FDA approves blood test to detect colon cancer for those at ‘average risk’
(NEW YORK) — The U.S. Food and Drug Administration on Monday morning approved a blood test to screen for colorectal cancer in certain individuals.
The blood test, known as Shield and manufactured by Guardant Health, is already commercially available, but FDA approval will help broaden availability and insurance coverage.
The test was approved for people aged 45 and older with an “average risk” of colon cancer.
Specialists warn that the blood test is not an equivalent alternative to colonoscopies, but it could lead to more people getting screened since it takes less time and effort to get screened. Colonoscopies are more accurate at detecting cancer, allow for the removal of precancerous polyps, and are recommended every 10 years instead of every three years for the blood test.
The false positive rate of the Shield test is about 10%, and it only found 13% of large polyps as compared to 95% with a colonoscopy in a clinical trial.
Shield detects colorectal cancer by detecting DNA shed by tumors in blood samples. Results take about two weeks after the samples are received by the laboratory.
Shield is not the first blood-based screening tool available for colorectal cancer, and colonoscopies are still considered the gold standard for screening.
However, the test presents another option to screen for a type of cancer that has been affecting many Americans at younger ages than before.
Earlier this year, an FDA advisory panel — the Medical Devices Advisory Committee (MDAC) — recommended that the federal health agency approve the test. Although FDA approval isn’t guaranteed, the agency usually agrees with its advisers.
Despite the high overall sensitivity rate, the clinical trial data indicated Shield may miss one in 10 people who have precancerous lesions and one in 1,000 people with cancerous lesions.
These “false negatives” may result in tests finding no evidence of cancer, but patients actually have precancerous or cancerous lesions, according to the clinical trial data.
Although members of the MDAC did express concerns about false negatives, the committee ultimately found the test to be safe and effective and that the benefits of use outweighed potential risks.
“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” AmirAli Talasaz, Guardant Health co-CEO, said in a press release.
“We are now getting ready to launch this test in the near future and are very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients,” Talasaz said.
(NEW YORK) — Cases of whooping cough are more than three times higher this year than they were at the same time last year, according to data from the Centers for Disease Control and Prevention (CDC).
So far this year, there have been 10,865 recorded cases of whooping cough, or pertussis, compared to the 2,918 recorded during the same time in 2023, CDC data shows.
The number of cases is closer to the 8,271 cases of whooping cough recorded this time in 2019, indicating a return to pre-pandemic levels.
Doctors said that reported cases of whooping cough were lower than usual over the past few years, likely due to COVID-19 mitigation measures including masking, remote learning and social distancing.
“During the pandemic itself, we really had a low point in transmission of pertussis, and that was just because of all of the social distancing and isolation,” Dr. Mike Patrick, an emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio, told ABC News. “If kids aren’t around each other, and also around adults, then they’re not able to pick up the disease, since it’s an infectious disease and transmitted from one person to another.”
“So, I think, we’re just getting back up there because people are back doing the normal things that we do, and that’s just the pattern that we see with the vaccine that we have. But I will say, without the vaccine, we’d see a whole lot more pertussis than 10,000 cases,” he added.
Dr. Lori Handy, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said the uptick in cases of whooping cough post-pandemic is similar to those seen in the U.S. with other diseases as mitigation measures started to disappear.
“I honestly think it was a little surprising that it took this long, recognizing we lifted [many] measures close to two years ago,” she told ABC News. “I think many folks remember the increase in RSV cases that we saw back in 2022, so this has lagged behind some other respiratory infections, but definitely now has resurfaced and looks very typical to 2019.”
Whooping cough is a very contagious respiratory illness caused by a type of bacteria called Bordetella pertussis.
These bacteria attach to the cilia — the tiny, hair-like structures found on the surface of some cells –of the upper respiratory system that help clear mucous and other debris in the airway, and release toxins. The toxins damage the cilia and cause the upper airways to swell, according to the CDC.
“You get airway swelling and a terrible, terrible cough because the cilia aren’t working, and so your body resorts to coughing to try to keep stuff out of the lungs and to bring things up,” Patrick said. “Oftentimes, babies will have a little bit difficulty breathing. They’re having the cough…and then they take a big, deep breath, because they hadn’t breathed during all those coughs, and that’s why it’s called whooping cough, because that’s the [sound] when they’re coughing.”
Whooping cough is spread from person-to-person through coughing and sneezing. Infected people can be contagious for weeks without knowing they have whooping cough.
Early symptoms often resemble a common cold — runny nose, cough and low-grade fever — and typically last for one to two weeks. Symptoms, however, can progress to rapid, violent coughing fits that can last up to 12 weeks.
Whooping cough can be treated with antibiotics and receiving treatment early can reduce the severity of the infection. Most whooping cough symptoms can be managed at home, according to the CDC.
Although anyone can contract pertussis, infants under age one, pregnant women and immunocompromised people are at highest risk for severe illness.
“In the younger kids, and especially in infants, they can have apnea, so they stop breathing. They can be hospitalized in the intensive care unit, and unfortunately, children can and have died from pertussis,” Dr. Robert Frenck, a professor of pediatrics in the division of infectious diseases at Cincinnati Children’s Hospital in Ohio, told ABC News. “So, these are not innocuous infections. They can be very serious, and they can be deadly.”
A vaccine for whooping cough was introduced in the late 1940s and the number of cases each year has since dropped dramatically, decreasing more than 90% compared to the pre-vaccine era.
Before the vaccine, there were an estimated 200,000 cases annually among children and up to 9,000 children died, according to the CDC.
There are two types of vaccines currently used to protect against whooping cough: diphtheria, tetanus, and pertussis (DTaP) vaccine for babies and children younger age 7 and tetanus, diphtheria, and pertussis (Tdap) vaccines for older children, adults and pregnant women.
A recent report from the CDC found that exemptions for routine childhood vaccination among kindergartners during the 2022-23 school year were at the highest level ever, including for the DTaP vaccine. Frenck said the increase in whooping cough cases are a reminder that vaccines are effective, but said he doesn’t discourage vaccine-hesitant patents from asking questions.
“Parents want to do what’s best for their children, and so they want to keep their children healthy,” he said. “Unfortunately, there has been a fair amount of misinformation about vaccines to where people are confused. So, my recommendation really is to talk with your health care provider, ask your questions, get your answers, feel comfortable about having your children vaccinated. Vaccines are well-tested, vaccines are safe, vaccines are protective.”
Handy said she also encourages everybody who is eligible to get vaccinated and for health care providers to be on the lookout for pertussis cases
“For health care providers … recognize this is back, like five years ago, and the only way we will detect it is by testing it and then using our public health measures to prevent spread,” she said.
(NEW YORK) — As mosquito season continues, public health officials in the U.S. have been tracking several different illnesses caused by the pesky flying insect.
Health officials are reporting at least eighteen deaths from West Nile virus in the U.S. this year, with three recent deaths recorded in Wisconsin and Illinois. There have been six cases of eastern equine encephalitis (EEE), including one person who died after testing positive for the virus, as well as dengue cases recorded in several states. The viruses that cause all three illnesses are transmitted to humans via mosquito bite.
“What we’ve seen is a rapid uptake in certain viruses that haven’t been in the limelight in recent years. Both West Nile virus and ‘triple E,’ which is eastern equine encephalitis, have had an uptick, particularly post-COVID,” Dr. Larry Han, an assistant professor of public health and health sciences at Northeastern University in Boston, told ABC News.
“There’s also been a rise in dengue relative to what we’ve seen in recent years. And so, these ‘triple threats,’ you might say, have led to more attention and more worry among the general populace.”
Experts who spoke with ABC News said some of the uptick is due to the “randomness” regarding which seasons have a greater number of cases than others, coupled with the general rise in mosquito-borne viruses during the summer and early fall months.
Here are some ways to tell the difference between West Nile, EEE, and dengue. However, if you’re concerned you might have contracted any of these viruses, you should contact your doctor immediately.
How common are West Nile, EEE and dengue?
West Nile virus is the leading cause of mosquito-borne disease in the contiguous United States, according to the Centers for Disease Control and Prevention (CDC). It was first identified in the Western Hemisphere in August 1999 after people were diagnosed in New York City.
Dengue viruses are spread through bites from infected Aedes species mosquitoes, mostly found in tropical and subtropical regions of the world, according to the CDC. These mosquitoes are also responsible for spreading Zika and chikungunya viruses.
“It would be very rare to see dengue cases unless you lived in more tropical climates, so you might see this in Florida, some Southern states along the East Coast, but, for example, you would nearly never see this in Massachusetts or in the Midwest or West,” Han said.
Comparatively, EEE is quite rare, with only a few cases reported in the U.S. every year. However, similar to dengue, most cases occur in the Eastern or Gulf Coast states, according to the CDC.
What are the symptoms?
The majority of people with West Nile virus do not present with symptoms, but about one in five will experience fever along with headaches, body aches, joint pain, diarrhea, vomiting, or a rash. Symptoms typically disappear in a week or less for most people but weakness and fatigue may last for weeks or months. For some people, however, the disease can progress to something far more concerning.
“About one out of 150 of those people that develop signs and symptoms can actually develop a more severe disease, like West Nile encephalitis, where we have the swelling of the brain that could potentially be fatal,” Dr. Thomas Duszynski, director of epidemiology education at the Indiana University Richard M. Fairbanks School of Public Health, told ABC News.
Similarly, about one in four people who contract dengue develop symptoms lasting two to seven days, but symptoms are usually mild and may include fever, rash, nausea, vomiting, muscle pain, joint pain and bone pain.
Duszynski explained that most U.S. dengue cases are typically seen among people who contract it while traveling abroad, where dengue is endemic or where cases are more common, and who then bring the virus back to the U.S. Because dengue’s symptoms are not specific to the virus, they’re often confused with other illnesses, according to the CDC.
Most people who are infected with EEE show either mild symptoms or no symptoms at all, according to the CDC. However, severe cases typically present with fever, headache, chills and vomiting.
Like West Nile virus, EEE also can progress to a more severe condition, like encephalitis or meningitis, the latter of which is swelling of the membranes that surround the brain and spinal cord. Many survivors can experience ongoing neurologic problems, including convulsions, paralysis and intellectual disability. About 30% of encephalitis cases caused by EEE result in death.
“I think the mortality risk if one were to contract dengue or West Nile virus would be very low. For EEE, it’s the opposite; it’s very high,” Han said.
Treatments and vaccines
There are no disease-specific treatments for any of the viruses. The CDC recommends rest, fluids, and over-the-counter medications to relieve symptoms. Patients with severe illness often need to be hospitalized and receive additional supportive treatments, such as intravenous fluids.
There also are no vaccines available for West Nile or EEE. However, a dengue vaccine is available in the U.S. and is FDA approved for children between ages 9 and 16 who have a laboratory-confirmed previous dengue virus infection and who live in areas where dengue is endemic.
The vaccine also is available in Puerto Rico and is part of the territory’s routine childhood immunization schedule, the CDC said.
Dengue can be caused by dengue virus strains 1, 2, 3 or 4, with a person being infected multiple times over the course of their life, Duszynski told ABC News, so a vaccine may be able to help prevent infection from a different strain.
“If I got infected with one strain, if I get bit by this mosquito with the same strain, I’m probably going to be okay,’ he said. “But it’s those three other strains that are out there that … I could get infected with even though I had strain 1.”
How to best protect yourself from infection
There are no differences when it comes to protecting yourself from dengue, EEE or West Nile virus, the experts told ABC News. Prevention methods include using effective mosquito repellents, wearing long-sleeve shirts and long pants when outside, and staying in places with air conditioning, when possible. The CDC also recommends emptying containers of still or stagnant water, to eliminate places where mosquitos can breed.
“The single deadliest [animal] to the human species has been the mosquito,” Han said. “So, while we might think of sharks or we might think of lions or tigers, it’s really the mosquito that has led to the devastation of the human population multiple times throughout history.”
“I’m not saying that we should kill off all mosquitoes, because they play an important role in ecology, but there are various new techniques and strategies people are thinking about to combat mosquito-borne viruses and illnesses,” Han continued. “I’m hopeful that we can make mosquito borne viruses less of a threat to humanity.”
(COLUMBUS, Ohio) — A judge on Friday temporarily blocked parts of Ohio’s six-week abortion ban.
The Franklin County Court of Common Pleas put a hold on several laws that force abortion patients to wait a minimum of 24 hours after receiving state-mandated information in person before accessing abortion care.
According to the ACLU of Ohio, this is the first ruling on the merits of a ballot measure that amended the Ohio constitution to establish “an individual right to one’s own reproductive medical treatment, including but not limited to abortion.”
Much of the ban was rendered unconstitutional after the amendment went into effect in December 2023, Ohio’s Attorney General Dave Yost, said earlier this year.
Judge David C. Young ruled that the ban’s requirements do not advance patient health and violate the reproductive rights guaranteed by the amendment.
“This is a historic victory for abortion patients and for all Ohio voters who voiced support for the constitutional amendment to protect reproductive freedom and bodily autonomy,” Jessie Hill, cooperating attorney for the ACLU of Ohio. “It’s clear that the newly amended Ohio Constitution works as the voters intend: to protect the fundamental right to abortion and to forbid the state from infringing on it except when necessary to protect the health of a pregnant person.”
The statement continued, “This decision is the first step in removing unnecessary barriers to care. We celebrate this ruling and will push forward to make this injunction permanent.”
In a statement, Bethany McCorkle, the attorney general’s communications director, said the office would be appealing the ruling.
“We have heard the voices of the people and recognize that reproductive rights are now protected in our Constitution,” McCorkle’s statement read. “However, we respectfully disagree with the court’s decision that requiring doctors to obtain informed consent and wait 24 hours prior to an abortion constitute a burden. These are essential safety features designed to ensure that women receive proper care and make voluntary decisions.”
Abortions are now banned at 22 weeks’ gestation or later, according to the Guttmacher Institute, a research group that studies sexual and reproductive rights.
However, lawmakers have tried to maintain other parts of the ban, including reporting requirements and a 24-hour waiting period before an abortion can be administered. Those are challenges that abortion rights supporters say often prevent patients from receiving the procedure at all.
The so-called “heartbeat bill” was signed into law in 2019 by Gov. Mike DeWine and prevents abortions from performed once fetal cardiac activity can be defected, which typically occurs at about six weeks’ gestation — before many women know they’re pregnant.
The ban has no exceptions for rape or incest. The only exceptions are cases of ectopic pregnancies and to prevent the mother’s death or impairment of a major bodily function.
A federal judge blocked the ban in 2019 but it was reinstated just hours after the Supreme Court decision to overturn Roe.
In September 2022, an Ohio lower court granted a temporary restraining order before granting a preliminary injunction a few weeks later. In December 2023, the state’s Supreme Court dismissed the state’s appeal and sent the case back to the lower courts.
Since the Supreme Court overturned Roe v. Wade in June 2022, 14 states have ceased nearly all abortion services, according to an ABC News tally, while three states — Florida, Georgia and South Carolina — all have six-week bans in place.
Following the court’s decision, six states aside from Ohio have had abortion-related questions on the ballot and, each time, voters have sided with abortion rights supporters
In an August 2022 primary, Kansas became the first state to let voters decide on abortion since the Supreme Court’s ruling, and residents struck down a proposal to remove the right to abortion from the state’s constitution.
Three states — California, Michigan and Vermont — voted to strengthen rights and two states — Kentucky and Montana – voted against further limiting rights.
It’s unclear how many states will have abortion-related ballot questions in the November 2024 election but, so far, 10 states have abortion-related state constitutional amendments on the ballot, according to KFF.