2min chapter

Beursweek | Europa's waardevolste beursbedrijf zélf op crashdieet

Beurs | BNR

CHAPTER

Intro

Dit hoofdstuk behandelt actuele geopolitieke vraagstukken, zoals Donald Trump's plannen en de zoektocht naar vrede in Oekraïne. Tevens wordt er gepraat met een gast over de persoonlijke voorbereidingen voor de kerst en de effecten van een recent gepresenteerd bedrijfsjaarverslag.

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Transcript

Episode notes

Speaker 1

In recent years, there's been an explosion of so-called lab-developed tests, which are designed, manufactured, and used in the same facility and have been exempt from FDA oversight. In September, the FDA proposed to remove the sloopole. In particular, the agency mentioned LDTs false positive prenatal diagnoses of rare genetic disorders that, instead of delivering the peace of mind proposed, have thrown several expecting parents into a panic and even resulted in the abortion of a healthy fetus. It also cited were problems with LDTs in other contexts, such as inaccurate genetic testing that has led to ineffective or harmful cancer treatments. Soon, the FDA will decide whether to withdraw, revise, or finalize the rule.

Speaker 2

However, by considering the problem solved, as long as LDTs and non-LDTs are treated similarly, the FDA proposal obscures a fundamental mathematical limitation to testing, which too many patients and doctors are unaware of. Practically all tests, not just LDTs, carry the risk of false positives, which can render the results effectively useless when the condition is rare enough. For such conditions, many tests should only be used when additional risk factors or symptoms are present.