Genetic testing has the potential to modify the methods with which medical professionals approach disease detection, protection and treatment. Advancements in genetic testing in just the past few years alone have led to remarkable strides in cancer, hemophilia and cystic fibrosis, amongst others. Experts in genetic testing recently convened in Las Vegas at the MDx Next Conference in Las Vegas.
Richard Montagna, PhD, vice president for scientific affairs for Rheonix Inc., encouraged laboratory professionals to continue their research of genetic testing, create new methods that satisfy the clinical community and are cost-efficient for laboratories. "The focus of the conference was to look at the current status of companion diagnostics. But it includes not only the technology part, but the laboratory and the reimbursement hurdles of genetic testing," Montagna said.
The Cutting Edge
As Montagna explained, hospital laboratories that are considering an investment should know that while genetic testing comes with a high financial cost, the potential gains from investing in the research could put a hospital on the cutting edge of treatment and patient care, especially in companion diagnostics. This form of testing is unique in that it can predict if a particular patient will respond to a particular drug, thereby providing medically and cost-effective treatments.
It can also help to alleviate potential adverse side effects. Companion diagnostics is a very specific test developed to ensure the safe and effective use of the corresponding drugs. "All of this came to light from cancer therapies in some of the newer biologic drugs were developed for cancer," said Montagna. "A cancer patient deals with medications that cost tens of thousands per treatment regimen, and there's a chance that the drugs he or she is taking are not helping him or her get better. In some cases, the medication might be making him or her even worse."
Montagna noted drug companies noticed this alarming occurrence and paired with the FDA to amend the problem. These drugs were not efficacious in treating a fairly significant amount of people. These companies came to realize that their "one size fits all" production of medication needed to revolutionize. Just because two patients have the same disease doesn't mean that they can be treated with the same medications, he cautioned.
A Perfect Match
Montagna emphasized that companion diagnostics aim to treat a person, and not the general population. Genetic testing strives to pair the correct medications with the right patients. It is well known within the medical community that time is crucial when treating a malignant disease. Often times, the rate at which a medication will work can mean the difference between life and death. When a patient is critically ill, a physician does not have time to troubleshoot with medications. The outcomes can be predicted with genetic information.
Montagna explained, "We can stratify patients into potential responders and non-responders. As a result of that, the FDA has mandated that certain drugs have a corresponding companion diagnostic. So, a physician theoretically should not and cannot prescribe the drug unless the companion diagnostic has been performed."
People in the field of genetics are devoted to this science, so they are looking for ways to make the research affordable for all hospital laboratories. The aim of Montagna's presentation was to present hospital laboratories with simpler ways of training staff. The intricate nature of the research of genetic testing requires the thorough training of laboratory staff, Montagna explained.
He went on to elaborate that this training, while beneficial, comes at a great cost to a hospital. By spending more money on the training of staff, there is less money to spend on the necessary equipment, he noted. By developing methods that would not require as much training to handle the process, genetic testing could become much more routine.
"Current costs of various companion diagnostics tend to run in the several hundreds of dollars to several thousands of dollars," Montagna said. "Our automated platform will dramatically reduce the cost to considerably more affordable and cost-effective levels. Because of the manner with which we constructed this fully integrated system, the cost of this research can be dramatically reduced."
Improving a patient's long-term health and treatment is the driving force behind genetic testing. A gravely ill patient faces so many insurmountable odds on a daily basis. With genetic testing on his or her side, the light at the end of the tunnel may shine a little bit brighter. A patient could regain a sense of normalcy in a time when days are filled with chaotic disruption. Genetic testing puts both patients and physicians back in control.
When asked for final thoughts, Montagna offered, "The major outcome from a treatment standpoint is to give the right drug at the right time to the right person at the right dose. That's the goal."
Scott Hunt is a former intern at ADVANCE.