New York State Department of Health Issues Clinical Laboratory Permit to Empire Genomics2013-11-12 16:52:36
Molecular diagnostics company launches with full-service CLIA LDT menu.
Date: November 12, 2013
Buffalo, New York - Empire Genomics, LLC (www.empiregenomics.com), an emerging molecular diagnostics company in the field of personalized medicine, announced today that its clinical laboratory facility has met the rigorous standards and obtained approval by the New York State Department of Health, and is now fully licensed (#PFI 8680) in Cytogenetics-Cancer. Simultaneously, Empire Genomics’ lab received Clinical Laboratory Improvements Amendments (CLIA) certification of registration (#33D2043745) from the Centers for Medicare and Medicaid Services (CMS).
Empire Genomics’ new clinical capabilities allow it to work closer with its’ biotech clients to launch Laboratory Developed Test (LDT) companion diagnostics. With the recent announcement of two biomarkers identified in myeloma and prostate cancers, they are slated to offer these biomarkers as CLIA LDT assays in 2014. This is further validation of the high quality standards Empire continues to meet in the delivery of its testing services.
"This is yet another important asset to our business and one that we are extremely proud to have obtained. It is a testament to the highly skilled and dedicated staff that we have at the Company which permits our expansion of complete genomic testing services to our clients," says Anthony Johnson, Empire Genomics President and CEO.
Dr. Theresa Brown, Clinical Lab Director at Empire Genomics, expressed “We are thrilled to have received our New York State laboratory permit so we can begin providing our high quality of testing on clinical samples.”
Empire Genomics will continually seek to add new tests and technologies to its menu as it deems necessary and appropriate to deliver comprehensive personalized medicine services to its customers.