Email from head of diagnostics division. From ba
Post# of 30028
Posted On: 08/14/2014 10:55:15 PM
Email from head of diagnostics division. From back in April 2014
Gerald has asked that I answer your question regarding the timing to launch the LymPro assay under CLIA regs. If we partner with an existing clinical laboratory to implement and offer LymPro as a laboratory developed test (LDT), there is no formal application required. The test must be validated in the partner clinical lab and then the lab sends an updated test menu document to the appropriate regulatory body (state or federal, depending on the state in which the lab is located). The test menu would indicate that the lab is now offering the LymPro test. Once that is done the lab may offer LymPro.
The lab will need to have a complete development and validation package on file, as the CLIA inspector will usually ask to review it at the next scheduled inspection. If the inspector is satisfied with the documentation no further work is required.
The one exception to this process is New York State. NY conducts their own inspections of labs across the country and is known to be very thorough. Before a lab can offer LymPro in NY, the lab must submit an extensive package of documents to the New York State Department of Health. They will review the submission and inform the lab if the test is acceptable for NY. They may also conduct a site visit if they feel it is necessary.
In working with NY regulators over the past couple of years I’ve learned that they have a very large backlog and can take 6 to 12 months to approve a new LDT. However, after initial review of the submission they will often issue a provisional approval in 1 to 2 months. In any case, the only constraint arising from not having NY approval is that the lab may not accept samples from physicians in New York State.
I hope that has answered your question, let me know if you’d like more information.
Best regards,
Paul Jorgensen
Head of Diagnostics Product Development
Amarantus Bioscience
Gerald has asked that I answer your question regarding the timing to launch the LymPro assay under CLIA regs. If we partner with an existing clinical laboratory to implement and offer LymPro as a laboratory developed test (LDT), there is no formal application required. The test must be validated in the partner clinical lab and then the lab sends an updated test menu document to the appropriate regulatory body (state or federal, depending on the state in which the lab is located). The test menu would indicate that the lab is now offering the LymPro test. Once that is done the lab may offer LymPro.
The lab will need to have a complete development and validation package on file, as the CLIA inspector will usually ask to review it at the next scheduled inspection. If the inspector is satisfied with the documentation no further work is required.
The one exception to this process is New York State. NY conducts their own inspections of labs across the country and is known to be very thorough. Before a lab can offer LymPro in NY, the lab must submit an extensive package of documents to the New York State Department of Health. They will review the submission and inform the lab if the test is acceptable for NY. They may also conduct a site visit if they feel it is necessary.
In working with NY regulators over the past couple of years I’ve learned that they have a very large backlog and can take 6 to 12 months to approve a new LDT. However, after initial review of the submission they will often issue a provisional approval in 1 to 2 months. In any case, the only constraint arising from not having NY approval is that the lab may not accept samples from physicians in New York State.
I hope that has answered your question, let me know if you’d like more information.
Best regards,
Paul Jorgensen
Head of Diagnostics Product Development
Amarantus Bioscience
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