Battelle Report on NNLX BNP Superiority
Another poster indicated this report has just now come out and so I linked to it and read the analysis. It is extremely exciting and demonstrates the superiority of the NNLX BNP technology over other methods. I have copied and posted some excerpts from the Rogers and Choi analysis below so that interested parties can see the text and analysis for themselves. I have also highlighted some parts that reflect the specific advantages of NNLX BNP in tuberculosis detection, the authors' recognition that time really is "of the essence" in detecting TB for purposes of effective treatment, that susceptibility to TB strains is heightened even more in situations involving HIV and compromised auto-immune systems, and that ease of use, simplicity and the ability to be applied in field contexts where high-tech medical equipment is not available are vital considerations when gauging the real advantages of a technology such as the NNLX BNP. I suspect that the packaging and extended shelf life of the BNP would also play a critical role in its superiority.
In any event it seems as if NNLX is now poised to implement a strong marketing strategy. The reports indicate that sales have been occurring but with this high-level validation of the BNP technology the situation should be a gradually expanding one in which a trickle becomes a flow, a flow a stream and a stream a flood of product sales over the next year. Doing this, however, requires the hiring of someone who has extensive experience in medical marketing (not only on domestic levels but internationally) and I trust the Company understands this.
Moving the system to the next level of aggressive marketing necessitates acquisition of such a person in that defined role. And, please understand that the comment is in no way a criticism of NNLX management which has brought the Company to this pivotal point and provided (and must continue to provide) coherent strategic direction. This is a really exciting and critical moment in the Company's evolution. I expect that when the Texas Medical report "hits the news stands" that the effects will be multiplied. As to the fact that we wish all this could move more rapidly the fact is that "science takes a long time" to change, demands clear replicable and comparative proof, and there is always resistance. The Rogers-Choi report provides that proof.
Microbial & Biochemical Technology
Preliminary Evaluation of Mycobacterium tuberculosis Detection in Culture and Artificial Sputum Using a BioNanoPore Membrane and Real-time PCR
James V. Rogers* and Young W. Choi
Battelle, Biomedical Research Center, 505 King Ave, JM-7, Columbus, OH 43201, USA
Abstract
The rapid detection and diagnosis of Mycobacterium tuberculosis is critical to evaluate disease severity, efficacy of treatments and therapeutics, and public health monitoring. This study evaluated a BioNanoPore technology (BNP™ Middlebrook agar) to detect and quantitate M. tuberculosis in less time than traditional plate counting methods. BNP™ Middlebrook enabled visual detection of M. tuberculosis from actively-growing cultures and inoculated artificial sputum within 5 days; however, colonies were not visible on Middlebrook 7H10 agar. For cultures incubated in the presence or absence of artificial sputum for 19 days on BNP™ Middlebrook, M. tuberculosis ranged from 5.81-5.86 log10CFU/mL from liquid culture and 6.39-6.50 log10CFU/mL in artificial sputum; counts for M. tuberculosis in liquid culture ranged from 5.70-5.85 log10CFU/mL on Middlebrook 7H10. All colonies from 19 day-old cultures evaluated from the BNP™ Middlebrook and Middlebrook 7H10 media were positive for the Mycobacterium insertion sequence (IS) 6110 by real-time PCR. This study demonstrates that BNP™ Middlebrook can detect M. tuberculosis faster than standard plating techniques in the presence or absence of a simulated biological matrix (artificial sputum). Moreover, the BNP™ Middlebrook color development step does not interfere with real-time PCR detection of IS 6110. This study provides a preliminary assessment of the potential use of BNP™ Middlebrook for a more rapid screening and detection of viable M. tuberculosis with respect to clinical specimen evaluation, therapeutic treatment/vaccine efficacy, or epidemiological surveillance.
Excerpts from Main Text:
In healthy people, TB infection often causes no symptoms; however, in immune compromised individuals, such as those positive for human immunodeficiency virus (HIV), the probability of developing the disease is higher. The World Health Organization (WHO) has reported an estimated 8.8 million incident cases of TB globally in 2010 in which 1.1 million estimated deaths were among HIV-negative individuals and 0.35 million deaths occurred in HIV-positive people [2].
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A key element in the successful treatment and control of disease is proper diagnosis within a time window enabling the opportunity or successful treatment. Diagnostic tests aiding in appropriate treatment strategies need to be rapid, sensitive, and specific for the identification of the causative agent.
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The BNP™ technology has been evaluated for the more rapid detection and quantitation of virulent Bacillus anthracis and Yersinia pestis compared to traditional culture methods [15]. …
Discussion
Tuberculosis is a global public health concern in which early diagnosis is critical to enabling health care providers the ability to provide the necessary medical treatment in a timely manner. Although there have been advances in the available techniques to help diagnose M. tuberculosis infection, the gold standard method for laboratory is culture on semi-solid media that can require up to 3-4 weeks. Additionally, TB diagnosis relies on microscopic evaluation of acid-fast bacilli in sputum spears; however, the diagnostic sensitivity of this technique ranges from 25% to 65% compared to culturing and can vary by factors such as specimen type and number, Mycobacterium species, and staining technique [16].
Currently, there are many types of “rapid” diagnostic tests for TB that have undergone various levels of testing and evaluation as well as the post-research and development assessments describing strengths and weaknesses [1,8,23,24]. Of these, nucleic acid amplification tests (NAATs) and semi- and fully-automated liquid culture systems have improved the time to detection, accuracy, and sensitivity for determining TB load; however, NAATs are limited by their ability to distinguish between viable and non-viable organisms and results from liquid culture systems can take days to weeks [8]. It has been suggested that that no single mycobacterial quantitative technique has ideal performance characteristics and assay choice depends on the need and turnaround time [8]. Moreover, a definitive reference test is a critical component for assessing the performance of potential diagnostics [1,25]. However, an approach that combines more than one assay, such as culturing with NAATs can potentially improve TB diagnosis, ultimately leading to a positive impact on clinical care and treatment. Examples of such results using assay combinations have been observed (ELISPOT) assay and tuberculin skin test [27], and ELISPOT with adenosine deaminase levels [28].
Based on the favorable results that have been obtained using a combinational assay approach, the present study provides preliminary data for the BNP™ Middlebrook product in which viability through culturing and DNA confirmation via real-time PCR of M. tuberculosis can be achieved. The BNP™ Middlebrook technology enabled a more rapid detection of M. tuberculosis in the presence or absence of artificial sputum that was approximately 2 weeks faster when compared to the traditional culture method using Middlebrook 7H10. Moreover, the visible detection within 5 days when culturing on BNP™ Middlebrook is similar to or twice as fast as that reported for liquid cultures evaluated using semi- or fully-automated procedures [8,23,29].
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Ideally, highly accurate diagnostic tests for TB would be simple to perform, not require specialized equipment or facilities, provide rapid results for decreased time to treatment, are readily available, and cost-effective for the end user. These qualities are especially important in developing or high-TB burdened countries where the access and ability to purchase specialized equipment is limited, and number of trained personnel is low. The results of the present study demonstrate a proof-of-principal for BNP™ Middlebrook in detecting TB compared to the Middlebrook 7H10 reference test…
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