I want to request testing by your laboratory, what do I have to do for this?

You will need to contact your doctor. Please tell your doctor to visit our website and to download our test kit order form (USA or outside USA), fill and sign it and submit it to our office together with a copy of his/her medical license. After that we will send a test kit to your doctor’s office.

I am a doctor and it is the first time I am going to send you samples. Should I send you my medical license?

Yes, please submit a copy of your medical license to our office by fax or e-mail.

The instruction sheet for Nagalase says to stop immune stimulants prior to testing. However, these are part of the treatment for the patient. Will these immune stimulants affect the result if they are not stopped for testing?

The immune stimulants decrease the Nagalase activity. We advise to draw blood for the Nagalase test just before the immune stimulant medication is given. If this medication is given once a week, as is mostly the case, then this will pose no problem. However, if a one week interval is not possible: at least try to use the same time period each time to have the best follow up.

The instruction sheet for the Methylation Pathway Panel says to stop medication (if possible) prior to testing. What kind of medication should be discontinued and for what time?

It would be better to stop intake of vitamin B6 and B12 for 48 hours before the blood draw since the high intake of these vitamins may affect the results.

Nagalase – Health Diagnostics and Research Institute

Test for monitoring efficacy of therapy for cancer and certain viral infections

Nagalase in serum / plasma

The test measures the activity of an enzyme α-N-acetylgalactosaminidase (nagalase) in blood.

Nagalase is an extracellular matrix-degrading enzyme that is secreted by cancerous cells in the process of tumor invasion. It is also an intrinsic component of the envelope protein of various virions, such as HIV and the influenza virus. Thus, it is also secreted from virus-infected cells1,3,4.

Nagalase deglycosylates the vitamin D3-binding protein DBP (also known as Gc-protein). Gc-protein, which contains three sugars, is the precursor for the major macrophage-activating factor (MAF). By complete deglycosylation, Gc-protein can no longer be converted to MAF.

Normally, MAF is produced from the Gc-protein by sequential removal of the galactose and sialic acid without touching the remaining sugar N-acetylgalactosamine.

Macrophage activation for phagocytosis and antigen presentation is the first step in the immune development cascade. Lost precursor activity, therefore, leads to immune suppression.

Increased nagalase activity has been detected in the blood of patients with a wide variety of cancers like cancer of the prostate, breast, colon, lung, esophagus, stomach, liver, pancreas, kidney, bladder, testis, uterus, and ovary, mesothelioma, melanoma, fibrosarcoma, glioblastoma, neuroblastoma, and various leukemias1,3,4. For various types of tumors, various levels of nagalase activity were found7. It appears that the secretory capacity of individual tumor tissue varies among tumor types depending upon tumor size, staging, and the degree of malignancy or invasiveness7. Increased nagalase activity has not been detected in the blood of healthy individuals1.

Nagalase activity is directly proportional to viable tumor burden1,2. Studies correlating nagalase levels with tumor burden suggest that the measurement of this enzyme can diagnose the presence of cancerous lesions below levels detectable by other diagnostic means1. In research studies, nagalase activity decreased to near tumor-free control levels one day after surgical removal of primary tumors from cancer patients, suggesting that the half-life of nagalase is less than 24 hours1,6. The short half-life of nagalase is valuable for prognosis of the disease during various therapies1,5.

Test indications

Nagalase in blood is a sensitive test for monitoring the efficacy of therapy in cancer and certain viral infections, including HIV and recently HSV-1/2. Because of the short half-life of nagalase, the method is suitable for monitoring various types of therapy. The great sensitivity of the test may help the physician / oncologist in obtaining a better understanding of the therapy and to fine-tune the treatment.

NOTE: The values may be affected by certain drugs used in the five days preceding blood draw. Drug use must be indicated on the Questionnaire submitted with the Requisition Form.

References

Korbelik M, VR Naraparaju, N Yamamoto. The value of serum alpha-N-acetylgalactosaminidase measurement for the assessment of tumour response to radio- and photodynamic therapy. Br J Cancer, 77:1009-1014, 1998.
Reddi AL et al. Serum alpha-N-acetylgalactosaminidase is associated with diagnosis/prognosis of patients with squamous cell carcinoma of the uterine cervix. Cancer Lett, 158:61-64, 2000.
Yamamoto N and M Urade. Pathogenic significance of alpha-N-acetylgalactosaminidase activity found in the hemagglutinin of influenza virus. Microbes Infect, 7:674-681, 2005.
Yamamoto N, H Suyama, N Yamamoto. Immunotherapy for prostate cancer with Gc protein-derived macrophage activating factor (GcMAF). Transl Oncol, 1:65-72, 2008.
Yamamoto N et al. Therapeutic efficacy of vitamin D3-binding protein-derived macrophage activating factor for prostate, breast and colon cancers. Cancer Res Proc, 38:31, 1997.
Yamamoto et al. Deglycosylation of serum vitamin D3-binding protein leads to immunosuppression in cancer patients. Cancer Res, 56:2827-2831, 1996.