The extent to which the advantages of personalized medicine may be expressed can be seen in the case of the Nucleix Corporation.
Dr. Adam Wasserstrom, one of the three founding entrepreneurs of Nucleix, tells of the early stages: "When we established the company, we worked initially on an innovative project in the field of criminal identification. We came to the realization that on-site criminal DNA evidence can be falsified and we developed a method for ascertaining whether certain DNA traces are genuine or falsified, in other words, whether they originate from the physical body or were synthesized in the laboratory. The method developed leads us to our field of expertise – DNA methylation. During the next stage, we developed a test for cases of suspected rape that identifies whether or not a sample comes from real sperm. The test works fantastically well, faultlessly. However, we made a business decision to place that development on hold when we realized that this ability to identify tissues via methylation analysis could also be utilized to identify cancer. We immediately decided to harness our knowledge toward this objective."
"In general, the DNA sequence in all the cells of our body is almost identical. DNA Sequence identity leads to the question as to how different cells function differently if all the cells contain the same DNA. The method created is where the methylation enters the picture – this is one of the body's methods for providing different identities for different types of cells. In essence, this is a layer that sits above the DNA. CH3 molecules that sit on the letters 'C' in the genome that precede the letter 'G.' Each tissue possesses a unique methylation pattern."
"In cancer, there is a massive disruption of the methylation pattern: areas that were previously methylated become unmethylated and vice versa. To identify cancer, we need to overcome two challenging obstacles. The first is to determine cancerous molecules that comprise a significant minority compared to healthy molecules. A susceptible biochemical method is required to determine the cancerous DNA. We have succeeded in developing the method that, to the best of our knowledge, is the most sensitive in existence: we are capable of identifying one cancerous DNA molecule out of a background of 150 thousand healthy molecules."
"The second part of the equation is also to know where to look: you have to identify the informative signs that tell us whether a person is sick or healthy. Here we are faced with a giant-sized genome with more than 28 million potential signs of methylation, and we have to decide which to look at."
"Most of the areas in any person's genome, both healthy and sick people, are methylated, and we search for unmethylated signs in healthy people and methylated signs in sick patients to be able to distinguish between them. If there were an ideal indicator (biomarker) that was unmethylated among the entire healthy population and a methylated indicator among all the sick people, we would be able to identify cancer in 100% of cases. Unfortunately, there is no such biomarker. Therefore, because a single biomarker is not sufficient, we need to construct a panel – a group of biomarkers. This task is mainly bio-informatic, and that is something we know to do well."
"A few weeks ago, Nucleix completed a large clinical trial in Europe for our first test – a urine test for detecting bladder cancer under supervision. These are patients who had cancer in the past and were treated and are now tested to ascertain whether cancer has returned. We received European regulatory authorization (CE) and will soon begin selling the testing kit to laboratories. There is already a range of other molecular tests however our results are better than any other such test on the market."
"Another of our developments is a blood test for detecting lung cancer. In contrast to bladder cancer, lung cancer is the second most common and the most fatal of all cancers. In the majority of cases, lung cancer is detected at too late a stage, when it has already spread, and it is impossible to save the patients. If it were possible to detect the disease in its infancy, while still localized, there would be a much higher chance of saving them."
"A tremendous need exists here for a test that can identify cancer at an early stage. Our test is still under development, but we have received very promising results. We intend this test to be a genetic screening test for older people and smokers. Unlike tests for patients under supervision, genetic screening is conducted for individuals with no previous history of cancer and with no symptoms. We believe that we can identify many cases of cancer during its early stages, thereby saving many lives."