I had a nice talk with Scott Tobin today about the prostate urine test. He was very generous with his time.
ABBOTT
I specifically asked if I was correct in my assessment that Abbott had not yet accepted the results of Phases 1 and 2 (carried out by a third party). He said that Phase 1 results have been accepted, but Abbott is still working on assimilating the results of Phase 2 and they are currently awaiting some further testing.
As we know, when both Phases 1 and 2 are accepted by Abbott the next $250,000 from Abbott will be received. And then Abbott would commence Phases 3 and 4. (See my posts #2582 and #2631.)
I asked if there was a “roadblock” but he said that although it has certainly taken longer than they expected or hoped for initially, it is still looking “very optimistic” and the evaluation process continues to advance.
QUEST
I asked if Quest will use the same data that Abbott develops. He said that to some extent the findings from Abbott will be of benefit to both parties (Abbott and Quest) but they are going down independent tracks. I meant to clearly establish if Quest could develop results earlier than Abbott (aside from not needing FDA approval for a lab-developed test) but I lost my train of thought on that.
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS
While we were discussing Quest, Mr. Tobin said that about a year and a half ago there was a modification in how CLIA regulations are interpreted. I gather these are regulations (administered at the state level?) that apply to the development of lab-developed tests. Because of that change in interpretation, labs are required to take a role earlier in the development process of tests such as ours.
“Take a role earlier” essentially means “contribute money to the process earlier” so that the lab can establish rights to the test. Because they need to pay for certain things to establish rights, a company such as Quest will want to pay a company such as HDVY earlier in the development process than in the past. Although Mr. Tobin was NOT saying that money will be coming soon from Quest, he was saying that it can be expected sooner in the development process than in the past (and should be received prior to final development of the test). He said we should “stay tuned” re receipt of money from Quest.
OTHER LABS
He also mentioned that HDVY is continuing to identify other labs that are interested in the tests and that some of these labs are “looking at the process.”
IN SUMMARY
I have to evaluate things in light of the fact that I am investing retirement money, and for me there is both positive and negative. The negative is that this is going to take a while. Of course, I already knew that because I knew we have not yet received the $250,000 from Abbott for Phases 1 and 2. The positives are that HDVY should see some money from Quest earlier than expected in the process and that testing by Abbott is continuing to advance.
