Redefining diagnostics: An industry view

As the CEO of an emerging diagnostics company, I speak with patients and doctors on a regular basis, and am struck by how poorly the industry is serving their needs. The current patient experience is miserable.  We send sick patients to waiting rooms across town for additional testing, where they have tube after tube of blood drawn from their arms in order to perform tests they do not understand, at a price we do not divulge.  This process is shrouded in secrecy and a burden on our patients.

Test results trickle into the doctor’s office over the coming days, and sometimes weeks, where they will be held in strict confidence, even from the patient. I often hear patients recount the impact of the stress they undergo while waiting for tests to return.  Frequent calls to the doctor’s office, incomplete information, days passing and worry escalating.

{mosads}The process is indisputably broken, and solving these problems is a long overdue challenge of our industry. At a time like this, a single company can become the standard bearer—the proverbial face—of a movement.  And when that company’s work is called into question, many are quick to dismiss industry advancements altogether, overlooking the contributions, achievements and – most importantly – the potential of others in the field.

Make no mistake: the diagnostics industry is going to change dramatically in the next few years.  Indeed, it already is.  Small companies you’ve probably never heard of are innovating – creating new technologies that meet or even surpasses industry standards.  Some of these advancements are impacting mainstream healthcare today. 

Supercomputers and big data analytics are already improving patient flow in hospitals.  Networking and cloud technologies are working to make electronic medical records ever more effective, and will succeed despite a somewhat clunky start.  Genome sequencing is approaching mainstream utility at a rapid pace.  And new technologies in diagnostics, such as that in development at my company, are able to perform complex and thorough analysis of blood samples in mere minutes. 

Imagine a world where a small drop of blood will be taken from your finger at the doctor’s office during your appointment. The doctor will be able to electronically access the results she needs from within your records minutes later – all while you are speaking with him or her, face to face. No more second, third and fourth appointments, trekking to labs for bloodwork in between.  Imagine never again hearing “we’ll call in your prescription after your blood work comes in,” or, worse, “we’re going to run some tests for that serious disease and have you back in a few weeks to discuss the results.” 

These advancements are already in reach, and stand on the shoulders of innovations from the tech boom that are only now impacting mainstream medicine.  But unlike pure technology innovation, which can be released with bugs and glitches, refined over time, diagnostic technology needs to be innovated with the utmost concern for patient safety. The broader community involved in diagnostic innovation understands this concern, and it is important that we are not deterred by recent missteps nor conclude, erroneously, that the revolution in diagnostics is dead.

A few weeks ago, a brave woman stood in front of me and recounted the serious disease she lives with and that is, thankfully, in check.  But when she spoke of the endless tubes of blood taken from her veins over many trips to the lab, and the agonizing waits for results each time, she broke into tears.  We have created a diagnostic experience that provokes fear and anxiety in our patients, independent of their eventual diagnosis.

Thus the Theranos story strikes a chord, and with good reason.  The current diagnostic system is broken, and we can do much better. The good news is that there are a number of companies, mine included, that aim to solve these issues for our patients.  I call on the laboratory diagnostics community, lawmakers and regulators to work together with industry to expeditiously and safely usher in much needed change. As with any new frontier, there will be hype, there will be unicorns, and there will be losers.  But the real winners in this diagnostics revolution will be our patients.

Gunn is founder, president and CEO of Genalyte, a San Diego-based biotechnology firm.



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