In diagnostics, trust is everything. A single unreliable reagent, inconsistent antibody pair, or delayed shipment can derail entire validation pipelines. For diagnostic manufacturers competing in a fast-moving global market, consistency and reproducibility are not just “nice to have”, they are non-negotiable.
At deNOVO Biolabs, we have built our story around one principle: earning trust through science, validation and reliability. Today, our reagents and kits are used by diagnostic manufacturers across the world, helping them scale faster, cut time-to-market, and deliver accurate results to the patients who need them most.
This blog shares how we got here, why global players trust us, and what sets our capabilities apart.
The Global Diagnostics Market
The global in vitro diagnostics (IVD) market was valued at USD 120.6 billion in 2023 and is projected to reach USD 146.3 billion by 2028, growing at a CAGR of 3.9%
But with growth comes complexity:
- Increasing demand for early disease detection
- Stricter regulatory frameworks for diagnostic products
- Rising competition among manufacturers for market share and speed
In such an environment, the difference between success and failure often comes down to the quality of reagents used in assay development and validation.
That’s where deNOVO comes in.
From India to the World:
deNOVO’s Growth Journey
Founded with a mission to deliver high-quality reagents and diagnostic solutions, deNOVO started by serving local diagnostic manufacturers. Over time, our focus on validation, reproducibility and customer trust helped us expand to global markets.
Today, we supply to partners across the globe. Our products have been validated not just in our labs, but in the hands of manufacturers who rely on them for clinical trials, diagnostic kits and research applications.
Why Global Manufacturers trust us?
1. Validated Antibody Pairs
Unvalidated antibody pairs are a hidden cost in diagnostics, leading to false positives, wasted samples, and higher development timelines. At deNOVO, we supply LFA and ELISA validated monoclonal antibody pairs that cut down assay troubleshooting time and improve early disease detection.
Example: Our Dengue NS1 and HBsAg antibody pairs have been validated using clinically positive plasma/serum samples, ensuring reproducibility and reliability in real-world conditions.
2. Super-Sensitive Substrates
Signal clarity matters. Our super-sensitive TMB substrates deliver sharper optical density, lower background noise, and greater assay reproducibility. For diagnostic manufacturers, this translates into:
- Higher sensitivity
- Lower detection limits (as low as 20 pg/mL)
- Fewer repeat assays
3. Recombinant & Native Proteins
Whether it is native CRP protein for inflammation studies or recombinant TNF-alpha for IVD applications, our proteins are:
- Produced in advanced expression systems (E. coli, mammalian)
- High purity and activity validated
- Available in custom production formats
This flexibility allows global diagnostic manufacturers to reduce dependence on inconsistent imports and scale their R&D pipelines with confidence.
4. Custom Development
Every diagnostic company has unique challenges. That is why we also offer custom antibody development, protein engineering and assay reagent production. Our agile team works closely with clients to design solutions tailored to their assay workflows.
5. Global-Standard Quality Control
Each batch we ship undergoes rigorous QC validation to ensure consistency. This includes:
- SDS-PAGE and Western blot analysis for protein purity
- ELISA validation for antibody performance
- Lot-to-lot reproducibility checks
Case Study:
During COVID-19, deNOVO stepped up by launching VTM kits and a Rapid Antigen Test for point-of-care diagnostics. These innovations were recognized by the Department of Biotechnology (DBT), Government of India, and listed among the Top 75 biotech products developed nationwide to fight the pandemic.
This recognition underscored our ability to innovate under pressure and deliver at scale — a trait our global partners continue to value today.
Value for Diagnostic Manufacturers
Faster Time-to-Market
With validated reagents, manufacturers can skip months of troubleshooting and move directly into scaling their assays.
Reduced Costs
Reliable reagents mean fewer repeats, less wasted material, and more efficient R&D budgets.
Compliance Confidence
Our products are designed with global regulatory requirements in mind, supporting smoother approval processes.
The Future of Diagnostics
Looking ahead, diagnostics will demand even more personalization, speed, and affordability. We believe local suppliers like deNOVO play a critical role in:
- Strengthening regional supply chains
- Reducing dependency on imports
- Making diagnostics more accessible in developing nations
At deNOVO Biolabs, every shipment is more than a box — it’s a promise of reproducibility and trust.
If you are a diagnostic manufacturer, CRO, or research organization looking for validated reagents and assay solutions, let’s connect.
Reach out to us via our contact form to explore how our products can support your pipeline.