What is A Companion Diagnostic?
A companion diagnostic (CDx) is a medical device, often an in vitro device, which provides essential information for the safe and effective use of a corresponding drug or biological product. The test helps a healthcare professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.
In 2014, FDA issued “Guidance for Industry: In Vitro Companion Diagnostic Devices,” to help companies identify the need for CDx at an earlier stage in the drug development process and to plan for co-development of the drug and CDx test. The ultimate goal of the guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients with serious and life-threatening diseases.
State-of-the-art Molecular Detection Platform
Novogene employs cutting-edge technology to provide leading-edge analysis and solutions. We own and operate a wide array of state-of-the-art Illumina and PacBio systems, including Illumina NovaSeq 6000, HiSeq 4000, HiSeq 2500, PacBio Sequel, Oxford Nanopore PromethION, and Thermo Fisher Ion proton and QuantStudio 3D PCR platform. This range of systems enables us to select the most appropriate technology and system to meet our customers’ needs and ensure the best results.
Global Testing Center
Novogene has academic sequencing labs in the US (at University of California, Davis campus), China, Singapore, and the UK (Cambridge) as well as a CAP-accredited medical lab and a CLIA-accredited medical lab in Tianjin and Sacramento respectively. Our globally situated labs provide fully integrated cutting-edge sequencing solutions to preclinical, translational, clinical and diagnostic R&D needs of our clients from across the world.
Leading Data Center
Novogene has an advanced high-performance computing platform and data center with a computing capacity of up to 1727 T, a total RAM of 410 TB, and a total storage of 62 PB. Our supercomputing capability allows us to analyze 280,000 whole human genomes per year. To date, we have obtained 157 software copyrights and 27 patents. Our unmatched bioinformatics expertise strongly support the need for our customers.
Successful CDx Registration Experience
NovoFocus? NSCLC CDx Test is an NMPA (formerly CFDA)-approved next-generation sequencing (NGS)-based in vitro companion diagnostic (CDx). The test is currently the only NGS-based in vitro CDx test in China for which the sequencing instrument, the reagent kit, and the data analysis/reporting software have all received Class III clearance from NMPA.
High Quality of GMP Manufacture
Novogene owns a 450 ㎡, 100,000-class GMP manufacture site in Tianjin, equipped with advanced production equipment, which provides reliable production support for in vitro diagnostic products based on NGS and digital PCR technology.
CDx Development Services Provided by Novogene
With scientific excellence, great customer service, and unsurpassed data quality, Novogene is committed to providing our pharma clients with front to end CDx services, including biomarker screening, CDx development & validation & registration, cGMP kit manufacturing, and marketing.
*The services are only available in China
- Develop a CDx of a first-in-class anticancer drug A for an innovative pharmaceutical company.
- Using the NovoPM? solid tumor genomic profiling test to perform the potential predictive biomarker analysis on patient samples collected in phase I clinical trials of drug A.
- Select the most suitable molecular detection platform to develop and verify the RUO (Research Use Only) CDx based on the biomarker analysis results.
- The RUO CDx was used for screening prospective patients in phase II clinical trial of drug A and analyzing the predictive biomarker.
- Once the predictive performance of the RUO CDx was validated, Novogene will manufacture and register the kit, then the RUO CDx will turn into Investigational Use Only (IUO) CDx. We will verify the performance of IUO CDx in phase III clinical trial of drug A.
- We have found the potential predictive biomarker for drug A successfully.
- We are developing the Research Use Only (RUO) CDx of drug A, which will be used in phase II clinical trials.