DIAGNOSTIC & TESTING OLIGONUCLEOTIDES
Custom oligos
for market entry
With IP-free oligonucleotides available across Research, Track™, pre-Diagnostic (pre-Dx), and Diagnostic (Dx) grades, we help diagnostic and testing innovators secure traceability, scalability, oligo supply continuity, and regulatory readiness — building confidence at every stage. Whether you are developing your first prototype or preparing for market launch of your kit.
The right oligo grade for your
diagnostic or testing assay
Eurogentec offers a full continuum of oligo grades, from Research to Track™, pre-Diagnostic (Dx), and Diagnostic (Dx).
For diagnostic and testing kit developers, Track™ grade is the ideal starting point: it offers
enhanced traceability, a Certificate of Analysis (CoA), and project manager support — balancing
speed, quality, and control.
When stronger regulatory alignment is needed, you can easily move to ISO 13485–manufactured
pre-Dx or Dx grades, which include batch records and detailed documentation.
Track™ oligonucleotides
With Track™ oligos, traceability is embedded from the very first step. Each batch is delivered with a Certificate of Analysis (CoA) and control analysis documents, ensuring full quality transparency.
Throughout production, your project benefits from personalized follow-up by a dedicated Project Manager, giving you real-time visibility into your oligo’s journey — from synthesis to final delivery.
Pre-Diagnostic oligonucleotides
Pre-Diagnostic (pre-Dx) grade oligonucleotides are manufactured in clean rooms, under an ISO 13485 certified process and come with a dedicated project manager for continuous follow-up from synthesis to delivery. This grade includes triple quantification, validated QC tests, documented traceability, partial batch records, and a signed Certificate of Analysis (CoA) — ideal for beta testing, stability studies, and preparing your CE-IVD regulatory file.
Think ahead with IP-Free
oligo solutions
While IP considerations may appear non-essential in early development, choosing IP-free solutions today can simplify regulatory submissions, avoid hidden fees, and offer greater commercial freedom when you're ready to bring your kit to market.
From small to large scales
Whether you're starting with a small request or scaling up for commercial production, Eurogentec provides the infrastructure and flexibility to follow your growth. We ensure consistent quality, reliable supply, and seamless scale-up — so you can expand your assay with complete confidence.
Reliable supply without risk
From pilot to scale-up, our high-capacity oligo manufacturing together with ISO 7 and ISO 8 classified cleanrooms ensure reliable continuity in oligo supply. We support secure, consistent delivery for diagnostic and testing companies facing demanding timelines and strict regulatory requirements.
Multipurpose oligonucleotides
We manufacture high-quality oligonucleotides for a wide range of applications —from human diagnostics and veterinary testing to food and feed safety, agricultural screening, environmental monitoring, and biopharmaceutical quality controls.
How to accelerate your
market readiness?
Bringing a diagnostic or testing kit to market demands the right strategy from day one.
With design support, regulatory guidance, IP-free oligonucleotides, and a continuum of grades
with increasing documentation and control, we help you speed up development while securing
long-term success.
Our reliable oligo supply ensures continuity from prototype to production, while early QC planning
helps streamline validations and anticipate regulatory requirements — accelerating your path
to market with confidence.
Get your oligo designs right from the start
Get expert advice to optimize your oligos from the first sequence and avoid costly redesigns later.
Boost assay performance with expert design advice
Choosing the right sequences, modifications, and formats early can save critical time later. Our experts support you with oligo design advice tailored to your target assay — whether for qPCR, dPCR, multiplexing, or other workflows. Optimize sensitivity, stability, and compatibility with your platform to avoid costly redesigns and speed up your project.
Navigate regulatory expectations with ease
Stay aligned with regulatory expectations through personalized project management and evolving documentation support.
Project management to guide your oligos to compliance
From your Track™ to pre-Dx and Dx order, our dedicated project managers provide personalized follow-up, helping you align oligo documentation with your intended use. From Certificates of Analysis (CoA) to batch records under ISO 13485, we support your journey through clinical validation, CE-IVD readiness, or FDA submissions — with full visibility at every step.
Faster to market
Avoid hidden cost
Using IP-free dyes and quenchers (e.g. ATTO/BHQ®) eliminates the risk of unexpected licensing fees or royalty payments.
By selecting these components early, you gain full budget transparency and reduce total cost of ownership for your assay — especially important as you move toward commercialization.
Gain commercial freedom
IP-free oligos give you full freedom to operate and scale globally without legal restrictions.
You avoid entanglements with third-party patents, allowing unrestricted use of your assay across geographies and applications — from RUO kits to fully regulated Dx products.
Simplify regulatory submissions
With IP-free reagents, your regulatory file is clearer, more transparent, and easier to review.
No need to provide licensing documentation or legal disclaimers — reducing reviewer questions and accelerating dossier acceptance by notified bodies (e.g. LNE-GMed) or agencies like the FDA.
Select the grade that grows with you
Select the right oligo grade for each project stage — and move smoothly from early validation to market launch.
From Track™ to (pre-) Dx — increasing control, traceability, and compliance
We offer a seamless continuum of oligo grades to match your project stage: from early verification, to beta-test kit production, regulatory submission and commercialization. From ISO 9001- (Research and Track™ ) to ISO 13485-certified processes (pre-Dx and Dx), each grade increases quality controls, documentation, and regulatory readiness — so your oligos scale with your assay development needs.
Count on continuous oligo supply for diagnostic and testing needs
Secure your oligo supply from prototype to commercialization with robust production and global delivery capabilities.
Secure production and global delivery, from prototype to scale
Our large scale facilities, ISO-classified cleanrooms and robust logistics network ensure uninterrupted oligo supply — even as you scale toward commercialization. Trust our proven infrastructure to deliver consistent quality, rapid turnaround, and secure supply continuity for your diagnostic and testing programs.
Validate early, succeed faster
Accelerate your validation timeline with early, tailored QC options supporting regulatory and internal compliance needs.
Build quality and compliance from the start
Early validation of QC methods accelerates your regulatory path and reduces risk later. We support you with customized QC options, from CoAs and traceability documents for Track™ oligos to batch records for pre-Dx and Dx grades — empowering you to build robust, audit-ready diagnostic assays right from development.
