anti-fibrinogen HRP.
HERE'S A DIRECT QUOTE FROM THE 2009 2nd Qtr 10-Q, filed in August 2009:
" Although the Company has obtained approval from the USFDA to market the then current formulation of the DR-70 test kit, it has been determined that one of the key components of the DR-70 test kit, the anti-fibrinogen-HRP is limited in supply and additional quantities cannot be purchased. There are currently enough DR-70 test kit components to perform approximately 1.2 million individual tests (31,000 test kits) over the next 12-18 months. Based on current and anticipated orders, this supply is adequate to fill all orders. The Company now anticipates that it will attempt to locate a substitute anti-fibrinogen-HRP and perform additional quality assurance testing in order to create a significant supply of the current version of the DR-70 test kit.
Part of the Company’s research and development efforts through 2010 will include the testing and development of an enhanced and improved version of the DR-70 test kit. Pilot studies show that the new version could be superior to the current version. The Company has completed negotiations with a third party to take the lead on necessary clinical studies. It is anticipated that this version will be submitted to the USFDA in the latter half of 2010. "
THAT TEXT DID NOT CHANGE IN THE 10-K's AND 10-Q's until the 2010 3rd Qtr 10-Q filed in November 2010, when they added this, indicating they had found a possible replacement (substitute) ingredient:
"We will test and evaluate the performance of the substitute. If the substitute antibody has statistically better results than precedent antibody, we will need to submit to the USFDA for approval before replacement take place. If the test results show the same effectiveness as the current antibody, the new antibody is ready for use and no further USFDA approval will be required. "
WHEN THEY FILED THE 2010 10-K in May 2011, the text changed thusly:
"We have a limited supply of the horseradish peroxidase (“HRP”)-conjugated anti-fibrin and fibrinogen degradation (“FDP”) antibody component currently used for the approved Onko-Sure® test kit. Because of the limited supply of the current antibody, we have determined it is in our best interest to change to a HRP-conjugated anti-FDP antibody. We are currently screening six commercially available conjugated antibodies to substitute into the current Onko-Sure® test kit and one we produced and conjugated ourselves. The anti-FDP antibody we produced ourselves has performed well in pilot studies and will likely be used in our next generation Onko-Sure® test kit. If the antibody substitution significantly improves Onko-Sure® test kit performance, we will be required to change the reported sensitivity and specificity of the Onko-Sure® test kit. Because of these changes and modifications, we will likely have to submit a new 510(k) premarket notification application, but can continue to sell the existing kit until our current antibody supply is exhausted."
IN THE 2011 1ST QTR 10-Q filed in June 2011 the text changed to:
"We currently have two lots remaining which are estimated to produce approximately 21,000 test kits. Based on our current and anticipated orders, this supply is adequate to fill all orders in hand. Although we are investigating alternatives or outsourcing of this component so that we are in a position to have an unlimited supply of Onko-Sure® in the future, we cannot assure that this anti-fibrinogen-HRP replacement will be completed. "
THIS WAS REPEATED VERBATIM IN THE 2nd Qtr 10-Q filed in August 2011... but the 3rd Qtr 10-Q filed in November 2011 implies they had given up trying to find a replacement, and were now trying to mix the horseradish ingredient inhouse:
"Although we are investigating to produce this component in house so that we are in a position to have an unlimited supply of Onko-Sure® in the future, at this time we cannot give an estimate of time needed to complete this anti-fibrinogen-HRP replacement.”
FINALLY, IN THE 2011 10-K filed in June 2012, they said:
"In addition, our test kits require anti-fibrinogen HRP of which we have a limited quantity. Due to the lack of funds, we suspended the project of investigating alternatives or outsourcing of the anti-fibrinogen HRP to be used in our test kits. Currently, we have two lots remaining which are estimated to produce approximately 21,000 kits. In order to utilize in kits, we will need to purify and quality control the lots. We currently have enough purified and quality checked anti-fibrinogen-HRP to manufacture 200 kits. When funds are available, we will begin the quality control and purification process which will enable us to increase our raw material inventory. Based on our current and anticipated orders, this supply is not adequate to fill all such orders."
CONCLUSION: THERE IS NO REPLACEMENT FOR THE ANTI-FIBRINOGEN HRP that's been tested and verified. So how can UNI, GCDx, and the China company make the test?
