The future has arrived. The newest buzz word in medicine is “molecular diagnostics”. There isn’t even a standard definition in Wikipedia as yet, but as near as I can ascertain it is an emerging subdivision of medical pathology to identify various substructures in the human genome such as the DNA and RNA molecules from tissue samples or body fluid specimens that serve as identifiers of predispositions to or existence to various types of diseases. Roche Laboratories is already producing and marketing a new test called the “AmpliChip CYP450”. This is a test that allows a lab technician to study the DNA and RNA molecules of any patient and predict the rate of metabolism of any drug. This new area of medical technology has enormous implications because it takes the guess-work out of dosage calculation and selection. The physician will know exactly how much medication to prescribe to achieve the ideal therapeutic effect specifically for that patient.
Additionally, researchers are developing ways to perform DNA and RNA analyses to predict whether there would be any allergic reactions or toxic effects to any drug being considered for treatment. In the area of infectious disease, Seegene, a company in South Korea has announce its new multiplex PCR technology which uses DNA analysis to screen for multiple viral and bacterial infections with almost immediate results. As competition heats up in the race to market such innovations with faster and cheaper technology this has enormous implications in screening large numbers of people at airports and other ports of entry in all countries that receive an influx of tourists and immigrants.
In other clinical areas, GenMark has developed four diagnostic tests for use with their XT-8 System, including a Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test and Thrombophilia Risk Test which have received clearance from the Food and Drug Administration. The latter two test will be useful in selecting the maximum effective dosage of Warfarin (blood thinner) specific to the patient’s DNA to prevent the formation of blood clots in the legs that can lead to pulmonary emboli (blood clots in the lungs), which is a life-threatening condition.
Although there are possibilities for substantially reducing the toxic effects of the trial and error approach in prescribing medications, we are going to be dealing with a double-edged sword. The potential downside to this new technology is DNA profiling. As of now the criminal justice system is using such data bases for convicted sexual predators and other types of convicted felons. However the potential for expanding this type of medical record to the entire population is growing exponentially as the technology becomes cheaper and easier to use. In the not too distant future governments will be able to keep the complete genome profile of hundreds of millions of people recorded in a microchip the size of a shirt button. Certainly, we have privacy laws like HIPPA that are designed to prevent unauthorized access to medical records. On the other hand, federal laws are only as effective as the politicians’ will to enforce them. Thus far, the political leaders of this great country have a dismally poor track record in the enforcement department; especially regarding immigration laws.
In conclusion, molecular diagnostics is undoubtedly the next level of cutting-edge medical technology, making for some attractive investment opportunities. However, we the people are also facing a concomitant danger of being subjected to control and abuse by unscrupulous politicians. The new health care law requires funding for setting up a centralized medical records data base. At present patients and doctors can still choose to keep certain private information from being entered in the central files. However, with DNA profiling, there is no way to filter out data that would cause prospective employers to deem an applicant undesirable for medical reasons. As our government continues to gain more control over private enterprise, one has to wonder if molecular diagnostics can also become the next Pandora’s box.