I think the new PR is very good news. Don't underestimate the power of this news. Yes, it is true - this is not production news, or profits or sales news, but it is good news!! Yes, TNZ, this may not affect valuation, maybe not even the PPS. However, this shows that they are moving to larger scale sales - this is the packaging of the product.
It is like a pop-tart - they patented the filling and the pastry - but now they are putting it together and putting it in foil and boxes ready to go to the store to sell. NNLX technology has been there but this proves they are moving and getting ready to sell more larger scale.
We buy rapid strep and flu test kits at our office. They include a solution, test strips, control solution, sterile Q-tip and test tubes. We don't buy each thing separately - we buy it as a packaged kit. However, this are for detection and are not live culture kits for anti-biotic sensitivities. This would be the first test-kit of this nature and would package it for mainstream use. This is really big - great news NNLX
Don't underestimate this news as a step towards sales!!
OK, I see. I agree the part we don't know is what they are doing with the results - saying the patients do or don't have GSB, or merely doing tests as compared with another method. Still, I agree it is good to be actually used - study or otherwise, and hopefully the study helps us build credibility on top of Battelle, etc. Thanks for your thoughts Jason.
Of course I have no way of knowing with confidence what that means, but I take it to mean that pregnant woman are asked to participate in a study the control being that an accepted means of detecting GBS is also used to confirm any results. Does that sound as thouugh it could be what the report meant?
All I meant to say was that the kits are a good sign. Kits are often used in medical practice so I thought this was a good sign.
Your question is valid - I don't know the study design and specifics. I have authored a number of papers published in journals in the past. I know that the specifics of the study design are generally not availble to the public until the study is complete and published. I could be wrong - maybe they are not using the plates to diagnose actual patients-I don't know the specifics.
However, the article states "NanoLogix Inc. offers its BNF technology in controlled testing at the University of Texas-Texas Medical Center in Houston for the bacteria Group B Streptococcus (GBS) in pregnant women. Early results show NanoLogix BNF technology detects GBS in roughly 2-6 hours, as opposed to traditional Petri culture methods, which can take 72 hours or longer."
Controlled testing in pregnant women could mean a number of things. likely means they are taking samples from pregnant women and testing them with BNF. What they are doing with the results - I don't know. I don't know the specific study design - but I know medical studies have to undergo very stringent and specific rules and regulations
<< "The kits prove that they are close to moving to the next major step in the market. I was waiting for this step to happen - this is a good sign. I think they are ready to go-based on the fact that they are already using them to diagnose actual patients at TMC." >>
TMC is using them to diagnose ACTUAL patients? I must have missed this. Can you expand on this statement? I was under the assumption it was just testing. Can it be diagnostic AND just testing? If they are using them to diagnose ACTUAL patients, what does that say about FDA approval?
This may help you to understand what it means to register an establishment for devices listed as there being manufactured. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM185877.pdf
I haven't checked to see if that is the most current guidance document.
You may want to ask Barnhizer or your own attorney what "filed and received medical device registration approval from the U.S. FDA for their BNP™ BNF™ and BNC™ test kits. Registration number: 3005553828" means."
For someone else's view of what it means see http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_N/threadview?bn=73175&tid=23902&mid=23930
There has been no release to the effect that any device has received FDA approval or 501(k) clearance of which I am aware. But check with Bret.
Well, I don't use any diagnostic tests that do not have FDA approval. I could be wrong - but I thought that it already received FDA approval? Correct?
Wednesday, June 30, 2010
NanoLogix has filed and received medical device registration approval from the U.S. FDA for their BNP™ BNF™ and BNC™ test kits. Registration number: 3005553828.
Copyright 2010 NanoLogix, Inc All Rights Reserved
Anyway, it is true, I am a good physician and it is true I don't understand the everything about the fine language of FDA Approval. I think you commented on it before.
I am not sure if I answered all your questions. If the NNLX BNP plate does not have official approval yet by the FDA - I do not think it will be hard for them to get especially considering that the petri dish culture has been approved for ages and this is a similar type of test. I thought it was FDA approved already according to their website. But I am not sure of the legalities. This is just my opinion-not any official company news.
Jason, I appreciate your opinion and you may be a great physician, but do yourself a favor and talk to someone about using diagnostic procedures lacking FDA clearance or approval. Then ask CMS or any health care insuser if it covers them.
Why did you fail to reply to my post about the difference between a physician utilizing a procedure and a manufacturer marketing it fot an unapproved/noncleared use?
Perhaps it was because of the star campaign.
TIA for your reasoned reply.