Before the Hulu deal, before the JLaw/McKay deal, and even before the Bad Blood book deal, there was a very narrow window in time when the established lab testing powers that be paused and asked themselves, “What if…?”

Make no mistake, everyone, and I mean everyone, in the in vitro diagnostic testing world assumed Elizabeth Holmes and, in turn, Theranos, were full of s**t. Despite the enormous hype and praise being showered on Holmes, including Woman of the Year (Glamour), Time magazine’s 100 Most Influential People, and Fortune’s Businessperson of the Year, people in the industry weren’t buying it. Why?

Because diagnostic testing is based on science, and science, unlike most other things in life, is driven by facts rather than perception. Transparency is not only a norm, it is a requirement. So, when Holmes preferred to deliver quips like, “I think that the minute you have a backup plan, you’ve admitted that you’re not going to succeed,” rather than data, the industry suspected. It didn’t know, but it suspected.

Nevertheless, in late April 2015, Theranos was nearing its peak valuation of $10b. Although then LabCorp CEO, David King, did not specifically cite Theranos as a reason for entering the direct-to-consumer testing space (I mean, why would he, really?), it seemed pretty clear that was the case.

This decision paved the way for the creation of a new consumer-facing business. Despite its enormous reach, LabCorp had never really ever engaged directly with consumers. Their core business depends on its relationships with healthcare providers and third party payers (insurance companies). Selling directly to consumers required a very different approach.

Without going into all the various factors and drivers that happened behind the scenes, the decision was made to build and launch an e-commerce website, selling at-home tests directly to consumers. Now technically, we still incorporated the use of a physician order to authorize the lab tests being purchased. As a result, we refer to this as “consumer-initiated” testing as opposed to true DTC testing.

Key members of our team led every aspect of building what would become Pixel by LabCorp, including: naming, branding, platform development, integration, incorporating a next-generation blood collection device, go-to-market, marketing and digital advertising, and kit package design, development, and fulfillment.

We ran Pixel as an internal startup. While we had responsibilities coordinating activity across the highly matrixed organization, including R&D, Legal, Ops, etc…, most of our activities happened independently of the core organization. For example, while many people might assume the platform itself was developed by the IT organization. It was not.

Without doubt, the greatest challenge we faced was validating the results of numerous target assays.

In October 2015, John Carreyrou, an investigational journalist for the Wall Street Journal, ran his first scathing report of Theranos. Over the subsequent months, as more of the truth came to light, a few things happened: first, Theranos completely imploded. In addition to FDA, CMS, and SEC investigations, the company lost prominent deals as well as subsequent funding opportunities. Eventually the company shut down, Holmes was tried and found guilty, and recently sentenced to 11 years in prison for committing multiple counts of fraud.

At the time, LabCorp, which is an extremely conservative organization at baseline, became even more cautious. This translated to enormous scrutiny in a number of areas, ranging from legal review of content, especially regarding explanation of test results - labs do not interpret, to validation of the tests themselves.

After numerous challenges related to the next-generation blood collection device and validation testing, we successfully validated a complete Lipid Panel and HbA1c assays, and launched the Pixel by LabCorp platform in November 2018.

Despite its limited capability at time of launch, Pixel by LabCorp became a household name during COVID-19, where it played a pivotal role in enabling remote testing.