DISRUPTIVE MEDICINE

As the barrage of criticism mounts surrounding Theranos’ product offering it is important to see the forest amongst the trees. Any early-stage company will have growing pains, yet sometimes the longview benefits everyone. Personalized health metrics are the holy grail. By quantifying ourselves we can expose a disease’s root cause(s) earlier, personalize treatments, and improve outcomes all while decreasing health spending.

Keep in mind that while Obamacare (officially the Affordable Care Act) has increased healthcare insurance coverage, it has not lowered healthcare costs. The American healthcare establishment will understandably fight to maintain this status quo. Rushed patient-physician visits, over-utilized diagnostic testing, referral networks, inflated costs, and a lack of health record ownership. Patients continually overpay for the worst outcomes in the developed world. Yet this has been known — for years.

The current medical climate supports retroactive care — chronic conditions are to be accepted and managed over one’s lifetime. Mild symptoms that are not measured may manifest themselves beyond a curable threshold. Clearly, the best alternative is to empower patients with metrics. Personalized medicine prevents diseases from reaching debilitating levels.

All the while, medical device manufacturers — the firms developing the tomorrow’s technology — are being held to a higher standard. Manufacturers must demonstrate improved clinical outcomes in hopes of obtaining reimbursement codes and physician adoption. Compounding these commercialization hurdles is public perception, which can distort the inconvenient truth.

Like many other companies, Theranos runs several Clinical Laboratory Improvement Amendments (CLIA) laboratories that have been certified by the Center for Medicare and Medicaid Services (CMS).

https://www.cms.gov/apps/clia/clia_start.asp?CLIANum=&LabName=theranos&LState=ALL&GeoCity=&state=AK&GeoZip=&appType=%25&isSubmitted=clia2

The Food and Drug Administration (FDA) cleared them to test for the analyte, herpes simplex virus (HSV-1). Other CLIA-waived analytes can be measured by device systems designed by competitors.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm

These laboratories and devices have been vetted and therefore can accept samples for diagnostic testing. The point is that Americans need this type of disruptive innovation as the current healthcare model has become unsustainable. Public policy alone cannot solve the self-perpetuating, bloated system. Instead, early-stage innovators are sorely needed.

Healthcare is a universal right. Illuminating the metrics that quantify our beings should be, as well. Before we attack a disruptive innovator, we should examine the landscape and its power-brokers. After all, knowledge is power.

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