FISH Can Be Utilized For Infectious Disease

Making Germs Glow - we've noticed the trend of FISH testing being used not only for its key application of cancer testing but, increasingly, for detection of infectious disease. A University of Arizona team has found that a specific type of FISH testing can reduce wait time to deliver eager patients news about bloodstream infections.

Every year, more than 875,000 patients are diagnosed with bloodstream infections in the U.S., resulting in more than 90,000 deaths and significant costs to the health-care system.  The article one company utilizing a PNA-FISH (peptide nucleic acid fluorescent in situ hybridization) technology that can provide evidence of infection in hours and not days.  FISH uses fluorescent molecules tagged to genetic sequences that match those in the microbe. When added to a dried drop of blood culture containing pathogens, sequences that find their match inside the microbe cling to the pathogens.  

These type of results will propel use of these technologies for FISH testing.  We expect competition to expand in this market as key companies like Abbott are joined by smaller concerns. 

The problem that better diagnostics can solve is not only the matter of treatment lag time and patient outcomes that one might expect - of course the patient is better served when the condition is correctly identified -but also the use of antibiotics.  In medical practice, a lag time means that more often than not, antibiotics will be prescribed, even in cases where test results might have eliminated that prescription

Next Big IVD OP? Developing World

 Rapid tests that are easy-to-use and that can provide results in high-temperature and scarce water conditions may be the next big growth opportunity in in vitro diagnostics, according to a new report by Kalorama Information.  The healthcare market research publisher describes a quarter-billion market in the next five years for tests that can detect malaria and TB – but also rarer disease like leptospirosis and chikungunya in its new report, Point of Care Diagnostics for Emerging Infectious Disease Threats, co-authored by Kalorama diagnostic market analyst Shara Rosen and Diagnostic Consulting Network President Brendan O’Farrell.

Of the seven biggest killers worldwide, TB, malaria, hepatitis, and, in particular, HIV/AIDS continue to surge, with HIV/AIDS and TB likely to account for the overwhelming majority of deaths from infectious diseases in developing countries by 2020 and the response of the international community towards the problem has created a market.  The report cites a 13% growth rate for sales of tests that treat these the most pressing health needs.  This is greater than Kalorama forecasts for most areas of the point of care diagnostics market. 

“Now that neglected diseases have come onto the radar the supply of money to deal with it has increased,” said Shara Rosen.  “For the past 10-15 years politicians and aid agencies have come to understand that infectious diseases are not merely causes of suffering and death but are also significant barriers to economic development.”

Increased funding for infectious disease diagnostics by groups such as the Gates Foundation, the Program for Appropriate Technology in Health (PATH, Seattle, WA) and The Foundation for Innovative New Diagnostics (FIND, Geneva, Switzerland) is helping to develop a new generation of sophisticated test platforms that are designed to meet the needs of low resource environments (electricity, water, refrigeration, etc.).   These efforts may go a long way to improving the detection of pathogens that are found primarily in developing countries (malaria, Chagas, Dengue and others). 

“However, the same platforms are sorely needed everywhere,” according to Rosen. “There is a huge need for user-friendly, highly specific and reliable technologies for rural and underserved communities, worldwide, and that is where the opportunity is.”

While it is a growing market, it is not a market without competitors.  Kalorama’s market research finds that there are at least 75 vendors worldwide that market rapid test kits for emerging infectious diseases.  The current market leaders are companies that have invested in sophisticated new technologies and those that have established relationships with governments and international aid agencies .

More specific market categories as well as trends and detailed company information can be found in Kalorama Information’s Point of Care Diagnostics for Emerging Infectious Disease Threats.   The report is available from Kalorama Information at http://www.kaloramainformation.com/Point-Care-Diagnostics-6429399/

Abbott Beefs Up Molecular DIagnostic Offering

Molecular tests have developed in many areas, Kalorama Information has detailed the progress in these areas.  In some cases the promise of molecular tests has not been lived up to becuase the greater efficiency and speed of the test is not cost-effective versus existing technology.  Thus despite the many available prenatal products, ultrasound is more routine practice.  Infectious disease comes with different stakes and thus our research into the business of diagnostic markets has thus far determined it is the most logical market pathway for molecular ds.  The nature of infectious disease, espeicially healthcare infections (nosocomial infection), where patients should be isolated to avoid contaminating others, where treatement regimens must be accelerated and where often a limited supply of drugs exist, had created demand for high speed molecular.   Vancomycin Resistant Enterococci (VRE) and Clostridium difficile (C.diff) are among the most potent of infections.

 A deal with Intelligent Medical Systems (IMDx)  fortifies Abbott's molecular diagnostic offering.  The IMDx C. difficile for Abbott m2000 and IMDx VanR for Abbott m2000 tests are performed on Abbott's m2000 automated molecular diagnostics system.  The tests are only sold outside the United States.  Non-Us sales have been Abbott's strongest area for some time.    The IMDx C. difficile for Abbott m2000 assay detects toxigeneic C. difficile toxin A and B genes in specimens from patients with symptoms of C. difficile-associated disease and is intended for use as an aid in the diagnosis of C. difficile.  The IMDx VanR for Abbott m2000 assay detects the presence of vanA and vanB genes that can be associated with VRE. The test is intended for use on samples from patients at risk of VRE colonization.  Abbott competes in this sector with Roche, Cephid and a few others.

Thorough Analysis Satisfies Users

In the article, "Shiny Happy Market Research Buyers," MarketResearch Beat cites a survey demonstrating increased satisfcation among users of market research.   The ponts of satisfaction include honest respondents and thorough analysis based on a user survey by MarketResearch.com, which is in a position to do this, as it distributes a vast number of different publishers each with their own approaches to research and has hundreds of thousands of loyal users.

We took note of the survey results and were pleased.  Kalorama Information attempts to provide analysis along with tabular data to place the data in context.  It does mean we probably publish a few less reports total than others in any given year, but we focus on the subjects we can speak to well.   From time to time we take note of instnaces of where other research offerings are not analyzing the market enough and merely reporting and extrapolating data which could lead to user dissatisfaction.

This is especially true with looking at today's sales in any category and assuming a future trend in it.  Maybe, but maybe not.   In one case, a healthcare research firm identified the H1N1 vaccine market in 2013, failing to consider that the vaccine would be rolled into the standard flu vaccine and there would be no H1N1 market beyond 2009.  It doesn't mean that there isn't lessons in the H1N1 market of 2009, indeed Kalorama has a title on this topic, but the simple growth projection based on current sales did the reader no service.

Another area where explanation is as important as data is in a market where there is a high growth rate but little chance of entry.  We've talked about this in the hospital EMR market.  High growth which is tempting - but can your start up staff the service that hospitals will need?  And how will you integrate with existing systems always present in a hospital.  The physician EMR area is easier to penetrate, comparitively speaking.   These are the type of distinctinons market researchers must continue to make to keep users of research happy.

Business Week - EMR a "Silicon Valley Gold Mine"

This Business Week article  details    what it calls the new "Silicon Valley Gold Rush" -EMR

It's an interesting take on the subject.  Kalorama has in many versions of our EMR report (we have been reporting yearly on electronic medical records markets since 2007) said that there is opportunity for new players - no one company has leadership.  There are large concerns involved here - Dell, WalMart, even ADP has jumped in recently.  But physicians and group practices buy individually and there's no clear favorite yet.  There is billions of dollars in the physician market. 

Having said that the larger market, almost 80% of the market Kalroama cites in its EMR market figure,  is in hospitals and there we see less of a 'gold rush' and more of a few key players in the industry - Cerner, GE Healthcare, Siemens dominant.  The only action that we see occurring in this multi-billion dollar marektis a few of the 5th, 6th and 7th position companies in the market like Epic or Allscripts may rise to top three and battle it out to become a larger player.  

HIV Testing Consent Relaxation - A Bid to Increase Volume

A Boston Globe article details how Massachusetts, one of the few states requiring a patient's written consent to perform an HIV test, is  considering dropping the requirement.  Such consent notices limit the amount of tests performed.  San Francisco eliminated the restriction in 2006 and saw testing increase from 13.5 per 1,000 patient visits to 18 tests per 1,000 patient visits. 

A proposal to change how people give consent for HIV tests has divided AIDS advocacy groups in Massachusetts and upset major medical organizations, stymieing legislators trying to bring the state into compliance with federal recommendations aimed at promoting more testing.

 

At issue is a bill that would drop Massachusetts’ requirement for specific written patient consent before a doctor tests for the AIDS virus - something 48 other states have done - and replace that with verbal consent. The measure would also require the physician note in the medical record the patient’s decision.

 Beckman Coulter, Becton Dickinson and Roche are among the companies producing HIV tests.

Pharma Technologist Article on Big Molecules

A PharmaTech Talk Blog  article on vaccines raises the point Kalorama Information often has - can these drugs be a replacement for lost patents.  From the article, which utilizes information from Kalorama's research.

Producing vaccines could be a key strategy for firms that have invested in biopharmaceutical manufacturing capacity. Market research firm Kalorama Information reported that the world market for preventative vaccines rose from $22.1 billion in 2009 to $25.3 billion in 2010. It predicts that the market will grow at a compound annual rate of 9.3% during the next five years, thanks partly to sales in emerging markets.
The vaccine market generally is regarded as having two components: adult products and pediatric products. The pediatric market is the bigger of the two—it accounts for more than half of the total market and is growing at a faster rate than the adult market, according to Kalorama.

The growth in pediatric vaccines could spur the development of new drug-delivery methods—another go-to strategy for drugmakers facing the patent cliff. Kalorama predicts that the market for needle-free drug delivery methods will grow at an average rate of 15.1% from 2011 through 2016, when it will be valued at roughly $6.2 billion. More and more children, and needlephobic adults, might benefit from products such as patches and pen injectors.