GTC: Your Premier Partner for Companion Diagnostics in Oncology Drug Development
When embarking on a companion diagnostic (CDx) development project for oncology drug development, selecting the right partner is crucial for success. GTC stands out as a formidable choice, offering a comprehensive value proposition that meets and exceeds industry requirements.
Partnering with GTC for your CDx development project is a strategic decision that brings together scientific expertise, regulatory prowess, innovative assay development, uncompromising quality, and seamless scalability. By choosing GTC, you gain a trusted ally that shares your commitment to precision medicine and the improvement of patient outcomes.
Biomarker Discovery for Precision Oncology:
GTC’s dedication to advancing precision medicine extends to biomarker discovery. Our cutting-edge technologies and robust analytical pipelines enable us to identify novel biomarkers associated with specific cancers. Leveraging the power of genomics and transcriptomics, we unearth valuable insights into tumor biology, enabling the development of targeted therapies and patient stratification strategies.
Explore GTC's CDx capabilities
Expertise and Experience:
GTC has a staff of experts who have been working on NGS since its inception and have developed an impressive portfolio of IP.
GTC’s tests are covered by Medicare, NY-state approved and CE-IVD. We are well prepared to take an assay to the FDA.
Assay Development Capabilities:
As you can see from GTC’s website we are experts in assay development and innovation. Additionally, we are offer sophisticated AI tools that go beyond just a technically great assay, we create best in class analysis tools to identify mutations and more.
Quality Control and Quality Assurance:
GTC has an exceptional record of quality having passed all of our pharma audits with no major findings. We go to great lengths to ensure our assays and lab SOPs are of the highest quality.
Scalability and commercial excellence:
We have a network of co-op laboratories that will immediately be able to sell your CDx and identify patients who would benefit from the corresponding therapeutic.
For a successful CDx collaboration and unparalleled scientific solutions, connect with GTC today. Let us transform your vision into reality and drive the future of personalized oncology care.
1. Unparalleled Expertise and Experience:
At GTC, we take pride in our team of NGS experts who have been pioneers in the field since its inception. With an extensive portfolio of intellectual property (IP), we have demonstrated unmatched expertise in genomics and precision medicine. Our seasoned professionals bring a wealth of experience to every CDx project, ensuring excellence at every stage of development.
2. Regulatory Knowledge and Compliance:
With GTC, you can rest assured that your CDx assays are in capable hands. Our tests are backed by rigorous regulatory approvals, including coverage by Medicare, NY-state approval, and CE-IVD certification. Our comprehensive understanding of regulatory guidelines positions us to seamlessly navigate the complex process of FDA submission, expediting your CDx’s path to market.
3. Cutting-Edge Assay Development Capabilities:
GTC’s reputation for assay development and innovation is well-earned. Our website showcases our expertise in designing technically superior assays, but our capabilities don’t end there. Leveraging sophisticated AI tools, we deliver best-in-class analysis to identify critical mutations and beyond, empowering accurate and personalized treatment decisions for patients.
4. Unwavering Commitment to Quality Control and Assurance:
Maintaining the highest quality standards is a cornerstone of our philosophy at GTC. Our exceptional record of passing all pharma audits without major findings underscores our commitment to excellence. We take meticulous care to ensure that our assays and lab Standard Operating Procedures (SOPs) adhere to stringent quality control measures, providing confidence and reliability in our CDx products.
5. Scalability and Commercial Excellence:
GTC’s vast network of co-op laboratories enables seamless integration of your CDx into the market. Our extensive commercial capabilities ensure swift identification and engagement of patients who stand to benefit from your corresponding therapeutic, maximizing the impact of your oncology drug development.
The Co-Op Network
- GTC has numerous co-op members who can be used as testing sites or trial enrollment sites.
- Assays can be transferred to any lab in the world to help support trial needs in any country.
- Leverage the power of multiple institutions for broader perspectives on testing, therapeutic implementation, data and more…