THE first 鈥済ene chip鈥� designed to predict how patients will respond to some drugs was launched in the US earlier this year with much fanfare. But the Food and Drug Administration has now asked its maker, Roche Diagnostics, to withdraw it pending formal evaluation.
The decision is likely to set a precedent for the red-hot field of pharmacogenomics: tailoring treatments to patients on the basis of their genetic make-up. Several companies are developing microarrays that detect genes or gene variants that determine whether a specific drug will work for an individual or whether they might suffer serious side effects. Some people might lack the liver enzyme needed to break down a specific drug, for instance, so they could not tolerate doses as high as those who make the enzyme.
What, if any, laws cover these kinds of microarray is unclear. While a few countries, such as Australia, have introduced regulations covering genetic tests, most, including the UK, have only made recommendations. In the US, if a company markets a diagnostic test, it is subject to FDA review. But the scientific tools used to perform diagnostic tests do not need approval. Roche, which is based in Basle, Switzerland, launched the microarray in June without submitting it for approval, arguing that it fell in the tool category.
Advertisement
Now, the FDA has put its foot down. In a letter made public on 4 November it has told the company to stop marketing the chip on the grounds that it has novel technical features and its use has serious implications for patients鈥� health. It could take several months before the chip is approved.
In the European Union Roche will have to apply for approval in each member state. There is no single agency in the EU for evaluating medical devices as there is for drugs.