TRANSPERS JAMA Publication Is First to Examine Policy Implications of Emergence of New Model for Genetic Testing

Direct-to-consumer genetic testing (DTC) has exploded - but little attention has been paid to the emergence and impact of new models of genetic testing that fall in a middle ground between the DTC model and the traditional model - the "hybrid lab model." In a JAMA Viewpoint published today, TRANSPERS authors examine the growing influence of the hybrid model and the policy implications.

Hybrid lab models focus on increasing consumer access and offering low test prices but, unlike DTC labs, they still require a clinician to order the test. These types of labs have rarely been examined as a distinct entity and when they have, they are usually labeled and studied as if they were DTC labs even though they are quite different. As a result, there is confusion about the different approaches to testing and no evidence about their effects and potential benefits and risks despite their rapid growth. The emergence of the hybrid model has significant implications for everyone involved in genetic testing: "The traditional genetic diagnostic industry, as we know it, is dead."

We find that the hybrid model addresses a gap between the DTC and traditional lab models, and that this model may provide benefits but may also have unintended consequences. The genetic testing landscape is rapidly changing and it is important for consumers, clinicians, policy-makers, and insurers to understand these changes and recognize the implications of the hybrid lab model.