Thomas Maeder
Tuesday, August 17, 2010 5:40 PM

Lab-Developed Tests vs In Vitro Diagnostics - Balancing patient safety, access, innovation, and commerce

On July 19 and 20, 2010, the Food and Drug Administration held a public meeting on regulatory oversight of laboratory-developed tests (LDTs). This is considered a major step in an ongoing debate on how best to handle two different, but often overlapping, sets of diagnostic tools in a manner that best serves patient safety and public health, while recognizing the realities of clinical practice and medical product development. 

Stakeholder interest was intense. The original meeting space reached capacity and registration closed within two days, prompting FDA to shift the conference to a larger venue. Nearly 650 people attended, while 650 more watched via webcast.  FDA’s sense of urgency on the matter was further suggested by the June 10 issuance of “it has come to our attention” letters to six genetic testing companies, followed by another 14 on the opening day of the conference itself.

What are the issues?  Why the concern?  What does it all mean, and where might the Agency go?

Once upon a time, medical diagnosis was a subtle art with simple tools—the sight, sounds, feel, even smell and taste of the patient, combined with personal and family history and the physician’s skill and experience. Even with the advent of more complex instruments, from stethoscopes and thermometers through scopes, monitors, and blood tests, the administration and interpretation of diagnostic procedures remained within the realm of medical practice, or at least within the treating more...

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