Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally.
To date, HSA has not directly overseen laboratory-developed tests (LDTs) – those tests developed in-house by Ministry of Health licensed laboratories for clinical diagnostic use solely within their own facilities. HSA now thinks it needs to regulate LDTs to ensure they meet essential manufacturing and efficacy standards.
Its 22-page guidelines feature examples of test systems that do and do not meet the definition of LDT. HSA does not classify research-use only tests and commercial IVDs that are used off-label or in modified procedures as LDTs. The guideline is informed by feedback received during a consultation held in summer…
