Medivo, a provider of virtual healthcare services for individuals and organizations, announces that Dr. Destry Sulkes, physician and co-founder of Medivo, will discuss the value and importance of maintaining physician oversight and support for individuals requesting genetic laboratory tests. Dr. Sulkes will present his views today at the FDA/CDRH Public Meeting on Oversight of LDTs, in Hyattsville, Maryland.
As the popularity of LDT-based direct to consumer lab tests increases, so do the questions as to the safest and most effective communication channels between the individuals who requested the tests and their physicians. The intention behind allowing so-called enforcement discretion, or no formal review for the category of laboratory-developed tests (LDTs), was to facilitate local hospital labs in addressing the unmet needs with relatively simple tests that generated few risks and misinterpretations by physicians. Dr. Sulkes will discuss the growing importance of genetic testing, the variety and breadth of reports generated from genetic testing, and the role of medical professionals in helping individuals to understand their reports' impact on both their lifestyle and medical decisions.
"Genetic lab testing provides an invaluable service to individuals looking to gain insight and take charge of their health, and we are pleased to be presenting our perspectives on how physicians' involvement may help keep these tests safe and accessible," stated Dr. Sulkes.
While genetic laboratory testing has well established protocols and standards by the professional organizations who oversee them, the majority of the new genetic tests, many of which are LDTs, lack such standards. This field of testing is still largely in the research and development phase and given the variability in test types, lack of uniformity in testing protocols and the difficulty that can arise in interpreting these test results, strict physician oversight is essential.
Since 2001, Medivo, through its acquisition of Physicians Wellness Network, has offered virtual medical services when and where they are needed. To accomplish this, it relies on its access to a nationwide network of credentialed physicians who provide oversight services to individuals and organizations requesting lab tests. A secure online platform connects physicians with the labs to order the tests, and with individuals to review the results and address questions and concerns, thus helping to provide people with the tools they need to maintain good health.