Performance Evaluation for In Vitro Diagnostics
Do you want to develop an in vitro diagnostic and bring it to market? To do so, your product must meet certain performance requirements. In Europe, for example, performance is evaluated in accordance with the European In Vitro Diagnostics Regulation 2017/746 (IVDR), which covers three areas:
Scientific validity means that an analyte is associated with a specific clinical condition or physiological state (IVDR, Article 2 (38)).
Analytical performance refers to the ability that a particular analyte can be correctly detected or measured (IVDR, Article 2 (40)).
Clinical performance describes the ability to provide results that correlate with a specific clinical condition or physiological or pathological process or state (IVDR, Article 2 (41)).
In addition, according to the IVDR, you must evaluate performance both before and after market launch:
Before market introduction, manufacturers must identify all available data on the product, its intended use and safety, and fill data gaps in order to assess performance. Outstanding issues require the conduct of appropriate studies (IVDR, Annex XIII, Part A, 1.2).
After a product has been launched, manufacturers should proactively collect and evaluate performance and scientific data resulting from the product's use to ensure safety, performance, and scientific validity throughout the product's lifetime and to identify any risks (IVDR, Annex XIII, Part B, 4).
What to expect from BIOMEX
As a renowned regulatory expert and contract research organization, we provide professional support at every step of the performance evaluation process and also offer a variety of studies that are important for evaluation.
For example, with regard to analytical performance under IVDR, we offer testing of all relevant Annex I parameters such as analytical sensitivity, analytical specificity, trueness, precision, and accuracy.
Also, in the area of clinical performance, we provide all studies testing Annex I parameters, such as diagnostic sensitivity, diagnostic specificity, positive and negative predictive value, likelihood ratio, and expected values in normal and affected populations.
Clinical performance studies
A clinical performance study focuses on the patient. Depending on your product, demonstrating clinical performance may require different types of studies. BIOMEX offers studies for several scenarios, including:
Clinical performance studies are to establish or confirm aspects of device safety and performance which cannot be determined by literature and/or previous experience gained by routine diagnostic testing.
Products designed to be performed by a healthcare professional on a patient outside of a laboratory environment are products for near-patient or point-of-care testing.
Products that are to be used by laypersons for self-testing must comply with certain specifications, e.g., in terms of safety, applicability, and significance of their results.
Why to trust BIOMEX
We have successfully conducted hundreds of studies, not only according to European specifications, but also, for example, according to Chinese (NMPA) and Australian (TGA) regulations or according to the specifications of the World Health Organization (WHO).
The validated assays include numerous indications and analytes, such as HIV, HPV, HCV, HBV, HAV, SARS-CoV-2, syphilis, hemoglobin, bilirubin, urobilinogen, ketone, protein, nitrite, glucose, pH, leukocytes, and ascorbic acid.
For SARS-CoV-2 rapid tests alone, we are the provider that has validated the largest number of assays according to the European IVD Regulation.
How we conduct your study – together with you
We know that every customer project is different. To convert challenges into success stories, here is how we work:
In an online meeting – or together on site at our headquarters in Heidelberg – we will discuss your project with you.
Afterwards, BIOMEX’s experts will check the feasibility of your project, the capacity of staff and infrastructure, and the availability of all samples.
You will receive an individual offer for the study, including duration and costs.
Ready to go
If you agree with the offer, you are ready to go: We will create a study plan for you and coordinate it with you.
Collection and sample preparation
Depending on study requirements, collection and sample preparation will start. If necessary, we search our databases for suitable donors and plan a prospective sample collection.
Your study begins
Laboratory staff are trained and required reagents prepared – and after an internal kick-off meeting, we can get started: Your study begins.
Sampling & testing
The study is underway: Sampling is in progress. Your device is being tested, including reference testing, which involves comprehensive quality control.
We manage and analyze the data so that you receive a preliminary study report for revision.
Your study report
Upon completion of the study, you will receive the final study report.
Would you like to get started? Please contact us.
Your Experts for Diagnostic Studies
You want to bring your assay to market as quickly as possible? We can help you with this – with our years of experience in diagnostic assay validation, broad regulatory expertise, large in-house biospecimens inventory, and our own donations centers.