This is the transcript of the statement offered during the FDA’s hearing on Lab Developed Tests in Washington, DC on Tuesday.  View the archived video version on the FDA website (Day two, approximately 2:30 PM EST).

I am Destry Sulkes, a physician and co-founder of Medivo, Inc., and also a volunteer Board Director of the non-profit, 501c(3) Alliance for CME.

I am here to discuss the issues surrounding “Direct to Consumer” or “DTC” healthcare practices as they relate to genetic lab testing, laboratory developed tests (LDTs), and physician oversight. My statements are based, in part, on my daily interaction with patients and healthcare providers as a physician and a principal of Medivo.

Since 2001 our company has provided virtual healthcare services when and where they are needed. One such service is providing independent physician oversight for a variety of organizations that receive lab test requests from individuals. This oversight is conducted safely and securely by our nation-wide network of credentialed physicians via telephonic access and over an online platform. In addition, as a result of the rapid growth of LDTs in genetic lab testing, we rely on publicly-funded medical education programs, like those from the Centers for Disease Control (CDC) and the National Institutes of Health (NIH), to identify and increase genetics communications competencies for our physicians, as defined by the National Coalition for Health Professional Education in Genetics (NCHPEG) .

I would like to provide some clarity on terms used widely and, unfortunately, interchangeably in the industry. The term “Direct to Consumer” or “DTC” was used in 1997 by the FDA to describe a method of advertising that provides valuable product information and increases consumer awareness, and not for consumers to to bypass their physician to directly obtain a prescription medication, nor a device whose use is restricted to medical professionals.

In contrast, the term “Direct Access Testing” describes a different process where some states have allowed individuals to order a limited set of the safest and most well-established lab tests from a CLIA-approved lab, which analyzes a patient’s specimen, without a request nor requirement for a physician’s order. Inidividuals can also purchase certain lab tests in a retail setting, when approved by the FDA, and used at home, like pregnancy tests or glucose meters. These tests are termed “Over the Counter”, or “OTC”.

Confusion has arisen where DTC, when used to describe genetic lab testing, has come to mean that individuals may order their own tests, despite the fact that no state has approved a genetic test for “direct access”, nor has FDA ever approved genetic tests for OTC access. FDA has never reviewed a request for OTC status, and states will not consider them for “direct access” because this category of lab tests is still largely in a research stage of development, with the most challenging results to understand. Interpretation of the reports is difficult, even for physicians with knowledge of the patient’s full history and health context, and given the breadth of associations under study, research on their overall impact on health outcomes is inconclusive.

This is why we maintain that physician oversight is essential to safe and effective communication of genetic lab test results.While the genetic testing industry has well-established protocols and standards for genetic testing results as developed by the Medical Genetics sub-specialty of Internal Medicine, they focus largely on inborn errors of metabolism, hemoglobinopathies, chromosome abnormalities and neural tube defects, and a handful of drug response tests, but of course the majority of the new LDTs lack such standards.

So, given the variability in the categories of genetic tests, the rapid proliferation of organizations with genetic LDTs, the significant challenges to the tests’ interpretation, and the uncertainty around the impact of test results on patient health, independent physician oversight is instrumental and vitally important to protect public safety.

I want to share the impact of what we are talking about today from the view of a family physician colleague. One of her patients, a 25 year old woman, gets her genome tested for her birthday. Her intent is to use the information mainly for entertainment, but also to see if there are any risks for inherited disorders that she could pass on to her children. Her results come back and she has low genetic risks for many illnesses, but her results showed an increased risk for venous thromboembolism. This scared her into thinking she needed a preventive medication, so she called her doctor. Her doc immediately reviewed her medical and family histories, noted that she’d recently taken two cross-country flights with no ill effects, and counseled her that she was most likely in no immediate risk and did not prescribe any medications, though she would add the new risk information to her chart for ongoing management and is glad that she and the patient know more about what to expect in the future.

This brief anecdote is a good exampleo of how these genetic tests and LDTs have the potential to deliver tremendous healthcare value and continued access to them is an important goal. With the help of everyone here, we can create a solution that maintains and broadens the benefits to all of us and our families.

I would like to extend my thanks to the FDA for allowing me this time to present my views.