RPBIF » Topics » Competitors in Medical POC Testing Markets

This excerpt taken from the RPBIF 20-F filed Mar 31, 2009.

Competitors in Medical POC Testing Markets


  (1)

Only Troponin I and CK-MB cardiac tests at this time.

  (2)

Nanogen purchased the cardiac testing business from Spectral Diagnostics Inc. in February 2006 . All of the cardiac marker tests known to be offered by Nanogen are qualitative – i.e. they do not provide a numerical result, but rather are visually read. The NT-proBNP test offered by Nanogen is limited in its clinical range and requires a plasma sample. This leads to significant processing of the blood prior to testing.

  (3)

The Cardiac Reader measures Troponin T rather than TnI and does not measure CK-MB. This platform uses semi-quantitative technology. This limits the upper end of their NT-proBNP assay to only 20% of the entire clinical range.

  (4)

Mitsubishi Pathfast weighs 33kg, which for some would not be considered a POC system but rather a small laboratory analyzer.

  (5)

These companies sell rapid Flu tests that are visually read, require precise timing and do not require an instrument.

Certain of the competitors listed in the table above have stated their intention to broaden their category offerings. In addition to the key competitors listed above, we believe that each of the major diagnostics companies has an active interest in POC testing and, as well as being potential competitors are also potential business partners.

Biosite Diagnostics Inc. (“Biosite”) has sold a three-in-one quantitative immunoassay and reader system for cardiac markers (CK-MB, Troponin I and Myoglobin) since 1999 and is currently one of the leading participants in quantitative POC cardiovascular testing on the basis of market share, revenues and technology. In 2007, Biosite was acquired by Inverness Medical Innovations Inc. in a transaction valued at $1.68 billion. Based on published list prices for the Biosite products and data from the completed multi-site clinical study entitled “Evaluation of a point-of-care assay for cardiac markers for patients suspected of acute myocardial infarction13”, we believe that RAMP® has several advantages over the competing Biosite products including product performance and menu flexibility. These results were recently replicated in an unpublished trial.

Since 2003, Abbott Point of Care, (formerly iStat Corporation) has sold a 10-minute Troponin I test for use on the i-STAT Portable Clinical Analyzer, a biosensor based technology. In 2005, Abbott Point of Care launched a CK-MB test and in 2006, launched a POC BNP test. In addition, Abbott Point of Care offers several tests for other markers in whole blood, predominantly electrolytes and blood gases. We believe the requirement for different sample types for the i-STAT markers for heart attack (TnI and CK-MB) and congestive heart failure (BNP) is a significant disadvantage as compared to the RAMP® system.

Quidel Corporation has sold rapid, qualitative tests for the detection of Flu A and B since late 1999 and their QuickVue® Influenza A+B test since late 2003. In December 2007, Quidel announced the launch of a pilot program with Roche Diagnostics in the U.S. to utilize together the QuickVue Influenza A+B test and Tamiflu, an oral antiviral flu medication, in select U.S. markets. Binax, Inc., a division of Inverness Medical, Inc., has been selling Flu A and Flu B tests under the BinaxNOW® brand since 2002 and a combined Flu A + B test since 2004.

____________________________________________________
13
Wu AH, Smith A, Christenson RH, Murakami MM, Apple FS, Clin Chim Acta. 2004 Aug 16:346(2):211-9


29

Both of these tests have received CLIA Waived status, which allows for their use in physician office laboratories. Other tests available include ZymeTx Inc. (CLIA Waived), Becton-Dickinson and Thermo Electron Corp., which produce rapid Flu A+B tests that are not currently CLIA Waived.

Other technologies that may compete against RAMP® in the future by delivering highly sensitive, quantitative results, for some POC tests include immunosensors or biosensors and nanotechnology-based approaches. Biosensor methods use specific binding molecules such as antibodies to generate a measurable signal as a direct result of binding to their target molecule (or analyte). These technologies are extremely complex and have been under development for many years with limited commercial success to date. Immunobiosensors, to date, have limited sensitivity and are not competitive with RAMP®. Although methods of testing using biosensors and nanotechnology can be fast, they generally suffer from a significant lack of accuracy, repeatability and reliability, and can be expensive to produce. Biosensors are now in limited use for selected diagnostic applications, most notably for blood glucose monitoring using non-immunoassay methods. Nanotechnology is a relatively new and growing field that deals with the use of inert micro-etched wafers, or chips, to provide templates for chemical, biochemical, and biological processes.

Much of the research effort for recent diagnostic testing has been directed toward the development of DNA hybridization probe tests. These tests identify specific gene sequences that can be associated with certain genetically based disorders, infectious diseases and the prediction of predisposition to certain medical conditions such as cancer. Several companies, such as Becton-Dickinson and Gen-Probe Inc. are now marketing specific probe tests for infectious diseases such as tuberculosis, hepatitis, Legionnaires disease and vaginitis. DNA probe technology is useful for gene markers that have been shown to be associated with specific disease states or clinical conditions. Although more useful gene sequences are being discovered all the time, we believe they will not displace the need for high-sensitivity immunoassays; there is, for instance, no genetic change when a person has a heart attack. In addition, the RAMP® format may be applicable to hybridization probe methods if a need is found for these tests to be quantitative and at the POC.

An emerging and potentially eclipsing application of genetic testing is in the blood virus screening market. Currently, most tests for infectious diseases, such as AIDS, (HIV-1 and HIV-2); detect antibodies to the virus in the patient, which indicates exposure. While direct virus tests are not sensitive enough, genetic tests with amplification, such as polymerase chain reaction, may provide a sensitive and effective means to detect virus infection before the antibody levels rise. At this time, there are no RAMP® assays for HIV.

This excerpt taken from the RPBIF 20-F filed Jun 30, 2006.

Competitors in Medical POC Testing Markets

Company Test Market Segment
Cardiac
Markers
CHF
Marker
 Drugs of
Abuse
 
Flu and
Infectious Disease
Pregnancy /
Ovulation
Blood Gases
Biosite Diagnostics Inc. X X  X      
Abbott Laboratories (i-STAT) X (1)         X
Nanogen Inc. (2) X X        
Becton Dickenson Corporation (3)       X    
Binax, Inc. (3)       X    
Quidel Corporation (3)       X  X

(1) Only Troponin I and CK-MB cardiac tests at this time.
(2) Nanogen purchased the cardiac testing business from Spectral Diagnostics Inc. in February 2006. All of the tests known to be offered by Nanogen are qualitative – i.e. they do not provide a numerical result, but rather are visually read.
(3) These companies sell rapid Flu tests that are visually read (do not require an instrument).

Certain of the competitors listed in the table above have stated their intention to broaden their category offerings.

In addition to the key competitors listed above, we believe that each of the major diagnostics companies has an active interest in POC testing and, as well as being potential competitors are also potential business associates.

Biosite Diagnostics Inc. (“Biosite”) has sold a three-in-one quantitative immunoassay and reader system for cardiac markers (CK-MB, troponin I and myoglobin) since 1999 and is currently one of the leading participants in quantitative POC cardiac testing on the basis of market share, revenues and technology. Based on published list prices for the Biosite products and data from the recently completed multi-site clinical study entitled “Evaluation of the RAMP® CK-MB & RAMP Cardiac Troponin I Assays Versus The Biosite® Triage® Cardiac Panel, as Compared to the Dade Dimension Rxl System, Using Whole Blood From Normal Subjects and Patients with Symptoms of Suspected Acute Myocardial Infarction”, we believe that RAMP has several advantages over the Biosite product including product performance and menu flexibility.

In September 2003, i-STAT Corporation, now Abbott Point-of Care, announced that it had received FDA 510(k) clearance to market a 10-minute Troponin I test for use on the i-STAT Portable Clinical Analyzer, a biosensor based technology. Abbott Point of Care recently launched a CK-MB test and they have also announced development of a point-of-care BNP test with a planned market launch in 2006. In addition, Abbott Point-of Care offers several tests for other markers in whole blood, predominantly electrolytes and blood gases.

Other technologies that may compete against RAMP in the future by delivering highly sensitive, quantitative results, for some POC tests include immunosensors or biosensors and nanotechnology. Biosensor methods use specific binding molecules such as antibodies to generate a measurable signal as a direct result of their binding to their target molecule (or analyte). These technologies are extremely complex and have been under development for many years with limited commercial success. Although methods of testing using biosensors and nanotechnology can be fast, they generally suffer from a significant lack of accuracy, repeatability and reliability and can be expensive to produce. Biosensors are now in limited use for selected diagnostic applications, most notably for blood glucose monitoring. Nanotechnology is a relatively new and growing field that deals with the use of inert micro-etched wafers, or chips, to provide templates for chemical, biochemical, and biological processes.

Much of the research effort for recent diagnostic testing has been directed toward the development of DNA hybridization probe tests. These tests identify specific gene sequences that can be associated with certain genetically based disorders, infectious diseases and the prediction of predisposition to certain medical conditions such as cancer. Several companies, such as Becton-Dickinson and Gen-Probe Inc. are now marketing specific probe tests for infectious diseases such as tuberculosis, hepatitis, legionnaires disease and vaginitis. DNA probe technology is useful for gene markers that have been shown to be associated with specific disease states or clinical conditions. Although more useful gene sequences are being discovered all the time, we believe they will not displace the need for high-sensitivity immunoassays; there is, for instance, no genetic change when a person has a heart attack. In addition, the RAMP format may be applicable to hybridization probe methods if a need is found for these tests to be quantitative and at the POC.


34

An emerging and potentially eclipsing application of genetic testing is the blood virus screening market. Currently, most tests for infectious diseases, such as AIDS, (HIV-1 and HIV-2) and Staph A, detect antibodies to the virus in the patient, which indicates exposure. While direct virus tests are not sensitive enough, genetic tests with amplification, such as polymerase chain reaction (“PCR”), may provide a sensitive and effective means to detect virus infection before the antibody levels rise.

This excerpt taken from the RPBIF 20-F filed May 2, 2005.

Competitors in Medical POC Testing Markets

Company 
Test Market Segment 
Cardiac
Markers
Drugs of
Abuse 
Infectious
Disease 
Pregnancy /
Ovulation 
Blood Gases(1)
Biosite Diagnostics Inc.  ü ü      
Quidel Corporation      ü ü  
Abbott Laboratories ( i-STAT)  ü (2)       ü
Spectral Diagnostics Inc. (3)  ü        
Metrika Laboratories Inc.        ü  
Response Biomedical Corp.  ü        
(1)
The RAMP System cannot be used to test for blood gases, which is currently the largest part of i-STAT Corporation's market. Note that the i-STAT Analyzer is a biosensor that also allows users to run the Abbott MediSense® glucose strips.


– 34 –

(2)
Troponin I only (CK-MB announced by Abbott Laboratories as in development for launch in first half of 2005).
   
(3)
Spectral Diagnostics Inc. sells qualitative POC tests. All other companies listed in the table above sell quantitative POC tests.

Certain of the competitors listed in the table above have stated their intention to broaden their category offerings.

In addition to the key competitors listed above, we believe that each of the major diagnostics companies has an active interest in POC testing and, as well as being potential competitors are also potential business associates.

Biosite Diagnostics Inc. (“Biosite”) has sold a three-in-one quantitative immunoassay and reader system for cardiac markers (CK-MB, troponin I and myoglobin) since 1999 and is currently one of the leading participants in quantitative POC cardiac testing on the basis of market share, revenues and technology15. Based on published list prices for the Biosite products and data from the recently completed multi-site clinical study entitled “Evaluation of the RAMP® CK-MB & RAMP Cardiac Troponin I Assays Versus The Biosite® Triage® Cardiac Panel, as Compared to the Dade Dimension Rxl System, Using Whole Blood From Normal Subjects and Patients with Symptoms of Suspected Acute Myocardial Infarction”, we believe that RAMP has several advantages over the Biosite product including cost and product performance.

In September 2003, i-STAT Corporation announced that it had received FDA 510(k) clearance to market a 10-minute Troponin I test for use on the i-STAT Portable Clinical Analyzer, a biosensor based technology. The Troponin I test is the only cardiac marker assay available from i-STAT, with a CK-MB test in development estimated by i-STAT for launch in the first half of 2005; however, several different test cartridges are available for other markers in whole blood, predominantly electrolytes and blood gases. In 2003, Abbott Laboratories purchased all the remaining shares of i-STAT that it did not already own at a price of U.S.$15.35 per share for a total transaction value of approximately U.S.$392 million.

Other technologies that may compete against RAMP in the future by delivering highly sensitive, quantitative results, for some POC tests include immunosensors or biosensors and nanotechnology. Biosensor methods use specific binding molecules such as antibodies to generate a measurable signal as a direct result of their binding to their target molecule (or analyte). These technologies are extremely complex and have been under development for many years with limited commercial success. Although methods of testing using biosensors and nanotechnology can be fast, they generally suffer from a significant lack of accuracy, repeatability and reliability and can be expensive to produce. Biosensors are now in limited use for selected diagnostic applications, most notably for blood glucose monitoring. Nanotechnology is a relatively new and growing field that deals with the use of inert micro-etched wafers, or chips, to provide templates for chemical, biochemical, and biological processes.

Much of the research effort for recent diagnostic testing has been directed toward the development of DNA hybridization probe tests. These tests identify specific gene sequences that can be associated with certain genetically based disorders, infectious diseases and the prediction of predisposition to certain medical conditions such as cancer. Several companies, such as Becton-Dickinson and Gen-Probe Inc. are now marketing specific probe tests for infectious diseases such as tuberculosis, hepatitis, legionnaires disease and vaginitis. DNA probe technology is useful for gene markers that have been shown to be associated with specific disease states or clinical conditions. Although more useful gene sequences are being discovered all the time, we believe they will not displace the need for high-sensitivity immunoassays; there is, for instance, no genetic change when a person has a heart attack. In addition, the RAMP format may be applicable to hybridization probe methods if a need is found for these tests to be quantitative and at the POC.

An emerging and potentially eclipsing application of genetic testing is the blood virus screening market. Currently, tests such as AIDS (HIV-1 and HIV-2) detect antibodies to the virus in the patient, which indicates exposure. While direct virus tests are not sensitive enough, genetic tests with amplification, such as polymerase chain reaction (“PCR”), may provide a sensitive and effective means to detect virus infection before the antibody levels rise.

_______________________________
15
Biosite Diagnostics Inc. 2002 Annual Report.


– 35 –

Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki