Today, Invivoscribe announced that its Shanghai lab in China has received CAP accreditation.

The College of American Pathologists (CAP) is a professional organization that accredits clinical laboratories across the world. The CAP accreditation process is designed to ensure that laboratories meet or exceed the highest quality management system standards specific to patient testing. The process includes a thorough inspection of the laboratory’s facilities, equipment, personnel, and processes, as well as an evaluation of the laboratory’s performance and proficiency testing results. Laboratories that pass the accreditation process are awarded a CAP accreditation certificate. Accreditation by the CAP is recognized and accepted by the US federal government and most state governments as evidence of a laboratory’s quality and competency. Labs in China use this standard since a similar China specific standard does not yet exist and the ISO15189 standard lacks the assay-specific details included in the CAP requirements.

Pharmaceutical companies conducting clinical research have a number of requirements that must be met in order to successfully bring a new drug or treatment to market. These include:

1. Regulatory compliance: Clinical research must comply with local, national, and international regulations, such as Good Clinical Practice (GCP) guidelines. Companies need to have a deep understanding of these regulations and have processes in place to ensure compliance. Clinical research involves working with human subjects, and pharmaceutical companies need to ensure that the privacy, rights and welfare of the participants are protected. This includes obtaining informed consent and ensuring that the trial is conducted in an ethical manner.
2. Patient recruitment: Pharmaceutical companies need to enroll enough patients for their clinical trials. This can be challenging, as patients may be hesitant to participate in research or may not meet the inclusion criteria for the trial.
3. Qualified investigators: Clinical research requires the participation of qualified investigators who can conduct the trials according to the protocols. These investigators and their sites must have the necessary qualifications and experience.
4. Data management: Clinical research generates a large amount of data, which needs to be collected, stored, and analyzed. Pharmaceutical companies need to have robust data management systems in place to ensure that the data is accurate, complete, and accessible.
5. Quality management system: Clinical research is a complex process, and it is essential that the drug company and its trial partners have accredited quality management systems in place to ensure that the research is conducted in a consistent and controlled manner.

Invivoscribe has expertise in all of the above.

“With the addition of our CAP accreditation in China, now the entire Invivoscribe testing lab network serving the US, the EU, Japan, and China have certifications from the necessary regulatory bodies to support our pharmaceutical partners’ clinical research and development needs.  These labs offer an extensive oncology test menu utilizing the latest diagnostic and measurable residual disease (MRD) assays tailored to effectively identify the biomarker target, as well as the specific needs of our partner. Available assays and technologies include molecular, sequencing, gene panels, and flow cytometry panels,” says Jason Gerhold, Global Director of Regulatory, Quality, and Clinical Affairs.

Companion diagnostic development also requires close collaboration between pharmaceutical companies, diagnostic test manufacturers, and regulatory authorities. From initial clinical research studies through commercialization, Invivoscribe has proven we can move partners through our vertically integrated ecosystem to accelerate companion diagnostic (CDx) development and approvals. The development of a companion diagnostics is a complex process that involves several partners and multiple steps, including: biomarker discovery, development, analytical and clinical validation, regulatory approval, commercialization, and monitoring and maintenance.

1. Discovery: Researchers identify biomarkers that can be used to predict the presence or progression of a disease, or to predict which patients are most likely to respond to a particular treatment.
2. Analytical validation: The biomarker(s) is validated through laboratory and clinical studies to ensure that it is accurate and reliable.
3. Development: The diagnostic test is developed and manufactured, which includes creating reagents and performing laboratory evaluations.
4. Clinical validation: The diagnostic test is then clinically validated through studies in patient populations to ensure that it is accurate and reliable.
5. Regulatory approval: The diagnostic test may need to be approved by regulatory bodies such as the U.S. Food and Drug Administration (FDA), a European Notified Body, the MHLW/PMDA (Japan), the NMPA (China), etc. in parallel with companion drug so that both can be released to market.
6. Commercialization: After approval, the diagnostic test is made available to healthcare providers and patients.
7. Monitoring and maintenance: Once the companion diagnostic is commercialized, the company needs to monitor its performance and make sure it is being used appropriately. This may include gathering data on the test’s performance, and updating the labeling software as necessary.

With 3 CDx assay approvals by multiple regulatory bodies worldwide, and several more in development, this CAP accreditation in China is further evidence that Invivoscribe continues to expand its ability to support regional and global pharma and biopharma partners worldwide.