Developing a commercially viable diagnostic / IVD product is a strategy-drive process that requires regulatory awareness, market insight, and a stellar supply chain. One of the most important decisions you will make early in this journey is choosing the right supplier for oligonucleotides. The oligos inside your assay heavily influence its performance and failure limitations in functional testing.

Single Supplier

MDx companies typically require high purity, low cross contamination oligos with batch-to-batch reproducibility. Eurofins Genomics has invested heavily in equipment, capacity, and infrastructure to support the needs of this industry. Eurofins Genomics could be sourced as a sole supplier for most MDx companies, depending on the size, scale, and specifications of the project.

Using a sole supplier is appealing due to the convenience and simplicity of dealing with a single vendor. However, a prudent MDx company must weight the risk of a single supplier against the benefits as well. More information is found in the tabs.

Validating a Secondary Supplier

If you have already launched a commercial product, it might be difficult to switch suppliers due to the regulatory process and potential risk. However, regulators strongly recommend validating a secondary supplier in case your sole supplier is shut down due to unforeseen events, such as a fire or flood. We can help with that validation process. Once validated, Eurofins Genomics will have the products and processes in place to step in if an emergency occur. In conclusion, validating a secondary supplier prevents interruptions to your production process and sales flow. For more information, please see the additional tabs on this page.

For questions on how to get started, contact GenomicsUS@eurofins.com.

With over 30 years of professional experience supporting commercial companies, Eurofins Genomics can offer a holistic approach to maximize your assay or commercial product’s chance of success. Below are a few of the unique advantages that Eurofins can offer to MDx companies seeking commercialization.

1. Better oligos equate to a better assay: to make an analogy, one might think of oligos as the raw ingredients going into a receipt (assay). The better the ingredients, the better the receipt. Our proprietary synthesis technology produces higher purity oligos than most other providers, before even entering a secondary purification step.
2. Faster turnaround to accelerate the R&D and sequence design phase: to reach the market first, which greatly impacts a company’s chance of success, Dx companies must achieve sequence design lock as quickly as possible. Eurofins Genomics is the fastest oligo provider on the planet, due to our unique logistical advantages and infrastructure. We ensure your timeline is not delayed.
3. True partnership: the needs of a Dx company exceed the typical supplier/buyer relationship. You need a company which can troubleshoot issues in the sequence
4. Batch to batch reproducibility: reproducibility between bulk lots is key when ramping up to full production capabilities for commercialization. Eurofins Genomics maintains tight controls on variability, especially in areas such as concentration and volume which matter to Dx companies.
5. Regulatory Support: Eurofins Genomics' start of the art facility is accredited for ISO 9001, ISO 13485, and FDA cGMP production. Our quality assurance team is regularly audited and can provide your company the support they need in the regulatory space.

For questions on how to get started, contact GenomicsUS@eurofins.com.

Validating a Secondary Supplier

If you have already launched a commercial product, it might be difficult to switch suppliers due to risk, once the product has gone into production, and the lengthy and complicated regulatory process associated with switching primary suppliers.  However, the FDA, along with most other regulatory institutions, strongly recommends validating a secondary supplier in case your sole supplier is shut down due to unforeseen events, such as a fire or flood. You may wonder, what if my supplier shuts down tomorrow? What will I do?

For this reason, many Dx companies validate multiple suppliers for their commercial products. This decision offers several benefits:

• Mitigates risk.
• Strengthens the supply chain for critical materials.
• Price and quality comparisons.
• Highly recommended for any company which is audited by a regulatory organization.

For questions on how to get started, contact GenomicsUS@eurofins.com.

Avoiding Common Pitfalls

The process of finding an MDx oligo supplier can be fraught with questions, complexity, and uncertainty.  Common pitfalls include:

• Overlooking the importance of sequence design early in the process, specifically in terms of how it will scale for manufacturing and commercialization.
• Accurate cost modeling based on ramping up to full production capacity.
• Obfuscation of root cause analysis when troubleshooting, due to the relative newness of the sequence and other factors.

These obstacles can be avoided with proper preparation and planning, but it starts with finding the right oligo manufacturing partner that can customize its processes quickly.  MDx companies need a partner, not a vendor. They require a support system, not a supplier. For this reason, successful MDx companies tend to forge close relationships with an oligo manufacture that can customize their work stream around the regulatory and production needs of the Dx industry.

Common Questions

Which oligo supplier should I choose? Who is best fit for my needs?

Eurofins Genomics covers most probe and primer needs, including a wide range of scales, purification methods, and hundreds of modifications. If we cannot fulfill the specifications of your project, we will recommend another company who can.

Is purification needed for MDx?

HPLC purification has become a standard for many MDx companies seeking commercialization, mainly due to the sensitivity and specifications of the NGS technology used to run these assays. However, purification can be cost prohibitive in certain cases when ramping up to commercialization. Companies may be wondering, do I need purification or not?

Eurofins Genomics has invested in expanded purification capacity, so we are neutral on the topic. We can offer advice though from working with MDx companies previously. Purification is absolutely valuable when running an assay through NGS equipment, such as Illumina. The mistake that some MDx companies make is depending too much on purification to correct flaws in the sequence design. For instance in the R&D phase, purification is helpful in achieving design lock early. In a small number of cases though, purification can hide or obscure issues in the sequence design. These issues can surface later during the commercialization phase, when MDx companies turn their attention to cost modeling and services like purification are removed or brought into question. Our best advice is if a sequence fails in R&D, it is typically a sign of an inherent issue in the sequence design, not purification. An MDx company can safely add purification during the ramp up period, but rarely take it away with impact to performance.

If your assay requires purification but HPLC exceeds the parameters of your cost model, we suggest testing the sequence with HPSF purification, a proprietary purification method from Eurofins Genomics. HPSF is much more cost effective while still achieving similar results.

How much time is required to ramp up production?

It depends on the lot size. Small lots can be completed in as little as 1 month, or even a few weeks. Mid-scale lots typically range between 2-4 months. Large scale lots require forecasting and capacity planning. Please discuss these products with our experts.

If my primary supplier faced an emergency and shut down production, how quickly can I switch to Eurofins Genomics?

It depends. If Eurofins Genomics is already validated as a secondary supplier, we can begin production immediately. This minimizes down time. Furthermore, Eurofins Genomics is typically a little faster than other companies, given that our operation is set up to accommodate a wide variety of customers instead of one particular segment, which means we can deliver many, smaller lots to cover your needs in the short term, while ramping up for larger quantities.

If Eurofins is not an approved supplier already, it can take time to overcome the regulatory hurdles involved in setting up a new supplier. For this reason, we highly recommend validating Eurofins Genomics as a secondary supplier now, even if you never need to place an order, because it minimizes your risk in case of an emergency.

How do I begin a trial?

Please contact GenomicsUS@eurofins.com to set up a trial order. Typically, MDx companies use small, trial orders to test quality, pricing, and other aspects of a supplier before ramping up to full production.

For questions on how to get started, contact GenomicsUS@eurofins.com.