Here are two entry points. First, on November 18, 2016, the FDA announced it was dropping for now its plans to regulate LDT diagnostics through guidance. Second, on February 1, 2017, a consortium of important organizations including the American Cancer Society and the American Society for Clinical Oncology wrote Senate leadership that something must be do to assure LDT laboratory quality (here).
So there's some tension out there - what will happen next?
Along the way, there is the "Quality Assurance Program for Companion Diagnostics," a multi stakeholder effort (leadership ranging from Abbott to Emery) to establish processes "by which all key stakeholders can be satisfactorily assured of molecular test equivalence across laboratories." Within the multi-purpose Tapestry organization, this is led by a Working Group called, "SPOT/Dx" - "Sustainable Predictive Oncology Therapeutics and Diagnostics." SPOT/Dx was launched by Tapestry in 2013.
For more information on the QAP-CDx, see these resources:
- Project homepage at Tapestry Networks, here.
- 15-page presentation by Barbara Zehnbauer, Emery, at AMP November 2016 (here).
- 3-page article by Zehnbauer et al. in Journal of Molecular Diagnostics, January 2017 (open access, here.).
- At the Tapestry website, a 4-page Q&A dated February 2017, here.
More after the break.
The program involves developing test reference samples, testing results with validating laboratories, and then sharing the results with a broader community and considering next-steps and scalability.
The program involves developing test reference samples, testing results with validating laboratories, and then sharing the results with a broader community and considering next-steps and scalability.
Discordance in genomic studies has recently been highlighted in terms of software tool variance (here), technology mode (e.g. paraffin sequencing vs liquid biopsy, here), and inter-lab variance (here). Even in 2017, some zones of the genome remain difficult to sequence well (here).
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Footnotes
In 2016, AMP launched a program called VITAL regarding variances between sequencing laboratories (here).
An article on Tapestry's new quality program is on the subscription site Dx360 (here), a sister publication to Genomeweb.
