Results from Its First Clinical Validation Study on Nano-JETA Platform
Acrongenomics Inc. Shows Results from Its First Clinical Validation Study on Nano-JETA Platform
Friday May 6, 10:17 am ET
ATHENS, Greece--(BUSINESS WIRE)--May 6, 2005--Acrongenomics Inc. (OTCBB:AGNM - News) a Research and Development company focusing in the field of nanobiotechnology has managed to reshape key IVD molecular applications such as PCR, ELISA and Real Time PCR through its Nano-JETA(TM) technology platform, by integrating nanotechnology into molecular biology.
Acrongenomics Inc. recently conducted a clinical validation study at EuroGENET Laboratories SA to further establish its Nano-JETA(TM) technology platform in regards to Real Time PCR application, the Nano-JETA(TM) Real Time PCR.
The objectives of the study were:
a) to validate the Nano-JETA(TM) Real Time PCR via the detection
of Ep-CAM gene and beta-actin (internal control) in peripheral
blood of patients suffering from breast and colon cancer
(patients were histologically and cytologically verified), and
b) to evaluate the Nano-JETA(TM) technology platform in comparison
to conventional Real Time PCR methodology for Ep-CAM and
beta-actin respectively in regards to stability, sensitivity,
specificity and reproducibility.
The study was designed intentionally incorporating the most difficult parameters such as blind control, multi-centre clinical validation study, with variant and unidentified patient status (primary or metastatic status, follow up or on treatment).
The original number of patient samples was 250 but according to EuroGENET Labs Quality Control acceptance criteria, only 236 patient samples qualified as appropriate for participating in the study. The remaining 14 samples were rejected. Therefore, RNA was extracted from fresh blood samples of 236 patients suffering from breast and colon cancer. cDNA was produced according to both Nano-JETA(TM) and conventional cDNA protocols.
Conventional Real Time PCR and Nano-JETA(TM) Real Time PCR were performed for Ep-CAM and beta-actin. The average cycles required for Real Time PCR and Nano-JETA(TM) Real Time PCR completion were 45 and 13 respectively. Furthermore, the total reaction volume required for Real Time PCR and Nano-JETA(TM) Real Time PCR was 25microlitres and 8microlitres respectively.
Research results revealed that in the case of beta-actin (internal control) both protocols exhibited 100% specificity. Beta-actin was detectable from the 16th to 18th cycle when using common Real-Time PCR, while only 1 single cycle was required with Nano-JETA(TM) Real-Time PCR.
In regards to sensitivity, common Real-Time PCR detected 10 to the 4th cancer cells, while requiring 22 to 32 cycles. In contrast, Acrongenomics' Nano-JETA(TM) Real-Time PCR exhibited sensitivity of 10 to the 2nd cancer cells, with the use of 1 single cycle.
By using common Real-Time PCR, Ep-CAM was detected in 28 samples out of 236 (11.9% positive) and it was not found in 208 samples (88.1% negative) showing sensitivity of 10 to the 4th cancer cells as noted before.
On the other hand, by using Nano-JETA(TM) Real-Time PCR, Ep-CAM was detected in those same 28 samples -- but it was also detected in 22 additional samples (21.2%). It was not detected in 186 samples out of 236 (78.8% negative), exhibiting sensitivity of 10 to the 2nd cancer cells. This was due to the fact that Nano-JETA(TM) Real-Time PCR is one hundred times more sensitive than conventional Real Time PCR.
Acrongenomics believes that the capabilities and performance of the Nano-JETA(TM) technology platform developed by Acrongenomics Inc. could be regarded as a breakthrough application in the diagnostic market for stability, sensitivity, specificity and reproducibility.
SamirG
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Price increase is due to news announcement on independent evualation of the companies technology, also the say they can do Real-Time PCR in 47 seconds, which is un heard off.
Cheers,
Samir
Acrongenomics Inc. Further Develops Its Nano-JETA Platform
Friday March 11, 9:30 am ET
ATHENS, Greece--(BUSINESS WIRE)--March 11, 2005--Acrongenomics Inc. (OTCBB:AGNM - News) a Research and Development company focused in the field of nanobiotechnology is exploring future prospects by evaluating the technology behind existing implementations of PCR, ELISA and Real Time PCR.
According to our market research, current applications reveal certain limitations, including problems with efficiencies and cost effectiveness. Acrongenomics Inc. endeavors to overcome these limitations by introducing nanotechnology into molecular biology. Nanotechnology is beginning to generate substantial new insights into how biological systems function and is believed to hold potential advances in both the pharmaceuticals and health care industries.
Acrongenomics Inc. believes that its first application, the Neo-EpCAM(TM) Cancer detection kit provides enhanced performance as a result of its ongoing Nano-JETA(TM) platform, which combines nanotechnology with molecular biology and applies in PCR, enzyme reactions - including universal ELISA Detection Systems - and Real Time PCR.
In total, 97 different tissue samples from patients suffering from laryngeal cancer, and 82 different tissue samples from patients suffering from breast cancer were used for standardization, evaluation, validation and characterization of our Neo-EpCAM(TM) cancer detection kit. A characterization and evaluation report for Neo-EpCAM(TM) has been completed in universal PCR and ELISA.
By advancing our know-how in nanotechnology, we managed to apply our Nano-JETA(TM) platform on the detection of more markers and viral targets such as Neo-EpCAM(TM), HER1, HER2, HER3, and HER4, with the incorporation of the appropriate primers. A characterization and evaluation report has been completed in PCR and ELISA.
750 tests were performed in colon and breast cancer samples
750 tests were performed in colon and laryngeal cancer samples
250 tests were also performed in breast and laryngeal cancer samples
In essence, Nano-JETA(TM) Platform shows a potential in eliminating all known limitations of current technologies. These developments led to the reshaping of both Conventional PCR and ELISA, to Nano-JETA(TM) PCR, and Universal Nano-JETA(TM) ELISA respectively without compromising sensitivity, specificity and reliability.
Realizing the potential applications of our Nano-JETA(TM) Platform is of crucial importance in understanding its diversity. There is a large number of possible permutations waiting to be explored, and therefore Acrongenomics has evolved Nano-JETA(TM) Platform in Real-Time PCR application for "markers" such as EpCAM, HER1, HER2, and vEGF by conducting clinical validation trials in 400 samples of breast, colon, lung and ovarian cancer anticipating completion by the end of March 2005. Preliminary indications reveal precision, accuracy, specificity and reproducibility.
By evolving our proprietary technology, we have currently achieved a typical Real-Time PCR in 47 seconds without compromising sensitivity, specificity and reliability.
Nano-JETA(TM) platform as an application for Real Time PCR uses common Real Time PCR equipment revealing qualitative results even from the first cycle reaching maximum performance at the eighth cycle.
In addition, with such achievements and in order to strengthen our position, we have decided to conduct independent validation studies in U.S.
Molecular diagnostic testing is the fastest-growing segment of the in vitro diagnostics industry. The last four years, clinical market for molecular diagnostic products has increased from $1 billion in 2000 to 2,8 billion in 2004 and sales are expected to exceed $5 billion by 2008 (Biotechnology Associates). So profitable is the molecular diagnostics market that pharmaceutical and biotechnology companies are highly focused in developing tests that can be used to guide prescribing, and individualize patient treatment
