Diagnosis of cancerous conditions
by ZMD GROUP
The human body consists of hundreds of billions of cells that are constantly being destroyed in the process of life, and these destroyed cells must constantly be replaced by new cells. This process of replacing destroyed cells is done by multiplication and differentiation (specialization) of stem cells. Therefore, at any given time in the human body, hundreds of billions of cells are continuously proliferating and differentiating.
During cell division, DNA replication occurs (i.e., the construction of two new DNA molecules from a single parent molecule), which involves many hundreds of thousands of atoms and molecules. Naturally, with such a large number of factors at play, the law of large numbers implies that defective DNA molecules will appear, containing defective genes. Even a DNA error rate of only 0.001% would lead to hundreds of thousands of cells with defective genes, including tumor cells of all types of cancer. This means that a few tens of thousands of cancer cells are constantly present in the human body.
As you can see from the scheme presented above, cancer cells are always present in our bodies, yet cancers do not develop if the oncolytic activity of the bacteria of the intestinal microflora is high. Therefore, the presence of cancer cells in a healthy body is normal.
An abnormal decrease of antitumor activity of the immune system results in cancerous conditions in which cancer cells have a chance to multiply and possibly lead to a cancerous tumor. The antitumor activity of the immune system depends on the oncolytic activity of the bacteria in our intestinal flora. If this activity is reduced, then the immune system is defective and cancers are inevitable, regardless of the treatment. Cancerous tumors appear only in cases where the patient’s immune system cannot eliminate all the newly formed cancer cells.
This phenomenon (the destruction of cancer cells by bacteria) is called the oncopolitical activity of bacteria. In the majority of cancer patients, the oncolytic activity of specific intestinal bacteria is below a certain limit (i.e., the cancer threshold). Furthermore, in those with no cancer, the oncolytic activity of bacteria is above this threshold.
Therefore, if the bacteria of the intestinal microflora exhibit a strong oncolytic activity, cancer does not appear, in spite of the constantly forming cancer cells in the body. If the oncolytic activity of these bacteria is reduced, the immune system is weakened and cancer becomes inevitable.
Thus, this approach opens a path for very early diagnosis of cancer, whereby cancer can be detected before the appearance of a visible tumor. For example, a lung-cancer tumor can grow to a size of about 1 cm in diameter in about five years. Such a tumor is almost impossible to detect reliably with x-ray or computed tomography scans. However, measuring the lytic activity of a patient’s intestinal bacteria can lead to a confident cancer diagnosis. Unfortunately, this method does not localize the cancer nor determine its size or type, but we can confidently determine whether the patient has the beginnings of a cancer that cannot be detected by visual methods. If the tumor is not detected by conventional means, the patient should be observed until the cancer is detected and localized. The patient could then undergo an operation in the early stages of the disease, relieving him or her from cancer. In addition, because the tumor would be detected when it is still small, this method should lead to an improvement in the treatment of cancer.
The results of these tests show that, to date, this method to diagnose cancer is the only method able to determine the cancerous state in any given person. If a person has a cancerous state, regardless of whether a cancerous tumor is detected, we can say with certainty that a cancer will be detected soon. Note that a broad category of patients has various tumors of unknown etiology. In these patients, although a cancer is suspected, its cancerous state is unknown, and the life of the patient depends on the accuracy of the subsequent diagnosis. In such cases, tumor biopsies look for tumor markers in the blood, and various studies using computed tomography and nuclear magnetic resonance are also applied. Unfortunately, the results of these studies are not always clear.
In addition, the effectiveness of anticancer treatment escapes any control. Many patients experience a relapse despite their anticancer treatment. The only way to obtain an accurate forecast and control the effectiveness of anticancer treatment is to determine the cancerous state of the patient as early as possible.
ZMD Diagnostics Ltd has set a goal of creating an automated system to measure the oncolytic activity of bacteria in the intestinal microflora, and to be able to make at least 10 000 measurements per day. To detect the presence or absence of cancer in a patient, knowledge of the state of his or her immune system suffices to determine the oncolytic activity of bacteria in the intestinal microflora.
Initially, our intention was to create a system founded on the reaction of bacteria to a culture of cancer cells, based on four-hour contact of the intestinal microflora bacteria with a culture of cancer cells. The number of surviving tumor cells would determine the presence or absence of a cancerous state. However, this method turned out to not be suitable for general clinical practice. Cancer cells are not user friendly and the measurement is very difficult to operate and calibrate. It is impossible to build a network of thousands of diagnostic laboratories that use this method, which remains an art as opposed to an industrial-strength process.
Therefore, ZMD has developed new methods to determine the oncolytic activity of bacteria in the intestinal microflora; methods that preclude the use of the very unreliable and capricious cancer cells. These new methods are based on measuring the activity of certain biological properties of these bacteria and have been developed in our laboratory and tested through the stages of validation and clinical studies. Preliminary results are very encouraging and inspire confidence in a significant clinical future. However, the methods remain a trade secret of ZMD and therefore cannot be presented yet to the general public.
The new methods are very simple and reliable and allow us not only to diagnose the cancerous state of patients in hospitals and in laboratory conditions, but also to monitor treatment at home. Therefore, we plan to produce two types of systems:
- System for hospital use;
- System for home use.
The system for laboratory use in hospitals is a bacteriological laboratory capable of analyzing about 10,000 fecal samples per day. A patient may pass a stool sample for analysis and receive an answer within 48 hours informing him of the state of his intestinal bacteria flora. From each stool sample, certain strains of bacteria are seeded and their biological parameters are measured, such as their rate of growth, their biochemical activity, etc. Based on the analysis of these data, a medical report is prepared outlining the cancerous state of the patient.
These figures may indicate not only the presence or absence of a cancerous state, but also the state of the immune system in general. If the growth rate of the bacteria and their biological activity are sufficient, the patient’s immune system is in order. If these numbers are lower than normal but higher than the critical condition for cancer, the functional state of the immune system has been reduced, which may correspond, for example, to individuals who are predisposed to a variety of infectious diseases such as Crohn’s disease and others. But they do not have a cancerous condition. If these figures are below the critical threshold, the patient has a cancerous condition.
The diagnostic system for home use is much simpler than the system for hospital use. Here, the relevant species of bacteria is selected by using the special selective-growth media. However, it is impossible to make a full selection of bacteria. Some of the bacteria from a given sample will be nonspecific for this sample, so they are stored for use in the measurement. In addition, the system only measures one type of vital activity of bacteria. Therefore, the measurement is less accurate than the hospital version and cannot be used for diagnoses.
This system is used only as an indicator to monitor the effectiveness of anticancer treatments based on the lytic activity of the onco-reducing bacteria. This means that any data obtained cannot be used as an argument to confirm or refute a diagnosis because the system does not diagnose certain specific bacteria. However, by being examined during a course of anticancer treatment, these data may suggest whether the treatment improves or weakens the immune system. And if such a likelihood exists, then a more detailed analysis of the patient’s condition is warranted.
For example, the same system can be used to track the state of the immune system of a patient during chemotherapy. If the functional state of the patient’s immune system remains constant or decreases, then the treatment likely has no therapeutic effect on the cancerous state, or may even enhances it, increasing the likelihood of cancer recurrence. If the biological activity of the bacteria increases, then the treatment likely has a favorable effect.
Currently such diagnostic systems are clinically tested but are not yet for sale. The cycle of clinical trials must be completed before obtaining the permission of the various ministries of health (FDA, CE, and others) to use this equipment in clinical practice.