Empowering your drug discovery success
Transforming innovative ideas
into healthcare revolutions

GoPath Biopharma is committed to delivering innovative solutions for biopharmaceutical development. With a focus on quality, reliability, and efficiency, we aim to support our clients

in advancing their biopharmaceutical products from concept to commercialization. Our state-of-the-art facilities and experienced team enable us to offer a wide range of services, including central lab services with fully customizable advanced testing strategies, clinical trial design

and regulatory consulting. We are dedicated to driving success in biopharmaceutical research and development through collaboration, expertise, and cutting-edge technologies. Whichever should be your drug development challenge, our team of MD and PhD scientists will guide you towards success.​

Central lab services
Histopathology & Digital Pathology
  • IHC:

    We provide a wide range of IHC-based biomarker testing services from a selection of validated assays,

    to customized assays including antibody selection and validation, to the proper (selection) of control tissues from our large biopsy tissues repository.

    IHC test menu:
Platforms IHC test menu:
Leica Bond Rx & Bond III
Roche Ventana
BenchMark ULTRA​
Agilent Dako
Autostainer 48
intelliPATH
FLX® IHC System​
Varistain Gemini
Digital Pathology
Embedding powerful algorithms into pathologists' skill sets, digital pathology enhances their capabilities and accelerates the delivery of data
to make informed decisions.
Molecular Pathology
  • With our innovative and diverse genomic capabilities combined with our problem-solving skills, GoPath Biopharma team is skilled to deliver a complete set of streamlined testing solutions and new assay design and validation services, using high-throughput technology to serve both emerging biotech and large pharmaceutical companies.

    With the most up-to-date technologies in gene expression, genotyping and next generation sequencing, our scientists will design the optimal assays on cutting-edge platforms, meeting all your requirements for both pre-clinical and clinical studies or nonclinical studies.
Digital PCR
RT-PCR
Sanger sequencing
Next-Generation Sequencing
MRD

Cytogenetics (Karyotyping)

Chromosome analysis, or karyotyping, involves analyzing the number and structure of chromosomes to detect abnormalities. A live cell sample is collected and cultured to promote cell division. The cell cycle is arrested in metaphase, and the isolated chromosomes are placed on a slide and stained. Each chromosome has a unique fingerprint, and they are mapped and examined for changes in number and arrangement. Karyotyping looks for gross structural abnormalities in the DNA and is essential for the proper diagnosis of acute leukemias and myelodysplastic syndromes.
FISH
GoPath offers a wide variety of individual probes and panels to complement the study's workup, as well as custom probes tailored to specific end-goals.
Biocare Oncore Pro

Hematopathology

  • Standard:
    Flow cytometry:
    GoPath Biopharma offers full-service flow cytometry services whether using CLIA-validated test panels or study-specific biomarker assay development, including discovery and validation, whether for clinical studies or precision medicine (targeted therapy).
Platforms:
BD FACSLyric
Beckman Coulter Navios

Companion Diagnostics (CDx)

As an integral part of precision medicine, CDx allows scientific investigators and clinicians during clinical trials to:
  • Prescreen candidates to select those who would most likely benefit from therapy

  • Monitor their response
    to treatment either
    for dosage adjustment
    or discontinuation
  • Achieve drug safety while reducing development time
    and cost

Whether your CDx goal necessitates in-house laboratory developed test or FDA-approved in vitro diagnostic test, our Biopharma team provides full-service assay development to reach your objectives.

  • Biomarker identification

    & development

  • Assay development

    and validation

  • Regulatory guidance: Premarket Approval (PMA) application development and submission

Specimen management & Kit design

Transport, storage and optimal sample handling are critical steps for the preservation of the sample's quality and integrity necessary for cutting-edge technology testings in maximizing data insight.

Biospecimen Management

Our global processing shipment and logistics services include the following:

  • Follow the sample from collection to analysis

  • Custom kit assembly

  • Optimized shipment operations

Our biorepository can store fluid and solid specimens at controlled ambient temperatures, +4°C, -20°C,

and -80°C, and includes numerous security and safety features:

  • Dedicated back-up units

  • Around-the-clock automated temperature monitoring

  • Sample accessioning for all sample types: 5-day TAT approx

Clinical trial design and regulatory consulting​
GoPath has partnered with GenReq, a Regulatory Affairs, Clinical Research, Medical Affairs and Safety consulting firm with extensive experience in order to provide our clients with an integrated business solutions to license, import, distribute, manufacture and/or market healthcare products globally including US, Canada, China and EU.

From testing to approval, we ensure your regulatory pathway will be successful.

OUR RANGE OF SERVICES COVERS:
  • In-Vitro Diagnostics (IVD) devices
    Molecular Diagnostics, Companion Dx, COVID-19 PCR, Antibody or Antigen Test, Digital Scanners, and Lab Validation​
  • Medical Devices
    510(k)s, PMA, Q-Sub, EUA​
  • Drug
    FDA meetings, Pre-IND, EOP2, Accelerated Programs, IND preparation and review (CMC, Nonclinical, Clinical), NDA preparation,DMF preparation, Safety Monitoring, Communication with Agency (Responses to Warning Letters and Inquires)​
  • Clinical Trials
    Protocol design consulting and writing for laboratory logistics and science​
Meet Our Team
Fei Chu, M.D., Ph.D.
Director - Biopharma and Medical Affairs​

Hao Luo, Ph.D.

Deputy Director - Biopharma Initiatives​

David Wilson, M.D.

Director - Hematopathology​

John Wang, Ph.D.

Director - Molecular Diagnostics and Development​

Dan Huang, M.D.

Staff Scientist - Anatomic Pathology and Histology​

Ingrid Safina, Ph.D.

Staff Scientist - Scientific Affairs and R&D​

Andre Iovane, Ph.D., M.Sc.

Staff Scientist – Scientific Project Manager and Regulatory Affairs​

Gary Cai, M.Sc., RAC, GM

Director - Regulatory Affairs​

Sarah Bacus, Ph.D.

Scientific Advisor​
Quality Management
  • A Quality Management System (QMS) is the cornerstone of a contract research laboratory's ability to consistently provide services that meet customer and regulatory requirements. GoPath has set up a highly structured system of processes aimed at ensuring the quality and integrity of the laboratory's output, encompassing all aspects of the laboratory's operations, from sample receipt and testing to data analysis, reporting, and archiving. We strive to achieve customer satisfaction and continuous improvement in all aspects of the laboratory's performance. ​


    For that, GoPath relies on a broad Quality control (QC) and Quality assurance (QA) program, supported by a robust document control system, regular competency assessments and trainings for the employees.

    GoPath is certified to comply with the Clinical Laboratory Improvement Amendments (CLIA) in Illinois, Arizona and New York State, accredited by the College of American Pathologists (CAP) and compliant to WHO's Good Clinical Laboratory Practice (GCLP) standards.​

Our Successful Cases
1

Molecular biomarkers validation with qPCR assay and clinical testing of various biological specimens for Phase 1b clinical trial. ​

2

First in class drug PD assay, with a complex multi-platform scientific strategy design and implementation, including ctDNA testing; regulatory services for Phase 1 & 2.​

3

Cancer progression monitoring and therapy efficacy assessment through NGS analytical & clinical validation for precision medicine for Phase I.​

4

Biomarkers discovery for clinical trial design with novel proprietary IHC assay development and validation for Phase ½.​

Biopharma and Medical Device Partners

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