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.
(WASHINGTON) — Former New York Gov. Andrew Cuomo is set to publicly testify Tuesday before Congress on his administration’s nursing home policies during the early days of the COVID-19 pandemic.
The hearing, before the Republican-led House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic, will see Cuomo defend his decision to allow COVID-19-positive patients back into nursing homes and long-term care facilities while the pandemic was underway.
Cuomo previously testified before the subcommittee during a closed-door hearing in June. Transcripts from that interview, as well as with high-ranking officials during Cuomo’s administration, will be released ahead of the public hearing.
“Andrew Cuomo owes answers to the 15,000 families who lost loved ones in New York’s nursing homes during the COVID-19 pandemic,” subcommittee Chairman Rep. Brad Wenstrup, R-Ohio, said in a statement last week. “On September 10, Americans will have the opportunity to hear directly from the former governor about New York’s potentially fatal nursing home policies.”
In March 2020, as COVID-19 cases were surging, Cuomo issued an order requiring nursing homes to readmit all residents who were “medically stable” and returning after being hospitalized for the virus.
“No resident shall be denied re-admission or admission to the [nursing home] solely based on a confirmed or suspected diagnosis of COVID-19,” the order read.
It further stated that nursing homes were “prohibited from requiring a hospitalized resident who is determined medically stable to be tested for COVID-19 prior to admission or readmission.”
At the time, Cuomo explained that the order would help expand hospital capacity to meet the demands of caring for the sickest COVID-19 patients. After facing criticism from nursing home advocates, however, the governor amended the order in May 2020, prohibiting hospitals from discharging patients to nursing homes unless they first tested negative for COVID-19.
Cuomo fought back against criticism of his policies and, in July 2020, a report from the New York State Department of Health (NYSDOH) stated that COVID-19 was introduced into nursing homes by infected staff, and that peak staff infections correlated with peak nursing home resident deaths. The report also found that “admissions policies were not a significant factor in nursing home fatalities.”
However, in January 2021, New York Attorney General Letitia James released a report that found the NYSDOH had undercounted the number of nursing home residents who died of COVID-19 by as much as 50%, and failed to count in its official death tally nursing home residents who died of COVID-19 after being admitted to hospitals.
In 2022, Cuomo’s representative said the Manhattan District Attorney’s office would not file criminal charges in connection with the former governor’s handling of nursing home deaths during the pandemic.
Earlier this year, an independent investigation, commissioned by current New York Gov. Kathy Hochul, found that although Cuomo’s nursing home response policy was based on “the best available data at the time,” communication to the public was poor and caused anxiety for family members of nursing home residents.
“Even the most well-intentioned policy had unforeseen consequences in [New York state] nursing homes,” the report read.
(PORTLAND, Ore.) — A lawsuit is accusing an Oregon health care system of negligence after more than 2,000 patients were possibly exposed to HIV and hepatitis.
The plaintiffs — known as E.P, K.R., C.R. and D.C. — all of whom live in Clackamas County, Oregon, said they all received anesthesia for surgeries at various medical centers under Providence Health between March 2022 and February 2024, according to the complaint.
All the patients were later informed that the physician who administered anesthesia “failed to adhere to infection control procedures” and, as a result, all had potentially been exposed to hepatitis B, hepatitis C and HIV, the complaint says.
It is unclear which protocols were violated. Providence Health declined ABC News’ request for comment, citing “pending litigation.”
Hospital and health officials announced earlier this month that as many as 2,200 patients were possibly exposed to the infections. Providence said in a statement on July 11 that patients were at low risk of exposure and that those who were exposed would either receive a letter in the mail or a notification on the MyChart portal used by Providence.
“Out of an abundance of caution, we are encouraging these patients to get a blood test to screen for the aforementioned infections, at no cost,” Providence said in a statement. “If a patient tests positive, Providence will reach out to discuss their test results and next steps. ”
At the time, Oregon Health Authority said in a statement there were no investigations underway but “acknowledge[d] the worry, pain and loss suffered by anyone affected by a health care-associated infection (HAI).”
According to the complaint, the anesthesiologist was employed by Oregon Anesthesiology Group (OAG) but treated patients at various Providence medical centers between 2017 and 2023.
OAG stopped providing services to Providence in November 2023. In June 2024, OAG learned that one of its anesthesiologists had violated infection control practices. The physician was suspended and, following an investigation, terminated, the lawsuit states.
The group did not immediately respond to ABC News’ request for comment.
“The safety of our patients is our top priority. When we learned that the physician had violated infection control practices, we suspended him, informed our partners Legacy Health and Providence, and then began an investigation that resulted in the physician’s termination,” OAG said in a statement earlier this month, according to USA Today. “Even though the risk of infection was low, new protocols and procedures have been put in place to prevent similar incidents in the future.”
The lawsuit states that the patients now have to undergo medical treatment for exposure “which would not have been necessary in the absence of [the d]efendants’ violations alleged herein, and have to live with severe emotional and mental anguish due to [the defendants’] negligence.”
Additionally, the complaint states that hepatitis and HIV are often not detectable for months after initial infections, so the patient “will live with the anxiety, stress, and emotional distress that they may be infected with hepatitis B, hepatitis C and/or HIV.”
The Centers for Disease Control and Prevention states that HIV and Hepatitis C may be detected as early as weeks after exposure.
The plaintiffs are suing for negligence and/or gross negligence on the part of Providence and OAG and have asked for a jury trial. They are seeking class action certification and also asking for an unspecified amount in damages, injunctive relief, declaratory judgments, costs and attorneys’ fees, according to the complaint.
“Over 2,000 patients have now learned they were at risk of having contracted an infectious disease because of the defendants’ alleged failure to implement proper protocols to prevent this possible exposure,” Adam Polk of Girard Sharp, one of the attorneys representing the plaintiffs, said in a statement to ABC News.
“Since shortly after these notifications were sent out, we have been speaking with patients on a daily basis who were impacted by the potential exposure, they are obviously distressed and concerned about their health and the health of their loved ones,” attorney Joe Sauder of Sauder Schelkopf, who is also representing the plaintiffs, told ABC News in a statement.
(NEW YORK) — As the 2024 Summer Olympic Games in Paris came to an end this weekend, most of the conversation surrounded the number of medals won, and the number of records broken.
However, there was also another topic at hand: the presence of COVID-19 at the Olympics.
At least 40 athletes tested positive for COVID, according to the World Health Organization (WHO), including several Australian swimmers, a British swimmer and a German decathlon competitor.
Additionally, American track and field star Noah Lyles won bronze in the 200-meter race after testing positive for COVID-19 two days prior.
Despite the number of cases, public health experts told ABC News that the Paris Games were actually a success and a testament to how far the world has come since the early days of the COVID-19 pandemic in 2020.
“COVID-19 was so less disruptive in Paris than it was in Tokyo or Beijing because of what science and medicine have done over the past four years,” Dr. Amesh Adalja, an infectious disease physician and senior scholar at Johns Hopkins Center for Health Security, told ABC News.
“That should be the story, that we went from something that was disrupting the entire world to something that is now kind of a rank-and-file respiratory virus. I think that’s the real story. Here is the success of humanity with tackling this scientific problem, and the minds that went to work on this problem and made it something that is no longer a major concern for a lot of the population,” Adalja said.
How the Paris Olympics were different
The Paris Olympics were billed as the first games with some sense of normalcy after the strict restrictions seen during the 2021 Summer Games in Tokyo and the 2022 Winter Games in Beijing.
Athletes were under strict testing and quarantine protocols and had to follow stringent mitigation measures to participate in the 2021 or 2022 Games. No spectators were allowed at the Tokyo Games while a limited number were allowed at the Beijing Games.
Comparatively, there were no formal requirements for regular COVID-19 testing or reporting for the Paris Games, either in general or for specific events.
An athlete testing positive did not require them to sit out from an event either. Participating following a positive test was left up to the discretion of the athlete, team and medical staff. Additionally, there were no restrictions regarding spectators.
“The Paris Olympics were something that really resembled pre-COVID Olympics, nothing like what we saw in Beijing, nothing like what we saw in Tokyo,” Adalja said. “And I think that reflects the fact that the context regarding the virus that causes COVID-19 has changed a lot over the past four years.”
COVID at the Paris Games
Only about 40 COVID-19 cases were confirmed among athletes at the 2024 Summer Games. Experts say it’s not out of the ordinary that cases would occur and that, likely, the total is an undercount of cases.
“I am sure that that is a gross under-representation of the actual number of cases,” Dr. Pedro Piedra, a professor in the Department of Molecular Virology and Microbiology and Pediatrics at Baylor College of Medicine, Houston, told ABC News.
“[COVID] testing is not required, and testing for other respiratory viruses has really not been required either, and whenever you have such an event, it is an excellent ground for viruses to transmit. And that’s not just unique to the Olympics. That’s anytime you have a lot of individuals cluster over time together,” he continued.
The Australian Olympic Committee said last week that 16 athletes tested positive for COVID, at least seven of whom were swimmers.
The British Olympic Committee said swimmer Adam Peaty tested positive for COVID-19 less than 24 hours after winning silver in the men’s 100-meter breaststroke final.
Perhaps, most famous, Lyles — the American sprinter — revealed after winning bronze in the 200-meter men’s final that he had tested positive two days beforehand. Lyles drew a great deal of criticism for running the race unmasked and not publicly revealing his diagnosis before the competition.
However, experts said that COVID-19 is beginning to be considered an endemic virus, meaning it is typically present, and should be treated like other endemic viruses, like the flu.
“A lot has changed, and this virus is now what we would call an endemic virus; it’s basically part of the new respiratory viruses that circulate within our community,” Piedra said. “We don’t try to test every virus for every illness that we have. If we did, I think it would cost significantly, and on many occasions, we don’t have any form of treatment or prevention methods.”
Adalja said because COVID-19 is being considered an endemic respiratory virus, each individual case is less significantly important.
“We have so many tools that science and medicine have given us that make COVID-19 so much more manageable in 2024 than it was in 2020, 2021, 2022,” he said. “So, in that sense, the fact that you’re not hearing about every case as it occurs is just like you don’t hear about every case of influenza that occurs.”
He continued, “I think that the fact that people are back to their lives, that people are winning medals when they have COVID-19 really shows that despite all of the obstacles the governments put in place to deal with COVID appropriately, scientists, physicians delivered and developed so many tools that were able to now live our lives in the midst of COVID-19 and not have It be as disruptive as it once was.”