New regulatory guidelines released by Singapore’s Health Sciences Authority outline specific requirements required to register next-generation sequencing-based in vitro diagnostic tests, known as NGS IVDs, in the country.
The new registration regulations are designed to address rapid advances in genomic technology that pose a challenge to existing regulatory oversight. They apply to qualitative in vitro diagnostic tests that use targeted next-generation sequencing to help diagnose suspected germline disease, somatic mutation related disease, and cancer. They are generally categorized as Class C medical devices.
The new regulations include requirements of acceptable specimen types and interrogated regions of the genome to be used for the test to be specified and documented. And they limit the type of collection device that may be used, the minimum volume or quantity of sample, and the collection conditions that must be adhered to for sample stability between collection and use.