The FDA Is Not Giving Up on Regulating Laboratory-Developed Tests

Thanks to rosetrees I found this article on the battle over regulating testing here in the USA. It has some other ramifications I won't go into regarding the development of leading edge testing. As Diogenes has talked about the regulators have been asleep at the wheel for years regarding standards for testing both in Europe and the US. I'm eagerly awaiting the videos from the TUK conference so I can watch Diogenes' presentation.

"After the Food and Drug Administration (FDA) announced in 2010 its intention to regulate laboratory-developed tests (LDTs), lab advocacy groups, biotech companies, and even Congress pushed back so hard that by 2013, FDA leaders described their efforts as mired in politics and, at best, uncertain. Now, with a surprise announcement in July that FDA will proceed with plans to regulate LDTs followed by a draft guidance published October 3, a newly confident and determined FDA has hit the ground running."

This is a link rosetrees gave me that I had missed. It is a 2013 article by Dr. Thienpont in the AACC (American Association of Clinical Chemists) newsletter about the importance of harmonizing the Thyroid Function Tests and why that is critical for patient care. Thank you rosetrees. Dr. Thienpont addresses the magic number '10'. Harmonizing the Thyroid Function Tests will be an improvement but it will not solve the problem of the 'low index of individuality' that they all suffer from. PR

"Thyroid disease is common in the general population, and its prevalence increases with age. Because the signs and symptoms of the disease often resemble other disorders, before initiating treatment physicians need to determine whether the patient actually has thyroid disease or something else. The test most frequently ordered to test thyroid function is thyrotropin, commonly referred to as thyroid-stimulating hormone (TSH). Based on the functional interrelationship of the hypothalamus, pituitary gland, and thyroid, TSH should be elevated if the thyroid gland is not producing adequate thyroid hormone, and suppressed if it is producing too much (Figure 1). Today, however, we are beginning to realize that this well-established paradigm for TSH synthesis and release is an oversimplification."

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4 Replies

  • You can ask Jim Ronan to send you a copy yourself if TUK agrees. His email address is:

    <removed as PR4NOW has seen it>

    Simply ask him for a copy of the video of my presentation. Do you feel this a quicker way forward?

  • Diogenes, I appreciate your kind offer but for now I'd best follow protocol and wait to see what TUK is going to offer given the presentation was done under their auspices. I believe they are going to post them on the TUK site or their video library. I've had many wonderful educational discussions on this forum, many of them with you, and I wouldn't want to offend anyone by trying to shortcut the process. PR

  • Let us hope that they don't go further and restrict patient access to tests without going through a doctor. On some basis such as "patients couldn't possibly understand" or some other specious basis.

    I seem to remember there already are some such restrictions - California and New York?

  • Thanks again for a good article.

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