Xenomcis Takes Aim at Amniocentisis With Transrenal DNA
Like many biotech breakthroughs, this particular technology has its roots in a 20 year old discovery. In 1986, Dr. Samuil Umansky was working for the Russian Health Ministry and doing clinical research on the radiation poisoning from the Chenobyl disaster.
Dr. Umansky discovered that radiation poison could be detected in urine. In order to be in urine, the radiation had to survive the kidney's highly effective cleansing process. The radiation poison was actually carried in the DNA. Until that discovery, the health sciences community never realized DNA could survive the kidneys and be passed out of the body in urine.
Hence the phrase "Transrenal DNA"- this is DNA which has been passed through the kidneys and can be detected and analyzed in urine.
Fast forward to 1996. Dr. Umansky is in the US, and has three patents concerning the use of Transrenal DNA. The three patents cover the applications of Transrenal DNA for use in transplantation, cancer, and early genetic testing of an unborn fetus.
The company, as it exists today, has been operating since last July. Despite being public since that time, XNOM has never made any effort to get its message out to investors. Therefore, you get the first look.
The company sees potential revenue generating applications in four areas for Transrenal DNA;
Infectious Disease Detection
Genetic Testing of an Unborn Fetus
XNOM has spent the last nine months gathering data in its lab facility in Princeton, NJ. Ten highly qualified scientists work there on a full time basis doing the foundational research.
To date, XNOM has successfully harvested over 300 samples, otherwise known as "data points" in the industry. They have identified alien DNA (DNA not from the mother) in 119 urine samples from pregnant women, and analyzed data points from 200 samples of cancer patients in a study conducted with Thomas Jefferson University.
XNOM is destined to end up on the radar screens of many investors in the coming months. XNOM is preparing to start clinical trials for an FDA Approval of its first application in April. Since this is a non-invasive urine test, XNOM need only demonstrate the product works. They don't have the same stringent requirements you would have with a new drug. Therefore, XNOM anticipates it will only take about 2 years to obtain the FDA Approval. Clinical data will be made available to the public markets thoughout the course of the studies.
XNOM is taking aim at the barbaric "AMNIOCENTESIS" test performed on pregnant women worldwide. In the US alone there are approximately 6.2 million pregnancies each year. Of those, 10% to 15% are considered high risk for genetic diseases such as Downs Syndrome, Sickle Cell Anemia, Tay Sachs, and Huntingtons.
Currently, most pregnant women undergo a three panel test to prescreen prior to amniocentesis. If the doctor and patient decide to move forward, the amniocentesis test is performed.
An eight inch needle is inserted into the pregnant women's abdomen. Barbaric for a simple test. It penetrates the amniotic sack, and a small amount of amniotic fluid is withdrawn. The test is highly invasive and very dangerous. About 1% of tests performed lead to negative complications.
The amniotic fluid contains fetal DNA, which can be tested for genetic diseases.
XNOM expects to begin clinical trials in April for a test which could make amniocentesis obsolete. The test will be designed to replace the three panel test doctors recommend before considering amniocentesis. Most pregnant women who receive medical care in the US take this test.
XNOM's patented technology has the capability of identifying the fetal DNA in the mother's urine. Once identified, the DNA can be tested for genetic diseases.
Down the road XNOM intends to develop cancer and organ transplantation tests using the patented Transrenal DNA. In transplantation the patient has tissue with someone else's DNA. Early rejection can be detected in DNA changes. DNA from tumors can also be detected. Early detection of colon, liver, and pancreatic cancer is also possible with Transrenal DNA.
Today, after the market closed, XNOM announced an exciting development out of its joint venture with the National Institute for Infectious Diseases in Italy known as Lazzaro Spallanzani. XNOMannounced clinical results that demonstrate for the first time the ability to detect tuberculosis DNA in the urine of HIV infected patients. This could lead to the development of tests which provide significant advantages over the current tests.
There is a lot more to cover with this company. The management team led by CEO Randy White is exemplary. Randy White's resume is extraordinary in the biotech industry. Thomas Adams serves on the board- he was the CTO at stock market superstar Hybritech, and the founder and Chairman of Gen Probe, Inc, the leader in blood screening technologies. We'll save that for future editions.
There is not much to say about the trading history of the stock. The little it has traded has been in the $4 range for the last six months. I have absolutely no idea where it will trade tomorrow. It closed today at $2.50. There are 16.5 million shares I&O according to their last SEC filing. This idea is only for long term investors who want to get in on the first look at unique and exciting new biotechnology. If you like the biotech sector, a small position in this stock is a must own for the speculative end of your portfolio.