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Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

The next chapter in the ctDNA story: Still promising, not ready for prime time A recent workshop summed up the state of play for circulating tumor DNA. As dying cancer cells degrade, their cell contents are released into the patient’s circulation, affording the possibility of detecting fragments of DNA that are unique to the cancer.

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

Predictive biomarkers enable the identification and selection of patients who are more likely to benefit from a specific treatment and would achieve a better clinical outcome in response to a specific treatment. Prognostic biomarkers enable patient selection that would have a better clinical outcome irrespective of treatment.