When and how will we know if MCEDs are worth it?
Volume 11, Issue 15 | April 10, 2025
ALSO IN THIS ISSUE
FDA decreases animal testing requirements for monoclonal antibodies
Bird Flu Update: 1,000 herds and counting
Measles Outbreaks: Another child has died
PCR detects seafood fraud
Blood test predicts improvement after spinal-cord injury
Telehealth provides second-opinion options
FDA decreases animal testing requirements for monoclonal antibodies
The FDA announced today that drug companies developing monoclonal antibody therapies can begin to replace animal testing in their clinical trials with “more human-relevant methods.” Such methods include AI-simulated data and data obtained from organs on a chip as well as real-world human data from other countries. The move is expected to both decrease the cost and speed the process of drug research.
HHS layoffs: Details continue to emerge
All 28 employees of the CDC’s laboratory that deals with sexually transmitted diseases (STDs) were fired last week. This comes “At a time when the world is down to a single drug that can reliably cure gonorrhea,” as STAT News noted.
Since last week, HHS has made several additional announcements, some of which are seemingly at odds with each other. Several articles (here, here, here) suggested that 20% of last week’s firings were mistakes, and that the affected staff would be rehired (no details were provided on who, why, or where). At least one report has now cast doubt on whether those rehirings would happen - as of press time, they had not, but time will tell.
Bird Flu Update: Count is now 1K dairy herds, 23M poultry
Most of FDA’s bird flu staff fired
Immigration raids make dairy, poultry workers even more likely to avoid public-health staff
No human-to-human spread in CA child case
One thousand US dairy herds have now been infected with H5N1 since March 2024. Poultry flocks continue to be affected, as well, with over 23 million birds infected since the beginning of this year.
The senior veterinarians, administrative staff, and chief medical officer of the FDA were all fired this past week. The move eliminates most of the people in the agency who were working to curb bird flu. One immediate result: FDA “is suspending efforts to improve its bird flu testing of milk, cheese, and pet food,” Reuters reports.
Most of the human cases of bird flu in this country have happened in dairy and poultry workers, a community that’s always been hard for public-health workers to reach. It’s become even harder, KFF Health News reports, as Border Patrol and Immigration Control Enforcement raids have targeted immigrant communities. With workers unwilling to speak to government officials, let alone get tested for flu, public health has lost both its window into what human cases are happening and its ability to prevent infections in the community most likely to be affected.
At least 130 domestic cats across the nation have been infected with bird flu. Some had contact with infected birds, while others got the virus from contaminated raw pet food. The virus is extremely dangerous in cats, with a reported mortality rate of 50 - 70%.
Testing has confirmed that the California child whose H5N1 infection was announced in February did not spread the virus to any other people.
Measles Outbreaks: Vax clinics canceled, another child has died
Vaccination clinics in Dallas County, Texas, have been canceled due to federal cuts to public-health funding.
A second unvaccinated, otherwise healthy child in Texas has died from measles. That brings the possible death count to three (the third case, a person in New Mexico, has not been confirmed). Since measles usually kills about 1 to 3 per 1,000 unvaccinated people, this number suggests that many measles cases are not being reported.
The current larger outbreaks are shown below. The cases in Texas, New Mexico, Kansas, and Oklahoma all came from the same source; the outbreaks in Indiana, Ohio and Tennessee are unrelated.
PCR can tell when your catch is fishy
Rapid PCR testing will soon be used at ports around the nation to ensure that endangered species are not being sold as legal catch. Until now, detecting seafood fraud (yes, that’s a thing) has relied on visual identification - or, when that’s not possible, on lab-based testing, which can take weeks. According to NOAA Fisheries, the PCR tests can identify “more than 100 species, including tuna, shark, and eel, with additional genetic markers planned for future development.” The tests have already been used to identify more than 27 tons of illegally harvested fish.
Blood test predicts improvement after spinal-cord injury
We’ve talked a lot about cell-free DNA (cfDNA) and its use in cancer detection (see article about multi-cancer early detection tests below). Research published this week shows that it can also be used to tell how severe a spinal-cord injury is.
The study looked at 50 people with acute spinal-cord injury. The worse a person’s injury was, the higher the level of cfDNA found in their blood. When combined with a group of four proteins, the level of cfDNA in an injured person’s blood also predicted with about 77% accuracy whether their neurologic condition would improve over the next six months.
When and how will we ever know whether multi-cancer early detection tests are worthwhile?
Assuming that earlier diagnosis does reduce mortality (whether that’s true is not as simple as you might think) the key questions for multi-cancer early detection tests (MCEDs) are twofold.
How broadly multi-cancer can any single test be?
How well will MCEDs detect progression-prone early-stage cancers?
A recent CAP Today article suggests that the answer to #1 may be “not very.” MCEDs look for tumor DNA in the bloodstream, which is shed when tumor cells die. However, some tumor types have a closer connection to the blood supply than others. In addition, lung, colorectal, breast, and esophageal cancers shed a lot of tumor DNA, while prostate, brain, sarcoma, and thyroid cancers shed little. Together, these results imply that multi-cancer tests are never going to be equally effective across all cancer types.
The same article also implies that the answer to #2 may be “not terribly well.” Larger tumors that are more biologically active and/or have metastasized likely shed more than those that are more isolated. That’s why none of the MCEDs currently available are very good at early-stage detection.
So when will we get definitive answers? Hanging over a recent Tri-Con Conference panel on MCEDs was the specter of cuts in federal funding for health research. If those cuts end up delaying and/or derailing the large NIH/NCI Vanguard study designed to help shed light on these questions, then what?
Then we look to the large national trial underway at the UK’s NHS. Its goal is to figure out how much regular MCED testing reduces cancer mortality, especially for the 70% of cases for which there is no current screening methodology.
Regardless of the study, we’re going to have to wait a while before we get answers. It takes a good 10 - 15 years to detect a link between any test and mortality reduction. And the question of how good the evidence needs to be to go ahead and recommend MCEDs for all remains open.
Telehealth provides second-opinion options
Getting a second opinion is a non-trivial time investment - and for people who live in areas where oncologists are few, it can be impossible. New evidence suggests that that investment may be a worthwhile one, however, especially when it comes to cancer treatment. And it can be successfully delivered via telehealth, decreasing the burden on patients.
In a recent study, 657 cancer patients got a telehealth-based second opinion about their treatment from clinicians at a major cancer center. Of those, 54% received recommendations to change that treatment (minor changes in 34% of cases and major changes in 20%). Further work will determine whether patients tend to take these recommendations, and if so, whether they lead to better outcomes. (We know that this story is not testing-based, but we thought it was interesting enough to share.)
Clarification
Just to be clear - while the development of the non-invasive test in our article, Moving beyond the smiley-face pain scale, did require giving trial subjects a painful injection, the test itself does not. It uses a simple external EEG-like device to predict likely perceptions of pain. The trial subjects endured a painful stimulus so the rest of us would not have to!
It's great to make the connection between factory farming and the spread of disease, but it is surprising how little policy for preventative measures is discussed when it comes to factory farming conditions.