September 13, 2025 • 26 mins
In this update to the August 2024 episode, Karen explains the surge of direct-to-consumer “whole-body” MRI/CT screenings and how to decide with your provider whether they’re a good fit. In the re-aired episode, Karen explores the Galleri test, a multi-cancer early detection (MCED) blood test that can identify over 50 types of cancer. She explains how the test works, its potential benefits, and the risks associated with its use. She also shares personal stories from individuals who benefited from the test, while discussing ongoing research to determine its effectiveness in improving cancer outcomes.
Visit our website itchyandbitchy.com to read blog posts on the many topics we have covered on the show.
Visit our website itchyandbitchy.com to read blog posts on the many topics we have covered on the show.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
The content of this podcast is provided for general informational
purposes only and is not intended as nor should it
be considered, a substitute for professional medical advice. Hello, this
(00:21):
is Karen Nickel, family nurse practitioner, and you are listening
to Itchy and Bitchy, a podcast that provides answers to
your many unanswered health questions. A year ago, I released
an episode called Blood Test for Multiple Cancers Yep, it exists,
and it was about a test called Gallery that looks
for over fifty different cancer biomarkers in your blood in
(00:44):
an effort to catch a problem early. Now I am
repeatedly seeing ads on social media for whole body scans
that are used as a screening tool, meaning the test
is done just to see what's going on in your book,
rather than doing a specific test to check for a
specific problem, like doing an abdominal ultrasounded check for gallstones
(01:08):
in someone with right upper quadrant pain. We are going
to rerun the August twenty twenty four episode about Gallery testing,
but first I'm going to tell you about these whole
body scans that are being advertised and review the pros
and cons of doing this type of testing. So First
of all, what does it mean to have a whole
(01:30):
body scan? Well, whole body scans use MRIs usually magnetic
resonance imaging to examine your entire body. These medical scans
can identify signs of injury or disease. The companies that
offer this product state that they can be valuable for
detecting health issues that aren't visible or show no signs yet.
(01:53):
Whole body scans provide detailed images of internal body structures,
and the most common type of full body testing that
is advertised on social media are MRII scans Magnetic resonance
imaging scans. They create detailed images of the body's soft tissues.
(02:14):
MRI scans do not involve the use of radiation, so
they are safer than imaging like a CT scan. CT
scans are also offered by these companies that you are
seeing popping up on your social media. CT scans are
commonly used to detect bone fractures, tumors, and internal injuries.
(02:35):
Before jumping into having this type of imaging service, I
recommend that you consider the advantages and disadvantages of whole
body scans. I'll start by listing the main benefits of
this type testing Having a full body scan can provide
early detection of health issues. They can identify cancer, heart disease,
(02:59):
and organ damage before they get worse. MRI CT and
other medical imaging procedures are non invasive. However, remember that
CT scans do involve the use of radiation and an
MRI test can take twenty to sixty minutes to complete.
Since full body scans can detect health issues without needing
(03:21):
invasive procedures, they can provide peace of mind for some individuals.
Problems found on imaging can give you and your provider
the opportunity to make decisions about lifestyle changes needed to
either prevent a worsening of a problem or actually have
a resolution of a problem. There are some negatives about
(03:45):
having this type of screening testing. It is possible to
have false positives and false negatives. Sometimes these tests can
be inaccurate, leading to these false positives and negatives. This happens,
you might end up having unnecessary tests or treatments you
don't need, or you might think you don't have a
(04:07):
problem when you actually do have a problem. As I
mentioned earlier, CT scans use radiation. Unnecessary exposure to this
radiation can increase your risk for conditions like cancer or
skin damage. Really really think twice before having a CT scan,
especially if it's just for screening or it's unnecessary based
(04:31):
on your health history. Full body scans can detect minor
abnormalities in the body that might not even cause any
health issues, but can cause undue stress and lead to
unnecessary invasive procedures. You might worry about something that doesn't
even need to be worried about. Opting to have this
(04:53):
type of testing could cause some financial strain and stress.
These services run from anywhere from five one hundred dollars
to four thousand dollars and insurance doesn't typically cover this
type of screening testing. However, both companies I will talk
about in a minute take FSA and HSA cards for payment.
(05:15):
A couple of companies that provide this type of testing
are Ezra and Prenouvo. The company called Ezra offers an
MRI of the head, neck, abdomen, and pelvis. That's their
main MRI scan. The arms and legs are not included
in this MRI. They charge four hundred and ninety nine
(05:36):
dollars for this imaging and it takes about twenty two
minutes to complete. They also offer an MRI with spine
that includes the parts of the body I just listed
plus the spine for a cost of one thousand, four
hundred and ninety nine dollars. You will be in an
MRI machine for forty seven minutes to have this testing completed.
(05:59):
At Ezra, you can also get an MRI scan with
skeletal and neurological assessment. It includes everything in the MRI
scan with spine and scans for signs of neurodegeneration, multiple sclerosis,
and dementia. It adds brain age analysis and measures fat
and muscle volume. It also includes MR imaging that evaluates
(06:24):
the health of knee and hip joints. This option involves
having two sixty minute MRIs done and costs three thousand,
nine hundred and ninety nine dollars. This company also has
a CT of the heart and lungs. This low dose
CT scan looks for lung cancer and other lung problems.
(06:46):
The CT images also provide a coronary calcium score to
determine if plaque is built up in your heart arteries.
This test does expose you to radiation and takes only
a few minutes to complete. Eat they charge three hundred
and forty nine dollars for this test. Another company that
provides testing is pre Nuvo. Their test, called Enhanced Screening
(07:10):
with Whole Body Scan, includes an MRI of the whole
body except the arms and feet, and includes blood work
that looks for cancer markers. The cost is three thousand,
nine hundred ninety nine dollars. The pre Nuvo whole body
scan includes head, neck, chest, abdomen, pelvis, and legs, and
(07:32):
it's checking for cancer, aneurysms, and disease for the price
of twenty four ninety nine two four hundred and ninety
nine dollars. For nine hundred and ninety nine dollars, you
can have their Torso scan, which is an MRI of
the chest, abdomen, and pelvis. Both companies use radiologists to
(07:53):
read their MRIs and cts. So who should consider this
testing well it It would be good to discuss it
with your provider to help make this decision. If, for example,
you have a family history of cancer, it might make
more sense for you to get genetic testing for specific
genetic mutations rather than having a whole body scan. Having
(08:17):
this information, the genetic information really can help determine the
best screening imaging for you based on your genetic patterns.
Someone who worries and stresses about their health should really
think twice before having testing like this done, because having
this information about even minor physical problems could cause more stress.
(08:43):
It is also important to note that to date, there
is no documented evidence that total body screening is cost
efficient or effective in prolonging life. Here's the Gallery episode.
Enjoy I was having with friends a few days ago
and they asked me what I knew about a blood
(09:04):
test that looks for lots of different types of cancers
and if they should do something like that. I figured,
if they were asking this question, all of you listeners
may have the same questions. So I'm going to talk
about one such test called the Gallery test, and that's
spelled GA L L EERI. The Gallery blood tests can
(09:28):
detect more than fifty types different types of cancer. It
looks for patterns in circulating DNA that can signal the
presence of cancer in your body, and its accuracy can
vary by cancer type. It also tells you the location
in the body of circulating DNA that's abnormal. The Gallery
(09:52):
test is a multi cancer early detection test. They label
that MCEED multi Cancer Early Detect Test MCED. It is
produced by a company called Grail as in the Holy
It can be used to identify cancer in asymptomatic adults
(10:12):
who are at higher risk of cancer, like those who
are over fifty fifty and over like me. It is
not indicative for people under the age of twenty one
or for those who are pregnant. There are some other
companies who have blood tests that look for a single
cancer like colon cancer, but I'm going to talk today
(10:32):
about the Gallery test that looks for over fifty types
of cancer. The Gallery test requires a blood sample that
is collected by a simple blood draw. Most, if not all,
of you have had this done, so you know that
involves collecting a small amount of blood from a vein
in your arm or sometimes your hand if you have
(10:54):
tricky veins. The blood sample is then sent to a
lab where the blood is analyzed for cell free DNA
using DNA sequency and machine learning. Okay, I don't know
about you, but I had no idea what machine learning
meant Forres is probably rolling his eyes as he hears
(11:16):
this while producing the episode. Anyway, I had to look
it up, and according to MIT, the Massachusetts Institute of Technology.
Machine learning is an artificial intelligence system, which is probably
why I didn't know anything about it, that is used
to perform complex tasks in a way that is similar
(11:37):
to how humans solve problems. There you go anyway. This
system is looking for cell free DNA, which is a
type of DNA that's been released from cells and is
present in the blood, so it's not contained within a cell.
It's been released from a cell and it's hanging around
in the blood. There are differences in this cell free
(12:00):
DNA of healthy cells and cancer cells. The Gallery test
looks for specific patterns of changes in the sel free
DNA that may signal that cancer is present. It can
also identify the area in the body where the cancer
may be. These tests do not diagnose cancer. These tests
(12:23):
do not diagnose cancer. A positive result will probably lead
to additional imaging tests or biopsy to confirm a diagnosis
of cancer. At this point, medical experts say the tests
aren't replacing the screening tests that are currently standard of care,
such as colonoscopy, mammography, or pap smear, because mceed can
(12:48):
help find cancers in their early stages when they're easier
to treat. This type of test can be used to
supplement our current screening test, so they supplement, but do
not replace, our current screening tests. The gallery tests can identify,
as I said, more than fifty types of cancer, so
(13:09):
clearly I am not going to list them all here
you can say thank you now, thank you, Karen. But
it does include some of the most common cancer types,
such as cancer of the breast, lung, prostate, colon, and rectum.
The tests can also identify cancers that are much less
common and that are not typically screened. A couple of
(13:32):
examples include ampullary cancer, which is a rare form of
gastrointestinal cancer, and also it can detect certain types of
soft tissue sarcoma that are commonly hidden deep in the body.
So sarcoma is often diagnosed when it has already become
too large to expect any hope of being cured. Although
(13:56):
a lot of lumps and bumps we get are not
cancerous for sure, you should have lumps looked at by
your provider when you first notice them in case it's
a sarcoma, we want to make sure it's not a sarcoma.
The test may be especially useful in finding what we
call silent cancers like pancreatic or ovarian cancer, both of
(14:20):
which often don't cause symptoms until the disease is advanced
and more difficult to treat. There are some things that
we do not know about the Gallery test. One unknown
is whether or not using it as a part of
cancer screening will help to improve people's outcomes and save lives.
(14:43):
There are clinical trials currently in progress to help determine this.
The largest trial is the NHS Gallery Trial, which is
currently underway in the United Kingdom. The goal of the
trial is to see if using the Gallery test, along
with established cancer screening methods can help to find and
(15:05):
treat cancers earlier. About one hundred and forty thousand people
with no history of cancer in the past three years
volunteered to take part in this trial. Everyone in the
trial will have three blood tests over two years. Half
of the participants will have their samples analyzed using GALLERY,
(15:26):
the other half will not. The National Cancer Institute the NCI,
is also studying the benefits of MCD tests such as
Gallery in preventing cancer deaths. This year twenty twenty four,
the preliminary study will enroll twenty four thousand healthy people.
If MCED tests in this study are found to be useful,
(15:50):
a larger study of up to two hundred and twenty
five thousand people will be initiated. In the meantime, there
are anecdotal reports of the benefits of the test. A
Washington Post article dated April sixteen, twenty twenty four, had
four of these personal experiences featured. When her husband was
(16:13):
undergoing cancer treatment, a woman who lives in Florida found
out about the Gallery test, and her husband encouraged her
to take the test in spite of the fact that
she was a healthy, fifty year old woman without any symptoms.
She was quite surprised when the result came back positive.
(16:33):
She had follow up scans that revealed a small tumor
in her groin, which was diagnosed as a rare but
aggressive form of cancer called mantle cell lymphoma. She underwent
treatment and now two years later she's in remission. The
Florida woman states that, quote for me, the test was
a miracle, a real big miracle, end quote. A fifty
(16:57):
six year old woman from Arizona had a positive of
Gallery tests, so a follow up MRI found that she had,
in her words, an angry gallbladder that needed to come out,
so she had no symptoms, but the pathology on the
removed gallbladder showed a small malignant tumor among the gallstones.
(17:19):
After treatment, the woman reports that she is now cancer free.
Up ahead more stories of how the Gallery test benefited people.
So stay with me, welcome back. I want to share
(17:49):
with you a couple more stories of people who had
personal experiences with MCED testing. A seventy five year old
woman from Pennsylvania had a test done when she was
enrolled in a twenty eighteen study called Cancer Seek. She
had a positive test, and follow up scans revealed LYO
(18:10):
myos sarcoma in her uterus. She had a hysterectomy, and
the woman reports that the surgeon was able to remove
the entire tumor. The Washington Post article quotes her as saying, quote,
I don't know how aggressive it would have been, but
I have one grandchild and I was able to see
him graduate from high school. I'm looking forward to his
(18:32):
college graduation and later to my great grandkids. End quote.
A final story is that of a sixty nine year
old man from California who agreed to do the Gallery
test when his physician suggested it. Everything about that annual exam,
including his blood work, was normal, so he was surprised
to be told that the Gallery test came back positive.
(18:56):
Follow Up testing found cancer in a lymph node on
aunder his right armpit, which turned out to be a
form of Hodgkin's lymphoma. After radiation and chemotherapy, he reports
that he's currently cancer free. He states that if he
hadn't had the test done, quote, where would I be? Now?
Who knows? But it wouldn't have gone away? End quote?
(19:19):
So how accurate is this testing? A twenty twenty one
validation study looked into the accuracy of the Gallery test.
It included two thy eight hundred and twenty three people
with a known diagnosis of cancer and one two hundred
and fifty four healthy people no cancer. The study found
(19:40):
that the Gallery test had ninety nine point five percent specificity,
meaning it was very accurate for determining when a person
didn't have cancer related signals in their sample, making false
positive results very unlikely. The overall sensitivity d was fifty
(20:01):
one point five percent, meaning that it correctly identified fifty
one percent of the people with cancer related signals in
their sample. The test missed cancer related signals in the
remaining percentage of people, which means forty eight point five
percent of the people. This means that these people received
(20:22):
a false negative result. The sensitivity of the Gallery test
improved with higher stages of cancer, meaning it was more
likely to identify cancer related signals in people with more
advanced cancers. The study also found that in those who
received a positive result and had cancer, the Gallery test
(20:45):
correctly identified the site of origin of the cancer in
eighty eight point seven percent of people. Pretty impressive. There
are some downsides or risks to the Gallery test. First,
although it can look at for over fifty types of cancer,
it doesn't detect all types of cancer, so you can
(21:07):
still have a type of cancer that the test cannot
find even if you have a negative test. Secondly, there
is a chance that you could have a false negative test,
meaning that the test is negative when you actually do
have cancer. In this case, a negative test can give
(21:28):
you a false sense of security and delay necessary testing
to discover the cancer. Thirdly, although studies show the rates
of false positive and negatives are low among the new
cancer blood tests, a false positive could cause a lot
of anxiety and lead to invasive and costly tests. If
(21:52):
you're interested in having the Gallery test, talk with your
provider about it. If they are knowledgeable about they can
help you determine whether or not you're a good candidate
for the test, and also provide you with the information
about different benefits and risks associated with the test. The
(22:13):
Gallery Test has a list cost of nine hundred and
forty nine dollars according to Grail, the company that makes
a test. Some individual employers may cover some or all
of the cost of testing. Both the American Cancer Society
and the National Cancer Institute report that most types of
(22:35):
insurance don't typically cover the Gallery Test. This means that
you'll likely have to pay some or all of the
cost of the test out of pocket. Medicare currently does
not cover the cost of the Gallery test either, but
a bill on this topic was introduced into Congress in
twenty twenty one. I checked the status of the bill
(22:58):
today on congress dot Com UK gov the website Congress
dot Gov, which states that it has been quote read
twice and referred to the Committee on Finance end quote.
The last update on the progress of the bill was
in June of twenty twenty three. If an acted into law,
which at this point seems unlikely as it sits with
(23:21):
the Committee of Finance. It would provide Medicare coverage for
MCEED such as the Gallery Test. At this time, no
MCEED tests have been approved by the Food and Drug
Administration the FDA, and this includes the Gallery Test instead.
The Gallery Test is available under a Clinical Laboratory Improvement
(23:44):
Amendments CLIA, which we call CLIA waiver since the actual
testing of the sample is done in a central laboratory
regulated by CLEIA. CLIA is a federal program that sets
and insures quality standards for clinical laboratory toy testing. The
Gallery Test was also given a Breakthrough Device designation by
(24:06):
the FDA in twenty nineteen. The FDA's Breakthrough Devices Program
designates medical devices that may increase the effectiveness of the
diagnosis or treatment of life threatening diseases. The goal of
providing this designation is to provide timely access to these
devices while they are being further developed and study. So
(24:31):
if you're at an increased risk of cancer, a medical
provider can order the Gallery Test on the Gallery website. Today,
I've outlined the risks and benefits of this testing for you,
but you should review them with your healthcare provider to
help determine if the Gallery Test is a good fit
for you, and if it is, hopefully your provider will
(24:53):
be willing to order the Gallery Test or other MCED
tests for you. Thank you for listening. Wherever you listen
to this podcast, please leave a review and rate the podcast.
Your reviews and ratings really do matter. Also make sure
you follow the show so that it will be automatically downloaded.
That matters a lot. I encourage you to visit our
(25:16):
Facebook page imb Podcast, where you can give us a
like and leave comments or questions for me. Our website
is Itchy Andbitchy dot com with our blogs with some
of our subjects available for you to read. As always,
thanks to Forest Winsl my son, our producer and composer
of our theme music and the person who does all
(25:38):
the behind the scenes work to make this podcast possible.
Thank you so much Forrest. Forest has begun his second
year of his master's degree in music composition at Peabody
Music Conservatory and is already loving it. I am so
very proud of him, and please remember thank you for
passing s
The content of this podcast is provided for general informational
purposes only and is not intended as nor should it
be considered, a substitute for professional medical advice. Hello, this
(00:21):
is Karen Nickel, family nurse practitioner, and you are listening
to Itchy and Bitchy, a podcast that provides answers to
your many unanswered health questions. A year ago, I released
an episode called Blood Test for Multiple Cancers Yep, it exists,
and it was about a test called Gallery that looks
for over fifty different cancer biomarkers in your blood in
(00:44):
an effort to catch a problem early. Now I am
repeatedly seeing ads on social media for whole body scans
that are used as a screening tool, meaning the test
is done just to see what's going on in your book,
rather than doing a specific test to check for a
specific problem, like doing an abdominal ultrasounded check for gallstones
(01:08):
in someone with right upper quadrant pain. We are going
to rerun the August twenty twenty four episode about Gallery testing,
but first I'm going to tell you about these whole
body scans that are being advertised and review the pros
and cons of doing this type of testing. So First
of all, what does it mean to have a whole
(01:30):
body scan? Well, whole body scans use MRIs usually magnetic
resonance imaging to examine your entire body. These medical scans
can identify signs of injury or disease. The companies that
offer this product state that they can be valuable for
detecting health issues that aren't visible or show no signs yet.
(01:53):
Whole body scans provide detailed images of internal body structures,
and the most common type of full body testing that
is advertised on social media are MRII scans Magnetic resonance
imaging scans. They create detailed images of the body's soft tissues.
(02:14):
MRI scans do not involve the use of radiation, so
they are safer than imaging like a CT scan. CT
scans are also offered by these companies that you are
seeing popping up on your social media. CT scans are
commonly used to detect bone fractures, tumors, and internal injuries.
(02:35):
Before jumping into having this type of imaging service, I
recommend that you consider the advantages and disadvantages of whole
body scans. I'll start by listing the main benefits of
this type testing Having a full body scan can provide
early detection of health issues. They can identify cancer, heart disease,
(02:59):
and organ damage before they get worse. MRI CT and
other medical imaging procedures are non invasive. However, remember that
CT scans do involve the use of radiation and an
MRI test can take twenty to sixty minutes to complete.
Since full body scans can detect health issues without needing
(03:21):
invasive procedures, they can provide peace of mind for some individuals.
Problems found on imaging can give you and your provider
the opportunity to make decisions about lifestyle changes needed to
either prevent a worsening of a problem or actually have
a resolution of a problem. There are some negatives about
(03:45):
having this type of screening testing. It is possible to
have false positives and false negatives. Sometimes these tests can
be inaccurate, leading to these false positives and negatives. This happens,
you might end up having unnecessary tests or treatments you
don't need, or you might think you don't have a
(04:07):
problem when you actually do have a problem. As I
mentioned earlier, CT scans use radiation. Unnecessary exposure to this
radiation can increase your risk for conditions like cancer or
skin damage. Really really think twice before having a CT scan,
especially if it's just for screening or it's unnecessary based
(04:31):
on your health history. Full body scans can detect minor
abnormalities in the body that might not even cause any
health issues, but can cause undue stress and lead to
unnecessary invasive procedures. You might worry about something that doesn't
even need to be worried about. Opting to have this
(04:53):
type of testing could cause some financial strain and stress.
These services run from anywhere from five one hundred dollars
to four thousand dollars and insurance doesn't typically cover this
type of screening testing. However, both companies I will talk
about in a minute take FSA and HSA cards for payment.
(05:15):
A couple of companies that provide this type of testing
are Ezra and Prenouvo. The company called Ezra offers an
MRI of the head, neck, abdomen, and pelvis. That's their
main MRI scan. The arms and legs are not included
in this MRI. They charge four hundred and ninety nine
(05:36):
dollars for this imaging and it takes about twenty two
minutes to complete. They also offer an MRI with spine
that includes the parts of the body I just listed
plus the spine for a cost of one thousand, four
hundred and ninety nine dollars. You will be in an
MRI machine for forty seven minutes to have this testing completed.
(05:59):
At Ezra, you can also get an MRI scan with
skeletal and neurological assessment. It includes everything in the MRI
scan with spine and scans for signs of neurodegeneration, multiple sclerosis,
and dementia. It adds brain age analysis and measures fat
and muscle volume. It also includes MR imaging that evaluates
(06:24):
the health of knee and hip joints. This option involves
having two sixty minute MRIs done and costs three thousand,
nine hundred and ninety nine dollars. This company also has
a CT of the heart and lungs. This low dose
CT scan looks for lung cancer and other lung problems.
(06:46):
The CT images also provide a coronary calcium score to
determine if plaque is built up in your heart arteries.
This test does expose you to radiation and takes only
a few minutes to complete. Eat they charge three hundred
and forty nine dollars for this test. Another company that
provides testing is pre Nuvo. Their test, called Enhanced Screening
(07:10):
with Whole Body Scan, includes an MRI of the whole
body except the arms and feet, and includes blood work
that looks for cancer markers. The cost is three thousand,
nine hundred ninety nine dollars. The pre Nuvo whole body
scan includes head, neck, chest, abdomen, pelvis, and legs, and
(07:32):
it's checking for cancer, aneurysms, and disease for the price
of twenty four ninety nine two four hundred and ninety
nine dollars. For nine hundred and ninety nine dollars, you
can have their Torso scan, which is an MRI of
the chest, abdomen, and pelvis. Both companies use radiologists to
(07:53):
read their MRIs and cts. So who should consider this
testing well it It would be good to discuss it
with your provider to help make this decision. If, for example,
you have a family history of cancer, it might make
more sense for you to get genetic testing for specific
genetic mutations rather than having a whole body scan. Having
(08:17):
this information, the genetic information really can help determine the
best screening imaging for you based on your genetic patterns.
Someone who worries and stresses about their health should really
think twice before having testing like this done, because having
this information about even minor physical problems could cause more stress.
(08:43):
It is also important to note that to date, there
is no documented evidence that total body screening is cost
efficient or effective in prolonging life. Here's the Gallery episode.
Enjoy I was having with friends a few days ago
and they asked me what I knew about a blood
(09:04):
test that looks for lots of different types of cancers
and if they should do something like that. I figured,
if they were asking this question, all of you listeners
may have the same questions. So I'm going to talk
about one such test called the Gallery test, and that's
spelled GA L L EERI. The Gallery blood tests can
(09:28):
detect more than fifty types different types of cancer. It
looks for patterns in circulating DNA that can signal the
presence of cancer in your body, and its accuracy can
vary by cancer type. It also tells you the location
in the body of circulating DNA that's abnormal. The Gallery
(09:52):
test is a multi cancer early detection test. They label
that MCEED multi Cancer Early Detect Test MCED. It is
produced by a company called Grail as in the Holy
It can be used to identify cancer in asymptomatic adults
(10:12):
who are at higher risk of cancer, like those who
are over fifty fifty and over like me. It is
not indicative for people under the age of twenty one
or for those who are pregnant. There are some other
companies who have blood tests that look for a single
cancer like colon cancer, but I'm going to talk today
(10:32):
about the Gallery test that looks for over fifty types
of cancer. The Gallery test requires a blood sample that
is collected by a simple blood draw. Most, if not all,
of you have had this done, so you know that
involves collecting a small amount of blood from a vein
in your arm or sometimes your hand if you have
(10:54):
tricky veins. The blood sample is then sent to a
lab where the blood is analyzed for cell free DNA
using DNA sequency and machine learning. Okay, I don't know
about you, but I had no idea what machine learning
meant Forres is probably rolling his eyes as he hears
(11:16):
this while producing the episode. Anyway, I had to look
it up, and according to MIT, the Massachusetts Institute of Technology.
Machine learning is an artificial intelligence system, which is probably
why I didn't know anything about it, that is used
to perform complex tasks in a way that is similar
(11:37):
to how humans solve problems. There you go anyway. This
system is looking for cell free DNA, which is a
type of DNA that's been released from cells and is
present in the blood, so it's not contained within a cell.
It's been released from a cell and it's hanging around
in the blood. There are differences in this cell free
(12:00):
DNA of healthy cells and cancer cells. The Gallery test
looks for specific patterns of changes in the sel free
DNA that may signal that cancer is present. It can
also identify the area in the body where the cancer
may be. These tests do not diagnose cancer. These tests
(12:23):
do not diagnose cancer. A positive result will probably lead
to additional imaging tests or biopsy to confirm a diagnosis
of cancer. At this point, medical experts say the tests
aren't replacing the screening tests that are currently standard of care,
such as colonoscopy, mammography, or pap smear, because mceed can
(12:48):
help find cancers in their early stages when they're easier
to treat. This type of test can be used to
supplement our current screening test, so they supplement, but do
not replace, our current screening tests. The gallery tests can identify,
as I said, more than fifty types of cancer, so
(13:09):
clearly I am not going to list them all here
you can say thank you now, thank you, Karen. But
it does include some of the most common cancer types,
such as cancer of the breast, lung, prostate, colon, and rectum.
The tests can also identify cancers that are much less
common and that are not typically screened. A couple of
(13:32):
examples include ampullary cancer, which is a rare form of
gastrointestinal cancer, and also it can detect certain types of
soft tissue sarcoma that are commonly hidden deep in the body.
So sarcoma is often diagnosed when it has already become
too large to expect any hope of being cured. Although
(13:56):
a lot of lumps and bumps we get are not
cancerous for sure, you should have lumps looked at by
your provider when you first notice them in case it's
a sarcoma, we want to make sure it's not a sarcoma.
The test may be especially useful in finding what we
call silent cancers like pancreatic or ovarian cancer, both of
(14:20):
which often don't cause symptoms until the disease is advanced
and more difficult to treat. There are some things that
we do not know about the Gallery test. One unknown
is whether or not using it as a part of
cancer screening will help to improve people's outcomes and save lives.
(14:43):
There are clinical trials currently in progress to help determine this.
The largest trial is the NHS Gallery Trial, which is
currently underway in the United Kingdom. The goal of the
trial is to see if using the Gallery test, along
with established cancer screening methods can help to find and
(15:05):
treat cancers earlier. About one hundred and forty thousand people
with no history of cancer in the past three years
volunteered to take part in this trial. Everyone in the
trial will have three blood tests over two years. Half
of the participants will have their samples analyzed using GALLERY,
(15:26):
the other half will not. The National Cancer Institute the NCI,
is also studying the benefits of MCD tests such as
Gallery in preventing cancer deaths. This year twenty twenty four,
the preliminary study will enroll twenty four thousand healthy people.
If MCED tests in this study are found to be useful,
(15:50):
a larger study of up to two hundred and twenty
five thousand people will be initiated. In the meantime, there
are anecdotal reports of the benefits of the test. A
Washington Post article dated April sixteen, twenty twenty four, had
four of these personal experiences featured. When her husband was
(16:13):
undergoing cancer treatment, a woman who lives in Florida found
out about the Gallery test, and her husband encouraged her
to take the test in spite of the fact that
she was a healthy, fifty year old woman without any symptoms.
She was quite surprised when the result came back positive.
(16:33):
She had follow up scans that revealed a small tumor
in her groin, which was diagnosed as a rare but
aggressive form of cancer called mantle cell lymphoma. She underwent
treatment and now two years later she's in remission. The
Florida woman states that, quote for me, the test was
a miracle, a real big miracle, end quote. A fifty
(16:57):
six year old woman from Arizona had a positive of
Gallery tests, so a follow up MRI found that she had,
in her words, an angry gallbladder that needed to come out,
so she had no symptoms, but the pathology on the
removed gallbladder showed a small malignant tumor among the gallstones.
(17:19):
After treatment, the woman reports that she is now cancer free.
Up ahead more stories of how the Gallery test benefited people.
So stay with me, welcome back. I want to share
(17:49):
with you a couple more stories of people who had
personal experiences with MCED testing. A seventy five year old
woman from Pennsylvania had a test done when she was
enrolled in a twenty eighteen study called Cancer Seek. She
had a positive test, and follow up scans revealed LYO
(18:10):
myos sarcoma in her uterus. She had a hysterectomy, and
the woman reports that the surgeon was able to remove
the entire tumor. The Washington Post article quotes her as saying, quote,
I don't know how aggressive it would have been, but
I have one grandchild and I was able to see
him graduate from high school. I'm looking forward to his
(18:32):
college graduation and later to my great grandkids. End quote.
A final story is that of a sixty nine year
old man from California who agreed to do the Gallery
test when his physician suggested it. Everything about that annual exam,
including his blood work, was normal, so he was surprised
to be told that the Gallery test came back positive.
(18:56):
Follow Up testing found cancer in a lymph node on
aunder his right armpit, which turned out to be a
form of Hodgkin's lymphoma. After radiation and chemotherapy, he reports
that he's currently cancer free. He states that if he
hadn't had the test done, quote, where would I be? Now?
Who knows? But it wouldn't have gone away? End quote?
(19:19):
So how accurate is this testing? A twenty twenty one
validation study looked into the accuracy of the Gallery test.
It included two thy eight hundred and twenty three people
with a known diagnosis of cancer and one two hundred
and fifty four healthy people no cancer. The study found
(19:40):
that the Gallery test had ninety nine point five percent specificity,
meaning it was very accurate for determining when a person
didn't have cancer related signals in their sample, making false
positive results very unlikely. The overall sensitivity d was fifty
(20:01):
one point five percent, meaning that it correctly identified fifty
one percent of the people with cancer related signals in
their sample. The test missed cancer related signals in the
remaining percentage of people, which means forty eight point five
percent of the people. This means that these people received
(20:22):
a false negative result. The sensitivity of the Gallery test
improved with higher stages of cancer, meaning it was more
likely to identify cancer related signals in people with more
advanced cancers. The study also found that in those who
received a positive result and had cancer, the Gallery test
(20:45):
correctly identified the site of origin of the cancer in
eighty eight point seven percent of people. Pretty impressive. There
are some downsides or risks to the Gallery test. First,
although it can look at for over fifty types of cancer,
it doesn't detect all types of cancer, so you can
(21:07):
still have a type of cancer that the test cannot
find even if you have a negative test. Secondly, there
is a chance that you could have a false negative test,
meaning that the test is negative when you actually do
have cancer. In this case, a negative test can give
(21:28):
you a false sense of security and delay necessary testing
to discover the cancer. Thirdly, although studies show the rates
of false positive and negatives are low among the new
cancer blood tests, a false positive could cause a lot
of anxiety and lead to invasive and costly tests. If
(21:52):
you're interested in having the Gallery test, talk with your
provider about it. If they are knowledgeable about they can
help you determine whether or not you're a good candidate
for the test, and also provide you with the information
about different benefits and risks associated with the test. The
(22:13):
Gallery Test has a list cost of nine hundred and
forty nine dollars according to Grail, the company that makes
a test. Some individual employers may cover some or all
of the cost of testing. Both the American Cancer Society
and the National Cancer Institute report that most types of
(22:35):
insurance don't typically cover the Gallery Test. This means that
you'll likely have to pay some or all of the
cost of the test out of pocket. Medicare currently does
not cover the cost of the Gallery test either, but
a bill on this topic was introduced into Congress in
twenty twenty one. I checked the status of the bill
(22:58):
today on congress dot Com UK gov the website Congress
dot Gov, which states that it has been quote read
twice and referred to the Committee on Finance end quote.
The last update on the progress of the bill was
in June of twenty twenty three. If an acted into law,
which at this point seems unlikely as it sits with
(23:21):
the Committee of Finance. It would provide Medicare coverage for
MCEED such as the Gallery Test. At this time, no
MCEED tests have been approved by the Food and Drug
Administration the FDA, and this includes the Gallery Test instead.
The Gallery Test is available under a Clinical Laboratory Improvement
(23:44):
Amendments CLIA, which we call CLIA waiver since the actual
testing of the sample is done in a central laboratory
regulated by CLEIA. CLIA is a federal program that sets
and insures quality standards for clinical laboratory toy testing. The
Gallery Test was also given a Breakthrough Device designation by
(24:06):
the FDA in twenty nineteen. The FDA's Breakthrough Devices Program
designates medical devices that may increase the effectiveness of the
diagnosis or treatment of life threatening diseases. The goal of
providing this designation is to provide timely access to these
devices while they are being further developed and study. So
(24:31):
if you're at an increased risk of cancer, a medical
provider can order the Gallery Test on the Gallery website. Today,
I've outlined the risks and benefits of this testing for you,
but you should review them with your healthcare provider to
help determine if the Gallery Test is a good fit
for you, and if it is, hopefully your provider will
(24:53):
be willing to order the Gallery Test or other MCED
tests for you. Thank you for listening. Wherever you listen
to this podcast, please leave a review and rate the podcast.
Your reviews and ratings really do matter. Also make sure
you follow the show so that it will be automatically downloaded.
That matters a lot. I encourage you to visit our
(25:16):
Facebook page imb Podcast, where you can give us a
like and leave comments or questions for me. Our website
is Itchy Andbitchy dot com with our blogs with some
of our subjects available for you to read. As always,
thanks to Forest Winsl my son, our producer and composer
of our theme music and the person who does all
(25:38):
the behind the scenes work to make this podcast possible.
Thank you so much Forrest. Forest has begun his second
year of his master's degree in music composition at Peabody
Music Conservatory and is already loving it. I am so
very proud of him, and please remember thank you for
passing s
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