FAQ Companion Diagnostics

A companion diagnostics (CDx) test is defined as a medical device that provides information that is essential for the safe and effective use of a corresponding therapy. More specifically, a companion diagnostics is a diagnostic test that is clinically proven to accurately and reliably identify patients that are most likely to benefit from the associated therapy or at increased risk for serious adverse reactions from the associated therapy.

• Pharmacological clinical trials with patient selection as part of the inclusion/exclusion criteria and may need an investigational in vitro diagnostic (IVD) medical device for medical management decisions. A CDx can screen specific biomarkers and identify patients that are likely to respond to the therapy or patients that are at increased risk for adverse events.
• Including a CDx in your precision medicine strategy can increases the likelihood of a positive response and better clinical outcomes, as the CDx can match the right patients with the right treatment. The use of a CDx to pre-screen and select patients for clinical trials can lead to more efficient trials as the trial population is more targeted, possibly reducing the cost and shortening timelines.

• FDA: In order to obtain FDA approval for a companion diagnostic, the CDx needs to show robust analytical validity (accurately and reliably detect the biomarker of interest), clinical validity (predict the patient’s response to treatment) and clinical utility (appropriately inform patient management and improve patient outcomes). Additionally the CDx needs to comply to a high standard of manufacturing. Including the final CDx assay in a phase 3 pharmacological clinical trial maximizes the likelihood of drug/CDx co-approval, as both can be clinically validated by the results of the pharmacological trial. Understanding the CDx process to receive FDA or IVDR approval is crucial. Subsequently an application for authorization is submitted to FDA, often either a Premarket Notification 510(k) or a Premarket Approval (PMA). FDA will then assess the application including the analytical and clinical performance, and if applicable issue an approval of the Companion Diagnostic device.
• IVDR: In order to obtain IVDR approval for a companion diagnostic, a multi-step process needs to be followed. The process starts with the development of the CDx and the analytical and clinical performance evaluation. A comprehensive technical dossier is prepared and submitted to a Notified Body. Following a conformity assessment by a Notified Body and a scientific consultation with a competent authority (EMA), a  final CE marking can be issued.
• GenDx was the first company in the field of transplant diagnostics complying to IVD Regulation (IVDR) and obtain IVDR certification for diagnostic use of GenDx’s HLA product portfolio. With GenDx’s ISO13485 compliant Quality Management System and our regulatory proficiency, we can effectively and efficiently support your CDx development.

• GenDx can facilitate the development of your requested assay from prototype concept to registered Companion Diagnostic IVD. Our team of Research & Development and Operational experts will support the development of a robust IVD and our Regulatory experts will facilitate an effective performance study application process for authorization of a clinical study to validate the clinical validity of the device.
• If applicable, your CDx can leverage technical validation of our currently CE marked devices for transplantation purposes, shortening development timelines. In alignment with your requirements, we will develop and design the clinical trial assay for use in interventional clinical trials or retrospective bridging studies. The IVD will be developed and validated, compliant with EU (IVDR) and/or US (FDA) regulations.

• GenDx can develop a CDx from Idea to IVD, for any gene of interest. Development trajectories and timelines differ when starting from a CE marked device (for different intended purposes), from a Research Use Only (RUO) device or from a prototype or concept. The technical validation of the CE marked and RUO solutions may be used for streamlined development.
• GenDx does already have CE marked devices for transplantation purposes targeting HLA-A, -B, -C, -DRB1, -DRB3/4/5, -DQB1, -DQA1, -DPB1 and DPA1. Additionally, GenDx offers RUO solutions for KIR, MICA and MICB gene analysis. Alternatively, we can use our expertise in molecular diagnostic solutions to design and develop your CDx from Idea to IVD. It follows that such a development from Idea to IVD will take longer than starting from a CE marked kit.

Every project is unique and will require a tailor-made project design. Typically, it takes approximately around 15 months from device to clinical trial assay, depending on many factors, including but not limited to clinical indication and assay validation status. If the project starts from a CE marked device with a different intended purpose (e.g. our NGSgo HLA devices), development timelines can often be streamlined and shortened.

As the (companion) diagnostic strategy can affect the pharmacological strategy and impact timelines for clinical trail applications, it is recommended to start as early as possible. GenDx recommends to contact us prior to or when planning Phase 1 trials, as we may be able to support you during this phase too.

• GenDx can support your therapy development in any stage, during the pre-clinical stage with RUO reagents and during the clinical stages, from first in human to the pivotal registrational trial. At the moment, that clinical device studies are required, GenDx can support interventional clinical studies (both prospective and retrospective) and clinical bridging studies.
• As IVD sponsor of the clinical study we facilitate performance study applications to the regulatory authorities and ethical bodies and we ensure clinical monitoring of the clinical testing site, through our strong network of partners.

GenDx always starts with an introductory meeting or discussion to understand your needs and requirements. We will investigate how GenDx can support your project. Do not hesitate to contact us, even if your diagnostic strategy hasn’t fully crystallized, the GenDx CDx team can support your project also by providing our expertise and assist you in shaping your strategy.