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Assay patenting instead of gene patenting to support diagnostic test development

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Interesting point regarding alternative to gene patenting for diagnostics: assay patenting instead.

“In the drug space, people have very clearly figured out that the most airtight patents are around the molecules themselves,” says SV Bio’s Stephan. “Even if that molecule targets a gene, no one would argue that you’d need to have the gene patented in order for that patent to stand on its own.” We should take that model and apply it to diagnostics, he says, where the patentable discoveries are not genes, but new test kits that probe for genetic conditions or predispositions to certain diseases better and faster than previous technologies. That’s how you foster innovation and how you assuage the field that the market is going to be okay, Stephan argues.”

Gene Patents Are Sabotaging the Future of Medicine | Wired Business | Wired.com.

It would indeed be nice to see more investment in innovative assay technology, particularly on the protein side.

One interesting area to explore is the use of panels of analytes for which cleared or approved tests already exist. OVA1 from Vermillion is one example of this approach. The test “system” uses a set of assays that are already available from Siemens and Roche and software developed by Vermillion to interpret the results. Vermillion is in truth a software company, at least with respect to this product.

Vermillion successfully received de novo clearance for its assay, albeit after 15 months of regulatory review. It would be interesting to know if other such tests are under development, and how much more efficient clinical validation is when an approach such as this is used. At the very least such software-based approaches would have more defensible competitive advantages.