CORE CAPABILITIES

TRANSLATE SCIENTIFIC DISCOVERIES TO COMMERCIAL PRODUCTS

Our experienced scientists have developed and launched over 100 genetic diagnostic assays covering various fields in medicine—Neurology, Endocrinology, Nephrology and Bacteriology. We scan scientific literature, assess intellectual property, evaluate technology and clinical evidence to select the right diagnostic product of clinical value, carry out technology transfer and facilitate translation of scientific discoveries to clinically useful commercial products.

DEVELOP ASSAYS, VALIDATE and LAUNCH PRODUCTS

Umagen LLC will assist you with selection of the most appropriate technology platform, development/optimization of the assay, validations planning, data compilation from validation studies and generation of validation reports for regulatory approvals—CLIA, CAP and NY State DOH. Standard operating protocols and all necessary documents/programs required from compliance standpoint will be implemented for product launch. Technology expertise includes Next Generation sequencing, Array CGH, Multiplex PCR, Real time PCR, Fragment analysis genotyping, MLPA, Southerns, Pulse Field, CRE and ESBL Culture Screen, bacterial ID and susceptibility testing, ELISA and other standard biological techniques.

SET-UP REGULATORY/COMPLIANCE PROGRAMS AND SECURE INDIVIDUAL PRODUCT APPROVALS

Umagen LLC has extensive experience setting up Quality management programs for CLIA, CAP and NY State regulatory approvals and inspections. We have provided services to several clients from ground zero including new laboratory set up, assessment of their current setup with gap analysis, development/implementation of Quality management programs, inspection preparedness, preparing responses post inspection and securing final accreditations/certifications. Individual product package preparation for NY State submissions, responses to critique from molecular/cytogenetic experts and securing final approvals for marketing in the State of NY is a core expertise of Umagen LLC.

DEVELOP VARIANT ANALYSIS PIPELINE, INTERPRETATION AND REPORTING

Advances in Next Generation sequencing technologies and adoption of NGS has become common place as a diagnostic tool in reference laboratories, pharmaceuticals, hospitals and Universities. This has led to an overflow of genetic data raising an acute need for deep analysis of genetic variants pathogenicity interpretation. Our scientists are endowed with subject matter expertise in this area to assist you with variant data analysis, interpretation and development of reports conforming to ACMG guidelines.

MANAGEMENT OF COMPANION DIAGNOSTICS (CDX) PROGRAMS FOR DRUG DEVELOPMENT AND CLINICAL TRIALS

Umagen LLC can provide management and oversight to Companion Diagnostics (CDx) programs contracted to Clinical Laboratories/Contract Research Organizations (CROs) by leading Pharmaceuticals. These services include: (1) Management of the transfer of diagnostics assays developed internally at leading Pharmaceuticals to external CROs or Diagnostics companies, (2) Coordinating operational aspects of CDx implementation in clinical trials (all phases), (3) Managing and providing guidance to both internal and external groups, i.e. developing lab manuals, Good laboratory practices (GLP), Good Clinical practices (GCP, GCLP, CAP and CLIA ), Standard Operating procedures (SOPs), periodic audits etc. and (4) Providing Operational support to CDx programs, Diagnostics Group members and members of other Pharma groups collaborating on CDx development and delivery.