Regulation of Laboratory Developed Tests in APAC

Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory for purposes of clinical diagnosis, and generally developed in response to emerging health needs. 

Yet there is no standard definition of an LDT across APAC markets. Regulation varies, as does the safety, accuracy and reliability of LDTs. Meanwhile, many rare diseases do not have any cleared In Vitro Diagnostics (IVDs), making it difficult for patients to get diagnosed. 

Our white paper, Regulation of Laboratory Developed Tests (LDTs) in APAC, produced with APACMed, looks at 14 APAC markets where in all but four markets LDTs are not defined in law. Only in Australia, China, Singapore and Taiwan are LDTs defined and regulated by the health authority through product market authorization, post-market surveillance, and quality management systems.

Definitions of LDTs in APAC

• China: In its LDT pilot program, China’s regulator states that an LDT can only be developed if there is no equivalent commercial IVD reagent on the domestic market. In addition, the LDT must demonstrate technical maturity with clear clinical significance.
• Australia: LDTs fall under the regulator’s IVD framework. They are called “in-house IVDs” and are defined as pathology tests that have been developed (or modified) and validated within a laboratory or laboratory network for testing on human samples for purposes of clinical diagnosis or clinical management.
• Singapore: LDTs are defined as IVDs used for clinical diagnostic that are developed and manufactured within a licensed clinical laboratory solely for use in the same laboratory.

European and US approach to LDTs

• United States: Historically, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS)—the agency responsible for the implementation of the Clinical Laboratories Improvement Amendments of 1988 (CLIA)—have asserted that the two agencies assert distinct but complementary regulatory authority over LDTs. At a high level, CLIA has various standards regarding quality and reliability of laboratory activities and facilities and their ability to measure certain substances and materials in biological specimens accurately and reliably (known as analytical validity) while FDA specializes in ensuring clinical utility or performance of medical devices or the accuracy with which such devices identify, measure, or predict the presence or absence of a clinical condition or predisposition in a patient (known as clinical validity). In May 2024, FDA stated that it intends to regulate LDTs as a subcategory of device IVDs generally subject to pre-market clearance or approval based on risk as well as post-market controls and certain quality system requirements. However, a federal district court held in March 2025 that FDA lacks statutory authority to regulate LDTs as medical devices entirely. In issuing this ruling, the court characterized LDTs as intangible “in-house diagnostic tests developed, validated, and performed by trained professionals within a single clinical laboratory” that are comprehensively regulated by CMS under CLIA. While the court acknowledged that the equipment, instruments, materials, and tools that laboratories use to perform LDTs may be medical devices regulated by FDA, it made clear that FDA lacks the authority to regulate LDTs themselves without a clear grant of authority from Congress.
• European Union: Define an LDT as a device that is manufactured and used only within a health institution established in the EU. The EU exempts LDTs from Medical Devices Regulation and In Vitro Devices Regulation (IVDR) requirements so long as they meet various conditions that relate mostly to compliance. The IVDR requirements will be phased in with full compliance expected by 26 May 2028.

Elements of a Risk-Based Regulatory Framework

Our White Paper proposed a risk-based regulatory framework for consideration by health authorities in the Asia Pacific region.  Key elements of a risk-based regulatory framework include the following.

• Clear Definition: Regulatory authorities should establish clear and harmonized definitions for LDTs. 
• Transparency and Accountability: Different stakeholders should be able to understand their roles and responsibilities in the lifecycle management of LDTs. 
• Co-Regulation: It may be appropriate to establish co-regulation between healthcare product authorities and laboratory authorities so that their responsibilities complement each other.
• Scope and Criteria: Regulatory authorities should consider local clinical needs and market dynamics when determining which types of LDTs would best benefit their patients, with the goal of balancing product availability and patient safety. 
• Pre-Market Pathway: Risk-based pathways for LDT regulation are recommended. 
• Product Quality: To produce reliable and effective LDTs, there should be quality control throughout the development, manufacturing, and testing processes. 
• Post-Market Surveillance: Risk-based post-market requirements, including adverse event reporting or quality, performance, or safety issue reporting, should be in place to ensure ongoing monitoring of LDT performance and safety.
• Pilot Programs: Markets that do not currently have clear LDT regulations can start with pilot programs to evaluate LDT availability and use in the local market. 
• Collaboration and Communication: Collaboration between government agencies, healthcare institutions and other stakeholders to help foster innovation, address regulatory challenges, and ensure that patients have access to safe and effective LDTs.

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