“The delivery technology used in the EDP test is virtually identical to the Corgenix base technology, so it will fit very nicely into our existing production facility,” Doug Simpson, president and CEO of Corgenix told us. “We do not anticipate any problems in moving their product into our system or our ability to meet EDP’s long term expectations.”
Although Corgenix does not manufacture any other colon cancer biomarker products like EDP’s ColoMaker, Simpson remains confident of his company’s abilities in meeting the terms of the contract.
“The issues associated with the contract manufacturing of this kind of diagnostic kit are independent of the clinical purpose,” Simpson said. “It is the platform and format which are the key considerations and we have over 20 years’ experience in manufacturing and supporting very similar products. We fully expect that the relationship with EDP will be a success for all parties.”
Long-Term Possibilities
Corgenix is also looking to take on relatively limited competition in the contract services sector for diagnostic companies, especially as more tech companies have cutting edge ideas but lack the ability to secure their space in the market.
Simpson noted that the list of diagnostic companies “is limited” in terms of those that can develop, manufacture, commercialize products, and offer contract services. He added that “most of them do this simply as a way to fill up available capacity.”
Corgenix usually takes over for a diagnostic company when they are looking to transform “a lab bench test into a product which can be consistently manufactured and commercialized.”
He added: “We are seeing more and more technology companies with remarkable cutting edge diagnostic biomarkers but with limited understanding or infrastructure to advance their technology into products which can secure the necessary regulatory approvals to establish and grow markets.”
This long-term deal with EDP also builds off of a similar deal the company made with Eli Lilly in May to advance Lilly’s proprietary diagnostic technology.
“Most of the pharmaceutical companies we have talked to neither have their own diagnostic arm, nor particularly want one,” Simpson added. “They are looking for strategic collaborations that can provide them the diagnostic products they need, perhaps tied very closely to their own pharma technology.”