"Genetic Test Update"

Personalized Medicine: Meet Pathologists’ New Competitors

Silicon Valley and Wall Street are joining forces to develop next-generation diagnostic technologies

IF THERE IS ANY SINGLE “NEXT BIG THING” that will truly revolutionize healthcare, it is likely to be personalized medicine. This approach promises to deliver improved outcomes to individual patients, while helping to control—or even reduce—the cost of care.

Central to personalized medicine will be the need for the physician to have information about the patient’s DNA, RNA, and proteins. And the common expectation—at least for the foreseeable future—is that clinical labs and pathology laboratories will accept clinical specimens from the referring physician and perform these analyses.

However, such a scenario overlooks a major threat to the clinical labs and pathology groups now in operation. This threat was on public display last week at the annual Personalized Medicine World Conference (PMWC) that took place, appropriately enough, at the Computer History Museum in Mountain View, California.

Held in the heart of Silicon Valley, PMWC is a conference produced by Silicom Ventures and overlooked by the clinical laboratory testing industry. Over the course of two days, there were 75 presentations by healthcare leaders and business executives who are helping their organizations develop technologies and services to support personalized medicine. There were also formal presentations by 33 emerging companies that have some type of personalized medicine product or service under development.

I was one of more than 900 people in attendance. If there was one key insight which jumped out from these presentations and speeches, it had to be that Silicon Valley and Wall Street both recognize the profit potential in serving the needs of personalized medicine.

Wall Street and Silicon Valley

More importantly, these two communities are coming together. Wall Street is providing substantial capital and business expertise to a large number of high-energy, very smart scientists, entrepreneurs, and technology wonks. The common goal of these players from Silicon Valley and Wall Street is to develop the next big thing that advances personalized medicine and generates big profits.

My impression is that much of this activity is not on the radar screen of the clinical laboratory industry. But then, it is probably accurate to say that this activity is also unrecognized by most of the medical profession.

Over two days of presentations, networking, and conversations with other speakers and attendees, I came up with at least three primary insights.

First, there are really smart people developing some truly disruptive technologies. Obviously, understanding how to sequence, analyze, and understand DNA, RNA, and molecular material is a major area of research and development.

In a similar vein, another big area of development involves how information technology (IT) can be applied. Some well-financed enterprises want to apply IT to improve existing workflow in medicine. Others want to create improved access to medical/health information or to help researchers and physicians sift through clinical data to better understand how to diagnose and treat disease.

The common goal of these players from Silicon Valley and Wall Street is to develop the next big thing that advances personalized medicine and generates big profits.

Second, some companies are taking semiconductors and related technologies and applying them to diagnostics. At PMWC, a British company called DNAe (www.dnae.co.uk) discussed its gene point-of-care testing device. It is a semi-conductor chip that takes almost any DNA sample, then does prep, amplification, and the test. It requires one minute to handle, returns a result in 30 minutes, and the operator needs no advanced training.

The unique twist on this genetic POC testing device is that it uses a USB drive. This provides power to the device and allows the operator to use the computer screen and keyboard. Further, because the test is done on a semiconductor chip, the device transmits digital results.

Third, there are companies that want to use the Internet, social networking, and mobile devices to engage consumers and patients on aspects of healthcare. Think of health sites organized like Facebook and MySpace that help patients connect with other patients who also have their same disease and health condition.

One presentation was done by PatientsLikeMe.com. Currently, 128,990 patients have established their own page. PatientsLikeMe has structured information templates for 1,000 diseases and health conditions.

Sharing Experiences

It website states, “PatientsLikeMe is committed to putting patients first. We do this by providing a better, more effective way for you to share your real-world health experiences in order to help yourself, other patients like you and organizations that focus on your conditions.”

Throw HIPAA and patient privacy out the window! These patients are putting detailed medical histories on their pages. They want to learn anything they can from other patients who have the same condition.

At the same time, PatientsLikeMe.com’s detailed database enables anyone to use any combination of variables to drill down and find people exactly like themselves. For patients frustrated by an unresponsive traditional medical system, PatientsLikeMe gives them an instant way to get information that is useful to them.

Two Consequences

My fourth observation—and the most important—is that much of this activity is being led by people who are outside of traditional medicine. That will have at least two consequences.

One, some developers are naïve about the need to engage established medical professionals in the design and function of their products. Two, often these developers may not fully understand the barriers to acceptance that must be addressed as they launch their products and services into the clinical marketplace.

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