3. Test Submission Requirements

Published 10/20/2023

Select the 'Add Test' action button from the Catalog Overview or My Diagnostics Exchange tabs within DEX®. Complete all required fields and submit for review. For more information, see the DEX Diagnostics Exchange Help Files.

When adding a test, use the tooltip buttons to identify required information and view helpful hints. For example, the Test Description should succinctly describe the test's intended use, indications for ordering, and limitations. PGx tests should include the intended drug(s) of interest in the description.

A DEX Z-Code identifier application is required for a single assay that may involve multiple tests in order to produce a single result. Ensure you enter your test as it is orderable to providers on your test requisition. A DEX Z-Code is assigned to individual orderable tests and/or panels and not to CPT® codes.

If the test process is standardized and the same method is used to acquire results in both locations, the lab will only have to submit one application for the test. However, if there is a difference in the method, a separate application will be required for both locations.

It is not necessary to apply for a new Z-Code when you make changes to a test. Please log into DEX and update the existing test record with the new information. If the changes are significant enough to constitute a new test, such as a methodology change or additional specimen types, a new Z-Code may be assigned.

Yes, in the event a test is retired, please update your DEX test submission to reflect this change. The DEX Registry relies on accurate data entry and maintenance. Please review the DEX Administrator FAQs (PDF) for specific instructions.

Yes, labs must register tests that include MDx and non-MDx range of codes in the test panel.

Yes, a Z-Code is required in both scenarios* but the process may differ for obtaining the Z-Code (see #9). The FDA approval and clearance processes ensure only the clinical and analytical validity of the test. The FDA does not include clinical utility in their review, which is required for a technical assessment.

*NOTE: At this time, molecular syndromic panels for infectious disease pathogen identification that are FDA-approved/cleared do not require a Z-Code unless the panel meets any of the criteria below:

  • If the FDA-approved/cleared test is being used outside of its intended use labeling (i.e., it is modified in any way) it requires a Z-Code.
  • If no specific CPT® or PLA code exists for the panel, it will be billed with CPT® code 87999. Molecular tests using CPT® code 87999 requires a Z-Code, regardless of FDA-approval/clearance status.
  • If you perform multiple (>1) FDA-approved/cleared molecular infectious disease pathogen identification tests on the same date of service (DOS), for the same intended use on the same patient sample, it is considered one distinct service and requires a Z-Code.

Refer to the Molecular Syndromic Panels for Infectious Disease FAQs for more information.

If the test is within scope of the program requirements, then both the manufacturer and the performing lab should register their organization in DEX. The manufacturer should follow the steps to add the test and obtain the Z-Code. Once that is complete, the performing lab can obtain the Z-Code through the Sharing function within the DEX Registry.

If a performing lab modifies an FDA-approved/cleared test in any way from its intended use labeling, the resulting test is considered a LDT (laboratory developed test) and the performing lab will need to add the test to the DEX Registry themselves.

The Z-Code can be obtained through the Sharing functionality in DEX if the following conditions are met:

  • The test is within scope of the program requirements.
  • The test performed is FDA-approved/cleared and unmodified. Note: If the test is being used in ways not consistent with its intended use labeling, then it is considered modified, and Sharing cannot be used.
  • The manufacturer of the test has registered in DEX and received a Z-Code.
  • Your organization is registered in DEX.

If these conditions are met, then you can Request Sharing with the manufacturer in the DEX Registry and access the DEX Z-Code.

If the manufacturer has not registered or added the test and therefore you are unable to use the Sharing function, then your organization may need to add the test. Contact us for assistance.

Yes, an application for a unique identifier will be required if the test has a CPT® code within scope for requiring a DEX Z-Code.

We recommend the laboratory wait until the FDA determination is complete to add that information to your test in DEX.

An algorithm may be considered a meaningful and independent component of a laboratory process when ALL the following conditions are met:

  • It is an unambiguous problem-solving operation that includes deploying a set of rules or calculations requiring computer processing;
  • The test result (or a component of the result) is the calculated output of this process, and not an intermediary process;
  • The same or similar test result could not be obtained without the use of this process;
  • The input for the computation is derived from biological samples using analytical processes, and must include data from the sample submitted for the test;
  • The process must:
    • Either be required for the analytical result, OR
    • If adjunct to the analytical result as a post-analytical process, the calculation itself must be independently found to be reasonable and necessary apart from the other components of the test.