New York Client Information

New York State Public Health Law and Regulations require samples that are collected from patients within New York State be tested by a clinical laboratory that holds proper New York licensing. Due to the rarity of many genetic conditions, laboratories may not hold proper licensing for all testing options available. However, there can be justification for requesting laboratory testing from a facility that does not hold the specific disease testing permits.

 

In these instances, a Non- Permitted Laboratory Test Request can be submitted to the New York State Health Department for approval. Approval must be granted prior to submitting and testing a sample collected in New York to the non- permitted laboratory. Approval or rejection will be sent in writing to the submitting physician for each request submitted to the department. If the request is rejected, the reason for rejection will be included in the response.

NY State Approval Status - Lantern Project

Test Code Test Name NYS Approved?
B0007 Alpha-Galactosidase A Enzyme (Fabry) Yes
D5033 GLA Gene Sequencing No
B0010 Glucocerebrosidase Enzyme (Gaucher) Yes
D5032 GBA Gene Sequencing No
SAN001 Sanofi MPS Enzyme Panel

(MPS I, MPS II, MPS IIIB, MPS IVA,

MPS IVB, MPS VI, MPS VII)

Only MPS I is approved
B0013 Alpha-L-Iduronidase Enzyme (Hurler) Yes
D5041 IDUA Gene Sequencing No
B0017 Acid Sphingomyelinase Enzyme (Niemann Pick) Yes
D5057 SMPD1 Gene Sequencing No
B0019 Acid Alpha-Glucosidase Enzyme (Pompe) Yes
D5025 GAA Gene Sequencing No
SAN003 GAA Expedited Gene Sequencing No
SAN004 Gaucher Lyso-GL1 (GB1) No
SAN005 Fabry Lyso-GL3 (GB3) Yes
SAN002 LGMD NGS Panel (105 genes) No

 

For Non-Approved Tests

For patients residing in New York State, the following form will need to be completed, submitted and approved by New York State Department of Health prior to submitting a specimen for testing. Once approved, you may submit the patient specimen, test requisition form, and New York approval letter to initiate testing

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