TB Diagnosis Needs and a Packaging Breakthrough ..... (By machiavelli10 on IHUB)
Below are two interesting pieces on tuberculosis diagnosis and the need for low cost and effective diagnostic systems that can be used at the point close to where care needs to be delivered. The second excerpt is the abstract from a recent article in an Oxford University scientific journal. The first is a Wall Street Journal article concerning the growth in TB in the US and other countries. There are also important studies by scientists in South Africa detailing the very significant needs in that country and the limitations of the XPert molecular diagnostic system and the need for a point-of-service and treatment technology that is far less expensive and easier to use.
The South African studies also emphasize the limitations of the Xpert system due to its high cost, training and personnel requirements, and the fact that it does not detect TB in children and some other potentially affected groups. The emphasis of the researchers is on the need for a complementary system of reliable diagnosis that is accurate, rapid, works in the field, and costs much less than XPert but complements that system’s capabilities. The same kind of analysis and statement of needs is at the center of a mission statement by Doctors Without Borders and several other key organizations seeking to deal with the emergent TB epidemic. Any thoughts on which company’s technology satisfies these needs when the diagnostic capability, ease of use and packaging are put together?
I raise these points because after reading the recent press release by NanoLogix concerning the performance of the nitrogen vacuum pack petri dish technology for which a patent has been applied, it appears obvious that the combination of the BNP diagnostic system with the long lasting, breakage resistant, “room temperature” storage packaging technology represents an amazing opportunity. The combined technology seems to fit the stated needs to a degree that is close to perfect.
Even with this “fit” of NanoLogix technologies in the TB areas of concern, the press release also discussed the development and testing of the packaging technology as an independent product. To me this packaging breakthrough has the potential to be something akin to the emergence of Xerox technology and the rapidity with which it replaced the mimeograph and carbon paper industries virtually overnight. In the same way that Xerox and mimeograph technologies both are “copy” functions they really are not the same. The pattern is likely to be “copied” in the NanoLogix packaging/petri dish context because the advantages that exist are an order of magnitude beyond the current approach to petri dish storage, packaging, longevity and quality. The scale of the generic petri dish market is mind-boggling.
The potential “game-changing” aspect of the NanoLogix packaging technology is something that goes beyond the specific BNP diagnostic markets for its wide range of marketing sectors because of its generic applicability across-the-board virtually all diagnostic contexts and the fact that people are already trained in the use of petri dishes and have a comfort zone. So petri dish users don’t have to change, other than being able to save on energy costs associated with refrigeration, not suffer up to a 20 percent breakage loss, not have to re-order every month or so, and not having to worry about “just-in-time” shipments arriving on time. Given that sales of petri dishes probably run well over a billion plates per year (admitted “guess-timate” because the data are hard to pin down) capturing even 10-15 percent of that set of collective markets represents both an enormous undertaking and equally significant opportunity.
We have not even really begun to understand all the possibilities for the petri dish packaging. I was just talking with a high school science teacher and mentioned the vacuum packed petri dish technology. It turned out he had spent years having to make his dishes with agar each time his class was doing a science project requiring that kind of testing. He jumped on the idea that it would save science teachers in high schools and colleges a great deal of time and produce a totally consistent and professional product for comparative purposes to have access to a product such as the unique NanoLogix petri dish. I have no doubt there are many other potential markets open to a product that doesn’t have to be refrigerated and has predictable quality for experimental use.
This in no way means that the BNP technology does not have significant market potential. Of course it does. But the packaging breakthrough is an amazing collateral development that the company is obviously aware of and for which it ought to be commended. Achieving “buy in” by purchasers for the world’s highest quality and most reliable petri dishes can be expected to contribute to the perceived legitimacy of the NanoLogix BNP and BNF technologies as trustworthy and “industry credible.” It’s all part of an integrated system in my perception.
Anyway, there are a few of my thoughts so now the “usual suspects” can spend their time showing the rest of us why we are wrong.
TB's Global Resurgence Amplifies U.S. Risk
By BETSY MCKAY, Wall Street Journal
Maria Jimenez contracted TB in San Antonio; complications made her drug-resistant.
NASHVILLE, Tenn.—Natalie Skipper started feeling under the weather a few weeks after returning home from volunteering at a South Africa hospital. "The worst flu I had ever had in my life," she said.
Her temperature hit 105 degrees. She had trouble walking.
She didn't have the flu.
Ms. Skipper, a 34-year-old physical therapist with a love of travel, was infected with tuberculosis. And not just any tuberculosis. She brought to Tennessee a strain that can't be cured with the most potent and common drugs used against the deadly disease. Multidrug-resistant TB is at epidemic proportions in some parts of the world—a growing problem the U.S. is surprisingly unprepared for.
Josh Anderson for The Wall Street Journal
Natalie Skipper caught a dangerous strain of tuberculosis while volunteering in South Africa and brought it to Tennessee.
The U.S. beat back multidrug-resistant tuberculosis in the 1990s. Today, however, a new threat is emerging as drug resistance worsens abroad and far more dangerous strains develop and spread, including some that are all but untreatable with standard drugs.
In the U.S., rates of multidrug-resistant tuberculosis remain low, but are starting to inch back up, as hundreds of millions of American citizens and foreigners alike travel to the U.S. from abroad every year. At the same time, funding and expertise are in decline.
"What's worrying me personally is that I'm seeing a resurgence of complacency," in the U.S. health-care community says Kenneth Castro, director of the division of tuberculosis elimination at the Centers for Disease Control and Prevention.
Ms. Skipper's infection took doctors more than a year to properly diagnose. First, they thought she had an nasty intestinal bug from Africa. Then they suspected pneumonia—a common misdiagnosis.
Finally, the doctors discovered she carried drug-resistant TB. That set off a scramble to trace and test everyone around her hometown of Paris, Tenn., and elsewhere with whom she might have had close contact with while contagious. Ms. Skipper had, in fact, infected someone else.
In-Depth: A Killer Quietly Gains Strength
The Wall Street Journal is chronicling the world's imperfect response to the rise of drug-resistant tuberculosis, an ancient disease that modern medicine, until recently, could defeat.
A selection of reports:
• Deadly unintended consequences: The global TB-fighting strategy helped allow the spread of new, all-but-untreatable strains. (11/23/2012)
• Exclusive numbers suggest more than 25% of patients at one Indian TB clinic don't respond to the primary treatment. (11/23/2012)
• One woman's case of nearly incurable tuberculosis echoes around the world. (9/8/12)
• India's slow reaction appears to be nurturing an all-but-untreatable strain of TB, raising the prospect of a global health hazard. (6/20/12)
• A top doctor in Mumbai reports finding 12 cases of tuberculosis that are all but untreatable by current methods. (1/19/12)
"We cannot be safe in the U.S." while drug-resistant TB is an "epidemic in the rest of the world," said Barbara Seaworth, medical director of the Heartland National TB Center in San Antonio. Outbreaks are "absolutely" possible in the U.S., said Dr. Seaworth, who has treated hundreds of patients with drug-resistant strains.
jid.oxfordjournals.org
Evaluation of Tuberculosis Diagnostics: Establishing an Evidence Base Around the Public Health Impact
1. Richard J. Lessells1,2,
2. Graham S. Cooke2,3,
3. Marie-Louise Newell2,4 and
4. Peter Godfrey-Faussett1
+ Author Affiliations
1. 1Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom
2. 2Africa Centre for Health and Population Studies, University of KwaZulu-Natal, Mtubatuba, KwaZulu-Natal, South Africa
3. 3Department of Infectious Diseases, Imperial College, London
4. 4UCL Institute of Child Health, London, United Kingdom
Correspondence: Richard J. Lessells, MBChB, Department of Clinical R
The limitations of existing tuberculosis diagnostic tools are significantly hampering tuberculosis control efforts, most noticeably in areas with high prevalence of human immunodeficiency virus (HIV) infection and antituberculosis drug resistance. However, renewed global interest in tuberculosis research has begun to bear fruit, with several new diagnostic technologies progressing through the development pipeline. There are significant challenges in building a sound evidence base to inform public health policies because most diagnostic research focuses on the accuracy of individual tests, with often significant limitations in the design, conduct, and reporting of diagnostic accuracy studies. Diagnostic accuracy studies may not be appropriate to guide public health policies, and clinical trials may increasingly be required to determine the incremental value and cost-effectiveness of new tools. The urgent need for new diagnostics should not distract from pursuing rigorous scientific evaluation focused on public health impact.
Global control of the tuberculosis epidemic is a public health priority [1, 2]. The targets for reduction in tuberculosis prevalence and mortality linked to the Millennium Development Goals and enshrined in the STOP TB Global Plan 2006–2015 will not be achieved with current interventions [3, 4]. There is an acute need for improved tuberculosis diagnostics as one critical component of the public health response to the tuberculosis epidemic.
The rapid growth of the human immunodeficiency virus (HIV) epidemic and the emergence of antituberculosis drug resistance have highlighted the major deficiencies in current diagnostic technologies both for pathogen detection and for diagnosis of drug resistance [5]. In most high-burden countries, sputum smear microscopy remains the principal tool for diagnosing active disease; however, operationally, its sensitivity for pulmonary tuberculosis can be as low as 20% [6, 7]. Sputum culture and drug susceptibility testing are available in certain settings, but their impact is limited by the long duration and complexity of the laboratory processes [8]. Additional challenges are faced in developing diagnostics for extrapulmonary tuberculosis, pediatric tuberculosis, and latent tuberculosis infection [9–11].
The STOP TB Global Plan 2006–2015 included the target that, “by 2010, simple, robust, affordable technologies for use at peripheral levels of the health system will enable rapid, sensitive detection of active tuberculosis at the first point of care” [4, p. 24]. Although this has not been achieved, there have been developments in the tuberculosis diagnostic field, and promising technologies have entered the clinical sphere [6, 12–15]. Most promising has been the Xpert MTB/RIF system, an automated molecular test that simultaneously detects Mycobacterium tuberculosis and mutations associated with rifampicin resistance [16, 17]. It is hoped that the renewed global focus on tuberculosis will in the next few years lead to the further proliferation of diagnostic technologies in parallel with advances in therapeutics and vaccines. |
