Dx Regulatory Pathways in the US | Diaceutics

Dx Regulatory Pathways in the US


This case study considers whether the test required to enable a therapy should be an LDT or an IVD kit and explains their different regulatory pathways. It will help you understand:
  • Whether the test required to enable a therapy should be an LDT or an IVD kit
  • The role and importance of a Target Test Profile (TTP)
  • How the TTP will point towards an LDT or an IVD kit
Download this case study to learn more.

1: Case Summary

This case will help you understand:

Whether the test required to enable a therapy should be a laboratory developed test (LDT) or an in vitro diagnostic (IVD) kit.

The role and importance of a Target Test Profile (TTP).

How the TTP points towards an LDT or and IVD kit.

Key messages:

US laboratories that develop and validate their own in-house diagnostic test (LDT) must comply with the Clinical Laboratory Improvement Amendments (CLIA) regulations.

Diagnostic kits developed, manufactured and validated by a diagnostic company must be reviewed by the FDA prior to their launch.

Defining the key parameters for the test will point you towards an LDT or IVD kit.

Key actions:

Define key test parameters for your test to inform the regulatory pathway.

2: Background to Tests and Regulations

So What?

Laboratories that develop and validate their own in-house diagnostic test (LDT) must comply with Clinical Laboratory Improvement Amendments (CLIA) regulations.

Diagnostic kits developed, manufactured and validated by a diagnostic company must be reviewed by the FDA prior to their launch.

Commentary

Laboratory developed tests (LDTs) are tests developed and validated in-house and are not currently regulated by the FDA. Instead LDTs have to comply with CLIA requirements.

In vitro diagnostic test kits (IVDs) manufactured by a diagnostic company for sale to multiple laboratories are always regulated by a local agency such as the FDA, CE or SFDA.

3: Comparing LDT and IVD Kits

*Proposal by FDA to regulate LDTs, with an immediate focus on high risk tests including companion diagnostic tests​.

 Lab Developed Test (LDT)IVD Kit
Development / Manufacture Laboratory IVD kit manufacture
Quality Assurance Compliance with CLIA Compliant with FDA requirements
Commercial Distribution In-house use only Requires regulatory authorization
Marketing / Promotion Not permitted Requires regulatory authorization
Reimbursement Possible Possible
So What?

Defining the key parameters for the test will point you towards an LDT or IVD kit.

Commentary

Currently, an LDT might be chosen to lower the development costs or accelerate the time to market, and an FDA-approved IVD kit might be chosen to ensure a favourable review from payers or enable specific promotional claims.

Pharmaceutical companies have started to petition the FDA to have all pharmacogenetic tests regulated.

4: Proposed Regulatory Changes for ​Laboratory Developed Tests


So What?
With the increasing requirements associated with having an FDA review and approval/clearance of companion diagnostic tests, laboratories may not develop such tests. Consequently, the broad availability of companion diagnostic tests to support therapy prescription may be reduced, requiring adoption of FDA-regulated IVD manufactured tests.  ​
Commentary
While the FDA has always claimed it has the authority to regulate LDTs, it has long exercised 'enforcement discretion' over them. ​(LDTs are designed, manufactured and used within a single lab.​)
 
The FDA proposed a risk-based regulatory framework. For Class II and Class III LDTs, or moderate- to high-risk tests, the FDA will phase in registration, listing and adverse events reporting, as well as 510(k) and pre-market review requirements over a nine-year period. [2015] ​

5: Key Messages

Key messages:

US laboratories that develop and validate their own in-house diagnostic test (LDT) must comply with the Clinical Laboratory Improvement Amendments (CLIA) regulations.

Diagnostic kits developed, manufactured and validated by a diagnostic company must be reviewed by the FDA prior to their launch.

Defining the key parameters for the test will point you towards an LDT or IVD kit.

Key actions:

Define key test parameters for your test to inform the regulatory pathway.

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