Nagalase is an enzyme that can be easily measured in the blood that seems to rise during the very early stages of cancer cell development. Cancer cells produce nagalase in order to suppress the immune system and augment cancer cell growth.
Does this test show as much promise as advertised as an accurate early cancer detection method? Read on to learn more about the controversial research surrounding it and decide for yourself.
What is Nagalase?
Nagalase (α-N-acetylgalactosaminidase) is an enzyme that breaks down certain glycoproteins (sugars attached to protein) and glycolipids (sugars attached to lipids/fats). It has a very important role and is essential for the body to function normally .
We know this because people who lack this enzyme develop a disease called Schindler or Kanzaki disease , where cellular malfunction leads to moderate to severe neurological problems.
How Nagalase Became (In)Famous
Nagalase can suppress the immune system by suppressing the activity of some very important immune cells called macrophages. Macrophages are white blood cells also called the “Pac-Men” because they devour invading microbes and altered cancer cells.
Specifically, nagalase breaks down the Gc protein (known as vitamin D3 binding protein or VDBP), which inhibits the production of Gc Macrophage Activating Factor (GcMAF), .
The logic is as follows: cancer cells and viruses (such as HIV and influenza) release nagalase. Nagalase blocks the production of GcMAF, thereby preventing your immune system from doing its job. With a deficient immune system, infections and cancer can develop unchecked.
The same research group has developed a treatment based on the GcMAF molecule. This treatment will activate your macrophages and boost your immune system, fighting off cancer and HIV. This treatment has also been implicated in autism, autoimmune diseases, and linked to a number of conspiracy theories [5, 7].
Low Nagalase: Schindler/Kanzaki Disease
Here is a fact: if your nagalase is not working (mainly due to genetic mutations) your glycolipids and glycopeptides, which are normally broken down by this enzyme, accumulate in your tissues. This results in Schindler disease, a metabolic disorder that causes issues with the nervous system. It can manifest in 3 different ways :
- Type I: a severe infantile neurodegenerative disorder; children don’t survive past early childhood
- Type II: adult-onset disease that leads to mild cognitive impairment and skin lesions (also known as Kanzaki disease)
- Type III: an intermediate form; people with this type display different symptoms including seizures, autism, and/or heart muscle disease
High Nagalase Levels
Studies have shown that nagalase levels increase in various diseases.
1) Viral Infections
Since cancer cells release this enzyme, people with prostate, cervical, breast, and other cancers have high levels of nagalase in their blood [5, 6, 9, 10, 11]. The more advanced the cancer, the higher the nagalase levels will be.
Nagalase activity is increased in children with autism .
Compared to healthy people, autoimmune patients with lupus have higher nagalase activity .
5) Excess Alcohol Consumption
In an observational study of 100 people, alcohol-dependent individuals had significantly elevated nagalase levels compared to healthy individuals. After detoxification therapy, their levels decreased .
The study suggests that alcohol abuse impairs the immune system .
Nagalase Testing – Too Good To Be True?
Nagalase testing and GcMAF treatment sound great, especially in the context of cancer. But are they too good to be true? There are significant red flags associated with the research.
GcMAF as a Cure-All
Here is the logic that the main research team used.
Nagalase suppresses the immune system, mainly by suppressing the production of GcMAF, the protein which activates our “Pac-Men” white blood cells. Hence, if we just give people GcMAF, their “Pac-Men” cells will activate and destroy all infections and cancer cells.
The team used the results of their studies support development of the miracle drug GcMAF. They have published research showing that treatment with GcMAF is effective for:
- Various cancers [5, 11, 6, 5] – most of the patients are cured
- HIV  – patients with HIV are cured for good
- MS  – GcMAF improves motor function
- Chronic fatigue 
- Autism  – GcMAF can potentially help with the suppressed immune system
Research Can’t be Reproduced
Most of nagalase and GcMAF research was done by a single person – Dr. Nobuto Yamamoto and a couple of questionable associates in the 90s.
If Dr Yamamoto and his colleagues had really uncovered such a golden ticket, other researchers would have followed, if not for funding, then for fame.
This hasn’t happened, but not because of a lack of trying. It turns out, other scientists had troubles reproducing the results .
If something works, it will work no matter who performs the research.
Unfortunately, when scientists fail to show evidence, excitement dissolves and and most journal publishers have no interest in the dull negative data. . Therefore, it’s reasonable to assume that many have tried working with nagalase over the years and none succeeded.
Retracted Papers and Questionable Methods
There are serious issues with Nagalase and GcMAF research. In fact, several of the articles published by Dr. Yamamoto have since been retracted, including the articles about HIV, breast, and colon cancer [7, 17, 18]. Retractions were due to scientific misconduct.
Here are a couple of issues with these and their other not yet retracted papers:
- They involved an extremely small number of patients, often in single digits.
- Patients in the GcMAF studies also received standard cancer treatment, such as surgery, chemo, or radiation therapy. This makes it hard if not impossible to tell if the patients were cured by the new drug or the standard treatment.
- Studies didn’t check the presence or progression of tumors by any other markers except for nagalase. There is no proof that GcMAF actually had an effect on cancer – there is only proof that it decreased nagalase levels .
- There is no proof that GcMAF works on the molecular level – no studies involving immune cells or cytokines. Studies make unfounded claims and falsely cite other studies .
- Research bodies, co-authors, and sponsors cited in these studies are nonexistent or were included without approval .
- These studies have no controls. This is a red flag for any kind of research.
No Success Stories
Nagalase studies date back to the ’90s, GcMAF studies to the ’00s with no recent quality research. It stands to reason if people treated a decade ago experienced a miraculous recovery, they would make this known and share it with other people desperately needing a cure.
But when you search for nagalase and GcMAF on the web, you will find doctors and companies recommending them. What you won’t find are actual people with success stories.
European organizations such as the UK Cancer Research and the Anticancer Fund warn against people and companies selling GcMAF .
Nagalase Blood Tests Marketed Today
Labs and doctors that advocate for this test say that nagalase levels are directly proportional to tumor burden. They suggest that this test can discover tumors before they are detectable .
However, although it’s said that this test is accurate for early cancer detection (this is the test’s main selling point), this makes no sense if this enzyme also increases in viral infections, autoimmune diseases, or simply when alcohol is consumed. If it doesn’t significantly increase solely due to cancer, nagalase can’t be a cancer screening method.
Some labs that have previously offered this test have since discontinued it, citing it as unreliable and not universally reflecting tumor burden.
If you do want to test your levels, by all means, you can do so. But don’t panic if the results come back elevated. Your immune system is often fighting various infections.
Studies report ranges from 0.23 to 0.39 nmol/min/mg in healthy individuals and up to 8 nmol/min/mg in cancer patients .
Note that other study groups had issues reproducing these ranges .
According to some research labs, normal levels are below 0.95 nmol/min/mg .
Prospects are Few
While nagalase and GcMAF may have a role in the immune system, the issue is that the studies involving them were seriously overblown.
At the moment, a company in Japan offers GcMAF treatment and another company in Israel has purchased the rights for developing GcMAF as a drug.
It’s not impossible that we will hear more about nagalase and GcMAF in the future, but the chances are slim.
Irregular Nagalase Levels?
If you have a level measured, you can assess your nagalase results with our LabTestAnalyzer. It informs you which labs are not in the optimal range and gives you guidance about how to get them to optimal. It also allows you to track your labs over time. No need to do thousands of hours of research on what to make of your lab tests.
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