IVD, LDT, RUO

IVD (In Vitro Diagnostics)

• Definition: Test reagents and instruments for which regulatory authorities (PMDA/MHLW in Japan) have reviewed efficacy and safety and granted approval.
• Reference: https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/ivd/0003.html
• Major Regulations: PMD Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices).
• Usage Scenarios: Blood tests in health checkups, rapid influenza kits, standard cancer screenings, etc. More than 90% of medical care in Japan relies on these IVDs.

LDT (Laboratory Developed Test)

• Definition: Tests developed within medical facilities or sanitary inspection stations in response to clinical needs. A test that a specific laboratory (within a hospital or a specialized testing company) designs, verifies, and operates independently for use only within its own facility.
• Major Regulations: Medical Care Act, Act on Clinical Laboratory Technicians.
• Note on Regulations: In Japan, definitions and regulations are not clearly established, so they may be categorized as RUO (described below) in some cases; however, in the US, there are definitions, and laboratory quality accreditation is conducted.
• Reference (Japan):

• https://www.jpclt.org/news/detail/20240321140523/
• https://www.pmda.go.jp/files/000161910.pdf

• Reference (US):

• https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
• https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments

• Usage Scenarios: Cancer genomic medicine (pre-approval), genetic testing for rare diseases, latest overseas biomarker tests (e.g., PrecivityAD2).

RUO (Research Use Only)

• Definition: Products intended solely for scientific research, development, and investigation. Not intended for diagnosis, treatment, or prevention.
• Major Regulations: Not subject to regulation.
• Note on Regulations: There are no laws regulating RUO itself, but it is advisable to gather information by searching online for "research reagents" or similar terms. The following FDA information is provided for reference.
• Reference: https://www.fda.gov/media/87374/download?attachment
• Usage Scenarios: Pathophysiological research at universities, drug discovery screening by pharmaceutical companies, exploratory endpoints in clinical trials (data collection for future use).

Example of Step-up Social Implementation
By proceeding with commercialization in the order of RUO → LDT → IVD, it may be possible to generate revenue while acquiring data and advancing the development of IVD (In Vitro Diagnostics) during that period.

• RUO: Upon discovering that "this substance serves as a marker for a disease," apply for a patent and publish a paper, then provide it to researchers and others as a research reagent.
• LDT: Increase accuracy clinically, perform validation, and conduct testing business as an LDT. Accumulate clinical data during this period.
• IVD: To enable sales as a tangible product, obtain IVD approval/certification and sell to medical institutions, etc.

Others

• Regarding LDTs, regulations are advancing mainly in the US, so please ensure you obtain the latest information as appropriate.

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​©K.Kamitani