Bio-Rad secures IVDR certification for molecular quality controls portfolio
Bio-Rad Laboratories has achieved a significant regulatory milestone with EU Quality Management Systems certification under the In Vitro Diagnostic Regulation (IVDR), enabling CE marking for 40 infectious disease molecular quality control products from their Exact Diagnostics brand.
Regulatory transition marks shift in European diagnostic standards
The certification represents a major step in Bio-Rad’s compliance with the more stringent IVDR framework (Regulation (EU) 2017/746), which replaces the previous IVD Directive 98/79/EC. Under the new regulations, manufacturers can no longer self-certify most quality control products but must instead undergo assessment by an accredited notified body – a substantial elevation in regulatory requirements for in vitro diagnostic products in the European market.
This regulatory shift aims to enhance patient safety and product performance across the EU diagnostic landscape, with Bio-Rad positioning itself at the forefront of this transition.
Technical design supports laboratory compliance requirements
The certified Exact Diagnostics molecular controls feature whole organisms formulated in clinically relevant matrices, designed to simulate actual patient specimens. This approach ensures the controls face identical workflow challenges and processes as patient samples during routine diagnostic testing.
Such design characteristics support laboratories in meeting their compliance requirements under the revised ISO 15189:2022 guidelines for medical laboratories, providing a comprehensive quality assurance solution for molecular diagnostic workflows.
Cost-efficiency and sustainability considerations
The Bio-Rad controls offer multiple-use functionality, potentially reducing both operational costs and laboratory waste – an important consideration for clinical diagnostic laboratories managing increasing test volumes and environmental responsibilities. Each positive control can be paired with a corresponding negative control from the Exact Diagnostics portfolio, streamlining validation procedures.
Market availability timeline
According to the company, the CT/NG Positive Run Control (CTNGPOS) and STI Negative Run Control (NEGSTI) will be the first products to receive CE marking under the IVDR, with market release anticipated by the end of Q1 2025. The remaining 38 products in the certified portfolio will follow in subsequent release phases.
Product portfolio encompasses critical infectious disease targets
The IVDR-certified controls cover a comprehensive range of infectious disease targets critical for clinical diagnostics, including:
- Viral pathogens: Adenovirus, BK virus, Cytomegalovirus, Epstein-Barr virus, HHV-6, HSV-1, HSV-2, JC virus, Parvovirus B19, Varicella-zoster virus, and Zika virus
- Bacterial pathogens: Chlamydia trachomatis, Neisseria gonorrhoeae, Anaplasma, Babesia, Bartonella, Borrelia, and Ehrlichia
- Respiratory pathogens: SARS-CoV-2, Influenza, and RSV
- Other targets: Enterovirus and Human papillomavirus genotypes
This diverse portfolio demonstrates Bio-Rad’s comprehensive approach to supporting molecular diagnostic testing across multiple infectious disease categories, providing quality control solutions for laboratories performing these critical diagnostic tests.
The products that can now be CE Marked under IVDR include:
- Adenovirus High and Low Run Controls (ADVH102 and ADVL101)
- Anaplasma Run Control (ANARC)
- Babesia Run Control (BABRC)
- Bartonella Run Control (BRTRC)
- BKV High and Low Run Controls (BKVH102 and BKVL101)
- Borrelia Run Control (BORRC)
- CMV High and Low Run Controls (CMVH102 and CMVL101)
- CT/NG Positive Run Control and STI Negative Control (CTNGPOS and NEGSTI)
- EBV High and Low Run Controls (EBVH102 and EBVL101)
- Ehrlichia Run Control (ERLRC)
- Enterovirus Run Control (EVRC)
- HHV-6 High and Low Run Controls (HV6H102 and HV6L101)
- HPV Genotype 16, 18, 68 Controls and HPV Negative (HPV16C, HPV18C, HPV68C and HPVNEG)
- HSV-1 High and Low Run Controls (HSV1H102 and HSV1L101)
- HSV-2 High and Low Run Controls (HSV2H102 and HSV2L101)
- JCV High and Low Run Controls (JCVH102 and JCVL101)
- Parvovirus B19 High and Low Run Controls (B19H102 and B19L101)
- Respiratory (RP) Positive and Negative Controls (RPPOS and RPNEG)
- SARS-CoV-2 Positive and Negative Run Controls (COV019CE and COV000CE)
- SARS-CoV-2, Flu, RSV Positive and Negative Run Controls (COVFLU and COVFLUNEG)
- VZV High and Low Run Controls (VZVH102 and VZVL101)
- ZKV High and Low Run Controls (ZKVH102 and ZKVL101)
