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SPM member Janet Freeman-Daily, who’s an active voice in the #MedX and #LCSM communities, alerted us to a petition on that speaks directly to the principles of precision medicine – called for by the President in a White House event attended by our own Nick Dawson – and keeping the regulatory environment from standing in the way of actually delivering that precision medicine.

Quoting from the petition:

The FDA’s proposed “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” attempts to regulate LDTs as if they were self-contained devices (such as stents) or commercial test kits.  This won’t work.  Getting the best diagnostic and treatment outcomes from available specimens relies of the practice of medicine, which the FDA is not supposed to regulate.

The proposed regulations state that once a companion test kit obtains FDA approval, any modification to the test components or any change in specimen type requires separate FDA approval before the LDT can be offered to patients.  If no companion test exists for an oncogene, an LDT may offered to patients without obtaining FDA approval IF it is offered ONLY to patients in the same healthcare system as the laboratory that performs the test.

The proposed regulations require laboratories to submit all cancer-related LDTs for registration and listing.  In addition, LDTs for which a cleared or approved companion diagnostic exists (like BRAF-driven melanoma and ALK-driven NSCLC) must be submitted for financially prohibitive and lengthy premarket review.  Many labs, including those in major cancer centers (which currently offer hundreds of LDTs), might not have the deep pockets or other resources to seek FDA approval for their LDTs and would have to pull LDTs from their list of patient services, or even have to close.  This would impede not only access to potentially life-saving diagnostics, but impede innovation as well.

Hit the link in the first graf, head over to the site, and read the entire petition for yourself. Sign it, if you’re in favor of its principles.


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