Lab-Developed Tests Under FDA Scrutiny: What It Means For Startups
Portfolio Pulse from Vandana Singh
The FDA has proposed a regulatory shift that would require lab-developed tests to be reviewed before they can be sold. This move has created uncertainty in the laboratory-testing market, potentially affecting startups that are developing tests to detect diseases earlier and personalize treatments. The FDA's concerns are based on the efficacy of lab-developed tests, which have led to over- or under-treatment for heart disease, inappropriate therapies, and incorrect diagnoses of diseases, including Alzheimer's.
October 05, 2023 | 1:06 pm
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NEGATIVE IMPACT
The proposed FDA regulation on lab-developed tests could impact AGNG, as it may affect the speed and cost of introducing new diagnostics.
AGNG, being in the healthcare sector, could be affected by the proposed FDA regulation. If the regulation is implemented, it could slow down the introduction of new diagnostics and increase their cost, which could negatively impact AGNG's performance.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 75
NEGATIVE IMPACT
The proposed FDA regulation on lab-developed tests could impact FHLC, as it may affect the speed and cost of introducing new diagnostics.
FHLC, being in the healthcare sector, could be affected by the proposed FDA regulation. If the regulation is implemented, it could slow down the introduction of new diagnostics and increase their cost, which could negatively impact FHLC's performance.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 75
NEGATIVE IMPACT
The proposed FDA regulation on lab-developed tests could impact FXH, as it may affect the speed and cost of introducing new diagnostics.
FXH, being in the healthcare sector, could be affected by the proposed FDA regulation. If the regulation is implemented, it could slow down the introduction of new diagnostics and increase their cost, which could negatively impact FXH's performance.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 75
NEGATIVE IMPACT
The proposed FDA regulation on lab-developed tests could impact IYH, as it may affect the speed and cost of introducing new diagnostics.
IYH, being in the healthcare sector, could be affected by the proposed FDA regulation. If the regulation is implemented, it could slow down the introduction of new diagnostics and increase their cost, which could negatively impact IYH's performance.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 75
NEGATIVE IMPACT
The proposed FDA regulation on lab-developed tests could impact VHT, as it may affect the speed and cost of introducing new diagnostics.
VHT, being in the healthcare sector, could be affected by the proposed FDA regulation. If the regulation is implemented, it could slow down the introduction of new diagnostics and increase their cost, which could negatively impact VHT's performance.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 75