The U.S. Food and Drug Administration approved a study to see if the Galleri blood test can reduce late-stage cancer diagnoses for cancers that don’t have traditional screening approaches. Today, we explore this new cancer screening test.

In the ever-evolving healthcare landscape, groundbreaking innovations often emerge to challenge the status quo.

I am a cancer doctor and would love to see the disease caught earlier. Earlier detection typically translates into higher cure rates (with less intense treatment).

The recent approval by the U.S. Food and Drug Administration (FDA) for an investigational device study of the Galleri test marks a significant milestone in cancer screening.

The Galleri blood test can potentially revolutionize how we detect cancer. The approach offers a non-invasive and comprehensive approach that could change the narrative of early diagnosis.

Today, I will review this potentially groundbreaking test for early cancer detection.

Scope of the Problem

Did you know that only four cancer types have a screening test recommended by the United States Preventive Services Task Force (USPSTF)?

Here are the four cancers for which we have screening:

• Breast
• Cervix
• Colorectal
• Lung

These cancers comprise about three in 10 cancers in the United States. A fifth cancer — prostate — has a screening test that is not broadly recommended due to overdiagnosis.

The USPSTF explains that for men aged 55 to 69 years, the decision to undergo periodic prostate-specific antigen (PSA)-based screening for prostate cancer should be an individual one.

Cancer screening today: Too little, too late

Many cancer deaths are caused by cancers for which we do not have screening tests:

According to the University of Chicago (USA) estimates, 57 percent of all diagnosed cancers currently do not have a recommended screening test.

When I see such cancers in the clinic, they are usually in individuals who have symptoms. Often, the cancer presents in later stages that are more challenging to manage.

Moreover, these diagnoses account for 70 percent of cancer-related deaths. I am always disappointed to read that four out of 10 of us will get cancer (and one in five of us will die from the disease).

The Galleri Cancer Screening Blood Test

The Galleri test is not just a run-of-the-mill blood test; it’s a futuristic leap in cancer screening technology.

Unlike traditional methods that focus on specific types of cancer, the Galleri test takes a holistic approach by examining a broad range of cancer signals within the bloodstream.

Its brilliance lies in its ability to detect over 50 cancer types, potentially even before symptoms manifest.

How The Blood Test Works

Imagine a simple blood draw providing a window into your body’s health, offering insights into the presence of various cancers at an early, treatable stage.

This concept is not science fiction but a reality on the horizon. The Galleri test analyzes the unique patterns of DNA methylation, which are chemical modifications to DNA that can indicate the presence of cancer in the body.

Screening for a signal shared by 50+ cancers is now possible with the Galleri test — all with a single blood draw.

This innovative approach holds promise for early detection, a crucial factor in improving cancer outcomes.

Galleri Test Details

The Galleri test looks for signs of active cancer in your blood.

When you take the test, it examines more than 100,000 DNA regions and over a million specific DNA sites to check for a signal linked to over 50 types of cancers at the time of the test.

If it finds this signal, it can give an idea of the type of tissue or organ where the cancer might be.

Galleri is a screening test, not a diagnosis. If the test shows a potential cancer signal, you still need additional tests to confirm if you have cancer.

Also, Galleri doesn’t tell you about your future risk of getting cancer, and it’s not a genetic risk assessment.

The Food and Drug Administration Weighs In

On November 27, 2023, the United States Food and Drug Administration approved a Galleri multicancer early detection test study in Medicare patients.

The study is a research project to see how well the test works in an older population.

The approval is an important step in determining the safety and effectiveness of the test on a large scale. We are one step away from bringing this groundbreaking technology into routine medical practice.

Galleri Study Details

The study will follow the health results of about 50,000 older folks with Medicare.

Some will get the Galleri blood test every year and regular medical checkups.

Another group will only get their usual medical care.

Diversity

The people taking part in the Galleri study will come from different racial and ethnic backgrounds, and many of them are seniors from communities that haven’t had as much access to healthcare in the past.

The study’s main goal is to see if the Galleri blood test can find cancers earlier when they’re not as serious.

The hope is that catching cancers sooner will help reduce the need for expensive medical treatments.

My Take — A New Cancer Screening Test

The Galleri test’s ability to detect cancers in the early stages could significantly impact patient outcomes.

Early detection often translates to more treatment options, increased chances of successful intervention, and potentially lower treatment costs.

Moreover, it could alleviate the physical and emotional burden on individuals by sparing them from more invasive and aggressive treatments associated with advanced-stage cancers.

This remarkable test promises to transform cancer diagnosis from reactive to proactive.

Moreover, the Galleri test exemplifies the power of public-private partnerships.

The collaboration between research institutions, private companies, and regulatory bodies showcases the shared commitment to advancing healthcare.

We’re Not There Yet

While celebrating the potential of the Galleri test, it’s crucial to approach this breakthrough with cautious optimism.

The investigational device study is a crucial phase in the development process, designed to rigorously evaluate the test’s safety and efficacy.

This step ensures that the technology meets the highest standards before becoming routine in medical practice.

There are certainly questions: Will the test lead to many fruitless searches for cancer? What is the false-positive rate? False-negative? Costs?

In conclusion, the recent FDA approval for an investigational device study of the Galleri test potentially heralds a new era in cancer screening.

The potential of this blood test to detect multiple types of cancer at an early stage could reshape the landscape of cancer diagnosis and treatment.

As we eagerly await the study results, we find ourselves on the brink of a medical revolution that could redefine how we approach cancer care.

The current study will add to the existing data on Galleri from the NHS-Galleri trial and the PATHFINDER 2 Study.

Thank you for reading “A New Cancer Screening Test.”