Technology

The Xenomics Technology
Medical science knows that more than a hundred billion cells are eliminated each day from a normal healthy body. The nucleic acids (DNA and RNA) from each of these cells is broken into smaller pieces which are then disposed of in a variety of ways. Most of these DNA fragments are carried away by the blood stream that perfuses every tissue and organ of the body. Scientists at Xenomics were the first to discover that, contrary to expectations, a large portion of those fragments actually passes through the kidneys and appears in the urine. It is now established that urine contains genetic DNA markers representing cells, tissues, and organs from throughout the entire body. Of special interest to medical diagnostics is the fact that many DNA fragments detectable in urine come from viruses, bacteria, and other infectious organisms in the body. Similarly, tumor-specific genetic markers may be detected in urine as would markers from genetically distinct transplanted cells, tissues or organs. During pregnancy the developing fetus produces similar DNA fragments that pass into the mother’s blood stream and may be found in urine specimens as early as the seventh week of pregnancy.

In short, specimens of urine are now known to contain a wealth of genetic information regarding what is present in the body. This means more sensitive and earlier detection of many diseases may be possible. Tumors and metastatic cancer may be detectable much more effectively and earlier than before. This may mean that genetically distinct stem cells and transplanted organs may be monitored more frequently and more safely than currently possible using blood or biopsy tests. This also means that a broad array of molecular diagnostics may be performed on a single laboratory platform that is safer and more efficient than those currently used.

Xenomics´ patented proprietary technology utilizes this fragmented DNA material which has crossed the kidney barrier (hereafter referred to as transrenal DNA or Tr-DNA) and is available in urine to provide vital diagnostic information about conditions throughout the body.

The Traditional Technology
Current molecular diagnostic testing technologies are based upon blood, sputum, and tissue samples (typically biopsies) which are not only hazardous to obtain and handle, but are often not sufficiently sensitive or specific, and frequently difficult to automate. Further, most of those samples do not contain genetic markers from tissues and organs located elsewhere in the body.

Advantages of the Xenomics Technology
A particularly important feature of Tr-DNA diagnostic technology is that it is a true platform technology. This means that a single laboratory testing procedure designed to detect specific DNA biomarkers can be used to detect many forms of infectious diseases, cancer, transplanted cells and organs, or even prenatal detection of genetic markers of a fetus.

Tr-DNA tests are based upon a simple proprietary method of DNA isolation, followed by detection of DNA fragments bearing specific genetic markers. The detection methods and techniques are already well known and proven in molecular diagnostics laboratories where they are used to detect DNA in blood and a wide variety of specimens. Now these techniques are readily applied to the detection of Tr-DNA markers isolated from urine specimens. Thus, Tr-DNA technology may be applied to detecting and monitoring an extremely broad spectrum of medical conditions.

Additional advantages include:

• The kidney acts as a filter and presents purified Tr-DNA in the urine and, therefore, simplifies the sample preparation and DNA isolation steps currently required in the laboratory by other testing methods.
• The collection procedure is non-invasive and, therefore:
• Does not require the involvement of trained medical staff, and
• Easily supports repeated tests when conditions require and results in no discomfort for the patient.
• The Xenomics technology utilizes existing analytical equipment readily available in diagnostic laboratories through the world. Any new capital spending would be limited.
• Tr-DNA is stable at room temperature for extended periods. DNA in blood and many other traditional samples are not.
• Test processing can often be easily automated.
• Although many clinical Tr-DNA tests are performed using only a few drops of urine, it is readily possible to isolate these markers from larger volumes and thus increase the sensitivity of the test. This cannot be done easily using blood or tissue specimens.
• In many instances, blood or sputum for detection of infectious diseases cannot be easily obtained from many patients such as small children or the elderly. Urine specimens are not often a problem.
• Blood and other bodily fluids are highly infectious by nature, urine is not.