NuGEN is working with leading molecular diagnostic companies in the development and commercialization of genomic diagnostic and prognostic tests. The enabling characteristics of NuGEN’s sample preparation technologies translate well to clinical settings where samples are often limited, and whole blood and FFPE are widely used sample types.
To support these partners, NuGEN has established rigorous quality standards which include ISO 13485:2003 certification and cGMP licensure by the State of California, making it one of the first reagent companies to meet these exacting qualifications. Some of our partners include:
Helomics™ has licensed the GeneFx™ Colon test from Almac Diagnostics for stage II colon cancer and uses NuGEN’s amplification and labeling technologies for RNA from formalin-fixed paraffin-embedded tissue (FFPE) to prepare patient samples. The GeneFx™ Colon test is for the identification of stage II colon cancer patients who are at high risk of recurrence following surgery and thus may be candidates for adjuvant chemotherapy. Helomics™ plans to have the test commercially available in 2016.
GenomeDx Biosciences employs NuGEN’s amplification and labeling technology for RNA from formalin-fixed paraffin-embedded tissue (FFPE) in a new prostate cancer test. The Decipher® test can predict which patients are likely to benefit from radiation therapy following prostate surgery. GenomeDx Biosciences announced in January 2015 that Decipher® has been approved for Medicare reimbursement.
Veracyte® utilizes NuGEN’s RNA amplification and labeling technology in its Afirma® Thyroid FNA Analysis assay for stratification of indeterminate thyroid tumors. The test greatly reduces unneeded surgical intervention in patients and is reimbursed by Medicare and numerous other health insurers.
NuGEN offers flexible options for OEM or product and technology licensing of its robust and reliable nucleic acid sample preparation solutions. Diagnostic companies can utilize NuGEN technologies in their CLIA services or market their own branded IVD products powered by NuGEN’s innovations.
NuGEN also offers services to diagnostics companies to support the development of new diagnostic products or to solve specific sample preparation problems. NuGEN is ISO 13485 certified and licensed by the state of California for cGMP manufacture of all its products.
Please contact us at firstname.lastname@example.org (888-654-6544) to explore the NuGEN solutions and capabilities that would best serve your company’s diagnostic products or services goals.