The following is an excerpt from the report. Note two items: One: "Biodine, The PCR Company..." and two: states it detects "from enriched cultures".
Bioline, The PCR Company, a wholly-owned subsidiary of Meridian Bioscience, Inc. (NASDAQ:VIVO), today announced that it has received clearance from the Therapeutic Goods Administration (TGA) for its illumigene Group B Streptococcus (GBS) test, the newest molecular product on the illumigene platform. The approval in Australia for the commercialization of illumigene GBS, comes on the heels of the recent FDA clearance in the United States.
illumigene GBS utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae from enriched cultures of women samples. The procedure is remarkably simple, highly sensitive and produces results in less than an hour, which can help in the early diagnosis and proper management of this preventable disease.
i dont know where did all the down stars go i think this is the first time in two years omar has gotten more than 2 stars, guess the thieves and pumpers are abandoning ship, the smell and stench of death is in the air
Omar said: "the smell and stench of death is in the air". Must be your breath Omar. What a bunch of girly men. The slighest downturn and skirts panic. For the handful of regulars on this board you really show your true colors and understanding of the market. Just goes to prove many have not done their dd. Just like Omars sand fleas, you cut and run at the slighest downturn. Some of you guys need to grow up, no take a refresher course on understanding markets. I for one am not panicking. So when your tired of bending over, have a seat and cross your legs. Sorry to see a new band of bashers being born. Good luck. imo
Below is summary of a 45 minutes conversation with Bret Barnhizer, CEO and Chairman of NNLX, an hour ago.
1)Volume shipment would not happen until FDA approval or acceptance of diagnostic testing production laboratory.
2)FDA approval process has not started because of lack of sufficient clinical data.
3)FDA approval is essential to liability acceptance by insurance companies. production labs would not use it without insurance..
4) NNLX is counting on research laboratory .i.e. U of Taxas, MIT etc to generate validation data.
5) The research laboratory is waiting for sufficient patients to provide data.
6)The attempt to get more data from Africa failed because the shipment was lost. It was different kit anyway.
7) The research laboratory has been helpful in process optimization.
This validation data collectionis time consuming and very expensive with NNLX funding alone. NNLX has been giving free kits for the validation.
What is wrong with NNLX marketing:
1) NNLX need to develop more foreign channels to speed up collection of validation data.
2) Giving free kits to production lab for comparative throughput analysis and collecting validation data might be a program to speed up the process.