Chat GPT and Claude review FDA 26 page summary of AvertD Genetic Panel (10/2022)

This is a Claude AI, and ChatGPT4, summary of the FDA's summary of the AvertD genetic panel adcomm at FDA 10/20/2022.  Document here.   My main blog here.

CLAUDE.AI

Here is a 5-sentence executive summary of the FDA workshop on the AvertD genetic test panel:

• The FDA convened a workshop with experts to review the AvertD genetic test panel, which aims to help assess risk of developing opioid use disorder (OUD). Experts reviewed the test's methodology, clinical study design, and performance data. 
• The panel voted 13-2 against approval, citing concerns about the clinical study population not matching the intended use population, categorical high/low risk results, potential for misuse, and lack of real-world implementation data. 
• The sponsor defended the test but was open to altering the labeling and risk categorization. Overall, the panel felt risks outweighed benefits and sought additional data and safeguards before considering approval.

10 Key Takeaways:

1. The AvertD test uses 15 genetic polymorphisms to assess OUD risk from prescription opioids for acute pain.
2. The test provides a categorical high or low OUD genetic risk result.
3. The clinical study design likely introduced significant bias by recruiting heavily from opioid treatment sites.
4. The study population was 92% white and had unclear comorbidity evaluations, raising concerns about generalizability.
5. The Panel was very concerned about potential harms from categorical high/low risk results leading to over-reliance, under-treatment, or stigma.
6. The Panel sought a more nuanced, continuous-scale risk output rather than binary high/low results.
7. There were uncertainties about whether the 15 SNPs appropriately and exclusively assess OUD genetic risk.
8. The Panel sought further safeguards against off-label use and clear limitations in labeling and education.
9. The vote was 13 no, 2 yes for approval, citing study biases, categorical results, and potential for misuse as main concerns.
10. The FDA and Panel emphasized that more data on real-world implementation is needed before approval should be considered.

ChatGPT 4

Same prompt: The FDA reviewed the use of this new genetic test panel to help manage opioid prescriptions and risks. They generate this 26 page workshop summary. Please provide an executive summary of the work shop, and then, please list 10 key takeaways from the meeting.

The 26-page FDA workshop summary details the review of a new genetic test panel, AvertD, by AutoGenomics for managing opioid prescriptions and risks. The workshop included presentations by the FDA, sponsor (SOLVD Health), and public opinions. Key discussion points revolved around AvertD's design, its use of 15 SNPs to assess genetic risk for Opioid Use Disorder (OUD), study design concerns, and its potential impact on clinical practices. The panel critically evaluated the test's effectiveness, data representation, and implications for patient care, considering both benefits and risks.

Key takeaways from the meeting include:

1. AvertD's Purpose: AvertD is designed to assess genetic risk for developing OUD, to aid in decision-making regarding opioid prescriptions.
2. Test Design: The test evaluates 15 SNPs associated with OUD, using a cheek swab sample processed in a CLIA-certified lab.
3. FDA Concerns: The FDA raised concerns about the study design, including subject recruitment and the representation of the study population.
4. Sensitivity and Specificity: AvertD reported 82.76% sensitivity and 79.23% specificity in the clinical study.
5. Study Population Representation: Doubts were raised about whether the study population adequately represents the intended use population.
6. Risk of OUD and Comorbidities: There were discussions on whether the test could distinguish between OUD risk and other comorbidities.
7. Public Opinion: Varied opinions were presented during the public hearing, emphasizing both potential benefits and risks.
8. Panel's Concerns: Panel members expressed concerns about the risk of under-prescribing opioids, potential stigma, and reliance on genetic testing.
9. Data Gaps and Further Studies: The need for further studies and more data, especially regarding different subpopulations, was highlighted.
10. Labeling and Usage Guidance: Suggestions were made to refine the labeling to avoid over-reliance on the test and to guide its appropriate use