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Reselling a supermix/enzyme in a commercial diagnostic kit

IVD licensing supermix taqman

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#1 brofu

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Posted 21 February 2014 - 10:05 PM

Hi there,

I recently started working at a diagnostic start-up company. We're making multiplex probe-based qPCR assays to detect infectious diseases. We have primers and probes, we've optimized concentrations and thermal cycling protocols, and tested our assays with patient samples (purchased from a clinical lab). We've confirmed that our assays work and that they give results consistent with culture tests. We know that our assays work on the AB 7500 and want to sell kits to our customers as "research use only" products. 

 

The thing is, we used a commercial supermix to do all of our assay development (2x Kapa Fast Multiplex Probe Kit). Can we simply include the Kapa supermix in our kits since we already purchased it? Or do we have to get some kind of license, or extra permission? We are a very small company, and none of us know the legal details about using other companies' products inside our kits. Also, we purchased our primers and probes from IDT- can we resell their primers and probes in our kit, or do we need a license or special permission to do this?

 

We're very lost, any advice on this would help greatly. Thanks for reading!

 

 



#2 bob1

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Posted 22 February 2014 - 01:35 AM

You would need license from the companies to on-sell stuff.  For this privilege you will need a contract of some sort and probably have to pay a licensing fee



#3 brofu

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Posted 22 February 2014 - 07:50 PM

Thank you. Yes, it turns out you are correct. 

 

It was our R & D consultant who assured us that we could use commercial reagents in our kits without any issues. Turned out he was dead wrong! Now, we will have to get license to use the enzymes and dyes that we want to use. Worst case scenario, we will have to redesign some assays with different dyes.







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