Forget the App; There’s a Test for That

by Greg Lundell

How many of you have had your blood taken during an annual exam?  That’s right, the yearly blood test.  It’s relatively standard these days to get a report detailing your Complete Blood Count (CBC) that tells you how many red and white blood cells and platelets you have pumping around, and your levels of iron.  Add to that the standard blood chemistry assays which test for blood urea nitrogen (BUN), carbon dioxide (CO2), creatinine, glucose, and potassium, chloride, and sodium, and you have quite a snapshot of your health.  (Check online for reference levels and what each test tells you; there’s a lot of useful resources.)
What’s relatively new and interesting in the healthcare field, however, aren’t those standard tests that have been around for decades, but the newer, more complex assays.  There are three relatively interesting growth points in the diagnostics industry right now; companion diagnostics, genetic testing, and biomarker tests.
Companion diagnostics were almost forced on the pharma industry, and for good reason. When a pharma giant brings a drug to market, they have to conduct a bunch of clinical trials, eventually including humans.  Throughout the years, the FDA and these companies learned that just because a drug was doing what it was supposed to, that didn’t mean it wasn’t ending up somewhere that was less than ideal.  Or the concentrations were too high or too low for certain people based on their individual metabolism.
The idea of testing for the amount of drug in an individual gained popularity; how much of a drug is in their bloodstream, or liver, or in a cancerous mass.  The FDA soon started requiring testing, and the pharma industry initially partnered with others to make the diagnostic tests.  That is until they realized they could sell the test and the drug; double the income.  Companion diagnostics were born, and now most new drugs are accompanied by a blood test to either screen the patient’s health prior to using the drug, or for levels of the active drug in the body. Those tests are actually a required part of the treatment in some cases.
Genetic testing is well known to individuals with a family history of certain diseases.  A large diagnostics company has a line of genetic screening assays on the market that test for certain genes that predispose you to certain cancers.  Their most popular is for breast cancer and utilizes a specific genetic mutation in the BRCA1 and BRCA2 genes.  If you have the mutation, you’re more likely to get breast cancer at some point during your life than those who do not.  This allows you to drive your own future, and individuals who test positive for the mutations then are urged to undergo more frequent cancer screenings.  Some even opt for a preemptive double mastectomy.  Knowledge, in this case, is innately very powerful.
Biomarker assays take it one step further.  Certain diseases, Alzheimer’s, for instance, are caused by a progressive change that takes place in your body that is not readily visible.  In the Alzheimer’s example, there are a number of proteins that exist in the fluid around our brain that are supposed to be there.  Our own neural cells make these proteins.  Research has shown that individuals who develop Alzheimer’s show a shift in these proteins, specifically in the ratio of one protein to another, that predicts your progression into having the disease.  Yet the only way to positively identify those with the disease is during an autopsy.
That’s exactly how it starts; some research figures out how something affecting our health happens.  Maybe eventually a drug will be developed to reverse or stop the changes that lead to Alzheimer’s.  In the meantime, a test will probably be first on the market to identify people with a higher likelihood of progression.  Then further studies on those people can help determine how we can fix it.
The future of diagnostics in healthcare was cemented years ago, yet innovation keeps pushing the realm of possibility into reality.  Add to that the sheer availability of most tests (they can be ordered online!), and the idea they now have assays that show the overall “age” of your cells (lookup telomere testing), life expectancy is sure to be above 100 before we know it.
This all leaves us with some interesting questions to ask of ourselves.  Do you want to know if that drug or therapy is working correctly?  The answer is most likely yes.  But on the other hand, would you want to know how your health will be in 10 or 20 or 30 years? Would you make any changes in your lifestyle now to possibly live longer or decrease your chances of disease?  Those questions are very personal, and the answers are probably as individualized as we are just being human.

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