspire researchers to develop better diagnostic tests to detect active Lyme disease infections in people more accurately.
There are 10 teams competing in the second round, including the team at Virginia Tech.
The goal of the competition known as the LymeX Diagnostics Prize is to inspire researchers to develop better diagnostic tests to detect active Lyme disease infections in people more accurately. The group at Virginia Tech is working on an at-home test that could enable “direct detection” of Lyme disease within just hours of transmission. (iStock)
“Among the promising diagnostics supported by the LymeX Diagnostics Prize are at-home tests, which are being developed by a research group at Virginia Tech to enable direct detection of the Lyme disease bacterium within hours of transmission,” Giampa noted.
The Jutras team is focusing on a component in the cell wall that’s unique to the bacteria that cause the disease.
There are hopes the team’s work “will lead to a rapid, specific test that doesn’t rely on a patient response.”
“Virtually all bacteria have layer(s) of peptidoglycan, and many of the components that make up peptidoglycan are highly similar,” Jutras told Fox News Digital.
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“As it turns out, the peptidoglycan from the bacterium that causes Lyme disease is vastly different.”
As the bacteria grow, they shed these unique pieces of their peptidoglycan that are highly abundant — which makes it a “perfect biomarker for diagnostics,” he added.
A close-up of an adult female, an adult male, nymph and larva tick are shown here. Ticks can cause Lyme disease, an acute inflammatory disease characterized by skin changes, joint inflammation and flu-like symptoms. (Getty Images)
“We have created several monoclonal antibodies that are capable of specifically detecting the peptidoglycan pieces,” he said.
Antibodies to the Lyme bacteria can linger for months, he said.
So it’s not always clear from the current recommended testing available if the patient has an active infection — or was infected in the past.
Although it will be likely several years before his test may be ready for use, “our approach would, in theory, work immediately after transmission because as long as the bacterium is replicating, [it is] shedding peptidoglycan,” he said.
It will be likely several years before this test may be ready for use.
“This is a basic feature of this unusual organism,” he added.
“Our test exploits this process,” he said — noting that he hopes it “will lead to a rapid, specific test that doesn’t rely on a patient response.”
LymeX Diagnostic Prize officials note on the competition’s website, “As the geographic range of ticks, mosquitoes, and fleas that can transmit pathogens and cause disease expands within the United States, the need for diagnostic innovation will only become more urgent.”
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Jutras also said, as noted on that site, that he hopes long term, “we can do exactly what happened with COVID-19 and turn it into an at-home test. You wouldn’t be able to do a blood test; that’s not safe. But where we would optimize this is the urine test.”
Since the age of 13, Joseph Kowalsky has harbored a fascination with life after death, pondering ways to extend his existence indefinitely.
Today, Kowalsky, now 59, is among some 2,000 individuals who have signed up with the Cryonics Institute in Clinton Township, Michigan, betting on a future where death is not the end.
Chilling prospect of immortality
Cryonics, the process at the heart of Kowalsky’s hopes, involves preserving human bodies at ultra-low temperatures in the anticipation that future science will one day revive them.
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Shortly after a person dies, organizations like the Cryonics Institute use a heart-lung resuscitator, circulate a medical-grade antifreeze in the blood and suspend the body in aluminum pods filled with liquid nitrogen.
Dennis Kowalski, current president of the Cryonics Institute (and no relation to Joseph Kowalsky), told Fox News that over 250 individuals are currently in “suspension” at the Michigan facility.
Cryonics involves preserving human bodies at ultra-low temperatures in the anticipation that future science will one day revive them. (Cryonics Institute)
Could defying death be affordable?
The Cryonics Institute is just one player in a burgeoning industry.
Alcor, the world’s oldest cryonics company, which is based in Scottsdale, Arizona, boasts a state-of-the-art facility where more than 200 individuals are preserved.
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For those opting for whole-body preservation, the price tag is $200,000, while brain-only preservation costs $80,000.
Alcor CEO James Arrowood dispels the notion that cryonics is solely for the wealthy, highlighting that many clients use life insurance policies to cover costs.
Over 250 individuals are currently in “suspension” at the Michigan facility, the president of the Cryonics Institute told Fox News. (Cryonics Institute)
“About 80% of people who sign up are middle-class,” Arrowood told Fox News.
He pointed out that the clientele includes notable figures such as baseball legend Ted Williams, whose head and body were cryopreserved separately.
Skeptics cast doubt
Critics dismiss cryonics as speculative and unproven, labeling it an “iceberg scheme” lacking scientific backing.
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“It’s a sad case of people being beguiled by a very understandable dream of resurrection,” Clive Coen of King’s College London told Fox News.
The neuroscience professor raised concerns over the damage inflicted during the preservation and revival process, warning that “there will be billions of mini-strokes in every millimeter of brain tissue” due to the inability of antifreeze to traverse the brain’s complex landscape.
Hope springs eternal for death defiers
There is currently no scientific evidence or successful case of a human being revived from a cryonically preserved state.
For those opting for whole-body preservation, the price tag is $200,000, while brain-only preservation costs $80,000. (Cryonics Institute)
Despite the skepticism, Joseph Kowalsky, who formerly worked with the Cryonics Institute, remains undeterred.
“Worst-case scenario, I’m still dead … And the upside? It could be a potentially life-saving medical technique,” he said.
For more Health articles, visit www.foxnews/health
As science and ethics continue to grapple with the implications of cryonics, individuals like Kowalsky illustrate a deep-seated hope for defying mortality, one frozen body at a time.
Andres del Aguila and Griff Jenkins contributed to this report.
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Most of the 38 million people living with diabetes in the U.S. use daily injections or insulin pumps to keep glucose at safe levels — but new research suggests that a third option could be just as effective.
In a study led by Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, an inhaled form of insulin — similar to an asthma inhaler — worked just as well as injections or pumps to control type 1 diabetes.
The research was presented last week at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, Florida.
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The clinical trial tested a product called Afrezza, an inhaled insulin made by MannKind Corporation in California.
Afrezza, the only inhaled insulin on the market, has been available since getting FDA approval in June 2014.
An inhaled form of insulin worked just as well as injections or pumps to control type 1 diabetes in a recent study. (iStock/MannKind)
Benefits of a third option
“In those with type 1 diabetes, insulin is required for survival,” Hirsch told Fox News Digital in an interview.
“With continuous glucose sensing, glucose control has been dramatically improved — but not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” he said.
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With pumps, people must wear the device, which can lead to skin problems.
They also have to purchase extra accessories.
Blood glucose levels can also drop with exercise, Hirsch warned, which can be problematic.
Afrezza, an inhaled insulin pictured here, is made by MannKind Corporation in California. (MannKind)
“Injections overall can be more convenient for some, but they don’t do as well as pump patients,” he said.
With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, Hirsch noted.
“Patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice.”
During the 17-week study, researchers evaluated the results of 141 adults who were assigned to either use the Afrezza inhaler or continue with traditional methods of injection or pump delivery.
At the 17-week mark, all participants switched to the inhaler for another 13 weeks.
Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, led the new study. (MannKind)
All groups were assessed with continuous glucose monitoring at the start of the study, at 17 weeks and again at 30 weeks.
Among the inhaled insulin group, 30% of participants reached their target glucose levels (less than 7% blood sugar) compared to 17% of the people using injections and pumps.
There was no difference in hypoglycemia (low blood sugar) between the groups.
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“In general, there was no difference in our primary endpoint, HbA1c, a reflection of average blood sugar,” Hirsch said.
“But that alone is misleading — many patients did better with their glucose control, while others did worse.”
With Afrezza, the product is inhaled into the lungs before meals, and the fast-acting insulin minimizes the glucose spike often seen after eating, a doctor said. (MannKind)
“The point is, inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”
The people who saw the best results inhaled insulin between meals and at bedtime, Hirsch added.
At the end of the study, more than half of the participants said they would opt to stay on the inhaled insulin therapy.
“The biggest takeaway is that patients with type 1 diabetes should consider this as another option for their mealtime insulin, and talk to their doctor about this choice,” he recommended.
‘Adds value’
The American Diabetes Association acknowledged the promise of the study findings in an email to Fox News Digital.
“We look forward to our Scientific Sessions every year to see data like the INHALE-3 study’s findings, which have the potential to expand diabetes care,” Raveendhara Bannuru, M.D., PhD, the ADA’s vice president of medical affairs and quality improvement outcomes in Boston, Massachusetts, told Fox News Digital via email.
“With continuous glucose sensing, glucose control has been dramatically improved,” a doctor told Fox News Digital. (iStock)
“We are hopeful for the continuous development of alternative insulin delivery methods that could offer options for people living with diabetes,” the group also said in the statement.
“The INHALE-3 trial demonstrated that inhaled insulin, combined with insulin degludec, effectively reduces A1c levels without increasing hypoglycemia or weight gain in people with type 1 diabetes. This adds value to the options in insulin therapy.”
Potential risks and limitations
While more people met their glycemic targets with Afrezza, some subjects saw worse readings when switching from usual methods to inhaled insulin — “potentially due to missing doses of inhaled insulin during the day and/or underdosing going into bedtime,” the researchers wrote.
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“We didn’t see any concerns,” Hirsch said when asked about side effects.
“As expected, a few people coughed immediately when dosing their insulin, but no major concerns were seen and everyone continued on their inhaled insulin.”
“Not everyone reaches the target with multiple injections or pumps, and there are many pros and cons with each therapy,” a doctor said. (iStock)
The most common side effects noted in the study were hypoglycemia, cough and throat pain or irritation.
Afrezza has been linked to a risk of acute bronchospasm in patients with chronic lung disease, such as asthma or COPD, according to the manufacturer.
“Inhaling insulin isn’t for everyone, but some did better than they did on their pumps.”
Before starting Afrezza, patients should see a doctor for a physical examination and testing to measure lung function.
Patients who smoke or who recently quit smoking should not take the inhaled medication.
For more Health articles, visit www.foxnews/health
Fox News Digital reached out to MannKind requesting additional comment.
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