James, all I'm saying is Roche's license is clearly spelled out as central labs (hospital), blood banks ( ususally within the central lab, but would include satellite blood banks near the ER or enities that only do blood banking outside the hospital), and reference labs.|
POC is said to be specifically excluded and lists examples such as tests done in the ER, on the hospital floors and ICU's, doctor offices, etc. Evidence of the strength of the license is Igen's injunction against Roche.
Yes, POC will eventually include pocket instruments that could be carried around and will controlled by the lab to insure appropriate quality controls are followed. Results will eventually be transmitted by noninterfering signals ( to prevent interference with other instruments) to a computer and placed on the patients record.
To put it another way, hospital instruments are divided into those placed in central labs and blood banks====and those placed in POC settings.
Roche's current license doesn't allow them to place POC instruments, and POC is defined as the SETTING or location where the test is performed. This is a well known concept by laboratory people. POC testing is typically performed by non-lab personnel, but this has nothing to do with the definition of POC. For Roche to sell POC instruments, they have to get a license from Igen. Once they have the license, they have to buy all reagents from Igen (no royalty since Igen will make it's money from reagent sales--Roche's current license for central labs has them making their own reagents and paying a royalty to Igen).
Organon technica is selling a HIV quantative test to measure viral load, in Europe. OT has a specific license to use origen technology for certain viral detection uses and nucleic acid measurements. I think FDA approval is pending, or about to be submitted for consideration, for sale here in the US. Igen did make the instruents, and I think some of the reagents to OT, but sold them at cost until OT could take over production. (This is one of the reasons for the appearance of falling revenues, but these were a wash and did not produce a profit). Now that OT has taken over production, any increase in sales for these instruments and reagents will also show an increase in royalties. OT uses NASBA technology plus origen technology together, and this shows Igen's ability to manufacture instruments customized for a partner. Igen also makes the origen analyser which is in most of the major labs. Now they are about to introduce the high thruput instruments and will be the supplier for reagents. POC instruments will probably use the ECLM, but the partner may choose to manufacture the rest of the instrument, but Igen again will supply the reagents.
I can see from your comments that the concept of central labs and POC is not always clear to those outside of the culture, but the separation has always been very clear in the lab and medical community.