bridgenomics intro & summary of services_jan2017
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www.BRIDGenomics.com
Bridging Gaps in Genomics
Professional Services for Advanced Molecular Testing
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Maximize Your Return on Investment
BRIDGenomics helps clinical organizations develop and commercialize genomic testing and maximize ROI.
Our highly experienced team can reduce your time to assay commercialization by 75% and help you quickly grow revenue.
We’ve done this before and we can do it for you.
Quest Diagnostics
LabPMM Invivoscribe
Cancer Genetics Inc
BioGx
Geneuity
MPLN
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Assay Commercialization
Typical NGS Assay Commercialization Timeline: 9 -18 monthsTypical NGS Assay Commercialization Cost: $500k - $750k
These estimates exclude the cost of equipment
We routinely commercialize NGS-based LDTs in less than 3 months
BRIDGenomics average timeline includes: build out and staffing of lab space, as well as commercialization of testing including state inspection/accreditation in under 90 days.
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Experience Empowers
Our Team’s Selected Publications
This is why we routinely commercialize NGS-based LDTs in less than 3 months
Products Developed and Commercialized Projects supporting multiple sectors
Development and Validation of a Next-Generation Sequencing Assay for BRCA1 and BRCA2 Variants for the Clinical Laboratory. 2015. PLoS ONE 10(8): e0136419. doi:10.1371/journal.pone.0136419
A Genotypic Test for HIV-1 Tropism Combining Sanger Sequencing with Ultradeep Sequencing Predicts Virologic Response in Treatment-Experienced Patients. 2012. PLoS ONE 7(9): e46334. doi:10.1371/journal.pone.0046334
CLSI. Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline – Second Edition. CLSI document MM09-A2. Wayne, PA. Clinical and Laboratory Standards Institute; 2014.
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Depend on our Deep Domain Knowledge
More than 25 years of experience ▪ System, Product, and Assay development and validation▪ High-Complexity Molecular Testing▪ Emerging Technology Market Assessment▪ Implementation of New Technologies ▪ PI on Clinical Studies for Pharma▪ Invited Speaker▪ Significant Patent Portfolio
More than 15 years of global industry experience in molecular testing and NGS▪ System, Product, and Assay Launch▪ Wet bench and Bioinformatic Experienced▪ SEAM Management Certified▪ VOC, KOL and Market Development ▪ Focus Groups/Advisory Board Leader▪ Significant Biomarker and Content Expertise
More than 15 years of clinical diagnostics experience ▪ Assay development, validation, & commercialization▪ High-Complexity Molecular Testing▪ Emerging Technology Market Assessment▪ Implementation of New Technologies in Clinical Diagnostics▪ Clinical Trials for Pharma and Device Manufacturers▪ Genomics program development and pipeline strategies▪ Strategic development and M & A’s
Jamie Platt, PhD, MB(ASCP)CEO/Founder
Shawn Clairmont, MBAChief Operating Officer
Martin Siaw, PhD, MB(ASCP)VP of Science & Innovation
Invited Speakers at the Liquid Biopsy Summit,NextGen Dx Summit, Molecular Medicine TriConference….
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Consulting & Partnering Services
Market Strategy and Development
Portfolio Pipeline
Development
Genomics
Next Generation SequencingTechnology
Emerging Technology
Development
LDT Development Process
Locum Tenens Staffing and Recruiting
Focus Group &
Advisory Board
Informatics
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Processes Pay Off
The Assay Commercialization Process
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Examples of Completed Projects
Global Business Development
Build out (de novo)Transition (low- to high-complexity)
Assay Pipeline Strategy DevelopmentValidation Guidance
NGS Technical ExpertiseWorkflow and Automation
Customization
RegulatoryCAP accreditationCLIA certification
NYS CLEPISO 15189ISO 13485
California DFSCOLA
Pharma + Service ProviderDevice Co. + Technology Co.
Lab + Tools ProviderService Provider + Software Co.
Lab + Lab
Strategic MarketingMarket AssessmentContent Marketing
Focus GroupsAdvisory Boards
White Papers
LaboratorySales and Marketing