Regardless of the indication, complexity, and technology involved in your molecular diagnostic assay, the steps you will take are fairly consistent. Your product vendor should have the experience and the ability to partner with you in each of these steps to help you get through the process smoothly.
Just like in dating, choosing the right partner for molecular diagnostic development can be difficult and frustrating. There’s a lot that goes into assay development, but the right partner can help make this process a breeze. Also as in dating, you should have a list of non-negotiables when seeking out your perfect match. Here are five things you should look for in that special someone for your molecular diagnostics needs.
1] Choose a Partner Who Complements You – They say Opposites Attract, For a Reason!
In relationships, it’s important to find a partner who complements your skills. You want to be in a relationship where you can learn from each other. It’s best to find someone that can not only challenge you, but help fill in the gaps and complements your needs today and as your company evolves over time.
You may be thinking about regulatory submission, or manufacturing and packaging for your final product. If your organization doesn’t have that expertise internally, you should find a partner who does. Thermo Fisher’s dedicated molecular diagnostics support team can bring in specialists for every step of product development, and can even assist you in configuring your assay into a kit.
“The broad range of genetic analysis products, including Ion Torrent™ next-generation sequencing instruments, is only one of the many reasons we chose Thermo Fisher Scientific as our strategic partner for developing molecular diagnostic tests. Its dedicated team—including field engineers, bioinformaticians, key account managers, CFDA registration experts, and global leaders—has been a great resource in helping us expand our business.” —Junquan Xu, President, CapitalBio Technology
2] Choose a Partner Who Has a Lot to Offer You – Sharing is Caring
You deserve nothing less than a partner who will spoil you and knows exactly what you want: cooks your favorite dinner when you return home tired, takes care of you when you fall ill. The right partner has a lot to offer and knows exactly when you need it most.
Molecular test developers and their end-users highly value having most components from the same supplier, because each component is optimized to work together seamlessly. Still, the right products, from sample prep to analysis, need to be selected uniquely to tailor to your custom needs. Your partner should also be able to help you select which products to use for each step of their workflow.
For instance, Myriad Genetics had been using Thermo Fisher Scientific’s qPCR products for laboratory developed tests and later decided to pursue a regulated kit model. Thermo Fisher Scientific’s Custom Services Team supported their workflow optimization and bridging studies to adapt the test to 96-well format for CE-IVD clearance. This R&D partnership provided them with all the components they needed to develop an optimized assay.
“The quality and performance of Applied Biosystems™ master mixes and custom oligos are key for our diagnostic kit development. The Thermo Fisher Scientific team provided us with a one-stop solution for the entire process—from kit design, assay optimization, and test validation, to partnering on the development of our commercialization strategy.” —Patrick Burke, Executive Vice President, Emerging Products, Myriad Genetics
3] Choose a Partner Who Plans for Your Future Together – Motivation and Inspiration Fosters Creativity
It’s important that your partner think about your future together, whether it’s where to live, jobs, kids… Most importantly, they should think about different challenges that could arise and how you will handle them. Collaboration, communication, and foresight are key to successful partnerships.
Someone that motivates, inspires, and supports you on your journey, can help bring your current and future projects to life. A partner that has experience through the journey can help guide you on your development process and help avoid pitfalls, enabling a smooth-sailing ride. As a large supplier company we have visibility into many of the challenges and pitfalls our customers face and can help them plan ahead. We consider the technical and non-technical aspects of assay development, and how they impact your profitability and timeline.
A molecular diagnostics company originally engaged us to secure a custom mastermix. We reviewed their commercialization plans and presented our mastermix options based on their workflow and assay design along with potential IP implications. It turned out the mastermix to be evaluated falls under IP set to expire a year after their planned commercial launch. This finding would mean unexpected costs in the form of royalties and licensing fees, or delaying commercial launch. Understanding these implications ahead of time helped them reframe their financial model.
4] Choose a Partner Who is Flexible – Someone Who Will Meet Your Unique Needs
In dating, it’s a red flag if someone is rigid and stuck in his or her ways. Your partner should be willing to get out of their comfort zone and try new things to cater to your lifestyle.
In developing a commercial product, you may notice that the raw materials you need are not always available. Every technology and assay is unique. Some components of your workflow need to be customized, in terms of formulation, size, and packaging. The right partner will work with you to develop and manufacture a customized solution to meet your performance, cost, workflow, and regulatory needs.
An infectious disease kit developer was creating assays that were particularly sensitive to any residual nucleic acid (NA) that may carry over from the enzyme expression system. They had tested enzymes from multiple suppliers that were supposedly NA-free, and found all these enzymes to contain too much residual NA. To address this customer’s need, our Bioscience Center of Excellence in Vilnius, Lithuania manufactured a novel and stringent purification method to remove residual NA from Maxima H- reverse transcriptase.
5] Choose a Partner With a Good Reputation – And Some Life Experience
It’s always more attractive when a potential mate has some life experience. Maybe they’ve lived abroad, or worked in a lot of interesting jobs. That type of exposure to different situations will make them a better and more global partner to you.
We have over 4300 regulated products on the market in the US, EU, and Asia Pacific and over 55 regulatory professionals across the globe. Our regulatory experience includes medical devices, in vitro diagnostics, clinical trials, and companion diagnostics. Our regulatory professionals can help you navigate the regulatory landscape and develop regulatory strategy.
Asuragen sought US FDA clearance for the QuantideX®-qPCR BCR-ABL IS kit for the monitoring of molecular response in Chronic Myeloid Leukemia (CML) patients. The assay was developed and cleared on our Applied Biosystems 7500 Fast DX Real-Time PCR Instrument, along with assay-specific reporting software. We provided regulatory authorization letter for FDA to reference the 7500 Fast Dx instrument DMF, and supported Asuragen’s interaction with the FDA. Our agreement also included a quality agreement, including change notifications and complaint handling.
There is a lot to consider when developing a commercial assay. It’s difficult enough to optimize your workflow, but then you have to think of upstream implications, such as IP and regulatory factors. Don’t try and navigate these alone – select a partner with the experience to support you in each of these steps, and someone who can advise you about the pitfalls ahead and how to best tackle or navigate through them.
If you are considering a partnership or have questions, please let us know in the comments section below or visit us at thermofisher.com/MDxOEM
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