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Clinical Lab Market In China Booming Despite Recession
Diagnostic companies looking for growth in a tough economy can still find a vibrant market for their products in China, says a leading healthcare market research publisher. IVD markets in China will grow to more than $1.5 billion in 2009, making it the world"s sixth largest IVD market. The last few years have seen market growth of 15-20%. With about 575 new hospitals opening each year and a government plan to open more than 20,000 health clinics, the lab market is booming, according to a new report, "Who is Who in Clinical Diagnostics in China (Manufacturers and Distributors Profiles, Market, Industry Overview)," from Kalorama Information, in partnership with IVD market research firm McEvoy & Farmer.
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How Much Health Care For $1 Trillion?
USA Today asks what the additional $1 trillion cost of a health care overhaul (over 10 years) will actually buy. "Although the eye-popping price tag would help boost insurance coverage to 95% or more of the public, it"s not enough to do everything advocates initially want. The proposals being shaped in Congress - including the $1.042 trillion bill unveiled by House Democratic leaders Tuesday - offer subsidies to fewer moderate-income families than originally intended, bar most workers from choosing to leave their employer-provided plans and likely drive up Medicaid costs for states." The Congressional Budget Office estimates that "at the end of a decade, 15 million to 20 million would remain uninsured."
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Randomized Controlled Trial Shows Circumcision Does Not Reduce Male-To-Female HIV Transmission
Male circumcision does not reduce the transmission of HIV from men to their female partners, according to a Lancet study conducted in Uganda, Bloomberg reports (Sargent, 7/16). The researchers recruited 922 uncircumcised HIV-positive men between the ages of 15 and 49 for the study, who were then divided into two groups - those who were "immediately circumcised" and those for whom the procedure was "delayed for two years" Reuters reports. Researchers also followed the wives and female sex partners of the men, who all were HIV-negative (Fox, 7/16). The analysis found that "18 percent of the female partners of the circumcised men became infected with the virus compared with 12 percent of the partners of men who hadn"t undergone the procedure," Bloomberg writes (7/16). Despite studies that "suggested circumcision ò€¦ can lower the rate of male-to-female virus transmission from HIV-positive men" the researchers concluded that "[c]ircumcision of HIV-infected men didn"t reduce HIV transmission to female partners over 24 months; longer-term effects could not be assessed" (Wawer et al., Lancet, July 2009).
Medical Devices

Chembio Awarded Three-Year $3MM NIH SBIR Phase II Grant To Complete DPP(R) Test For Human Leptospirosis

Chembio Diagnostic Systems, Inc. (a wholly-owned subsidiary of Chembio Diagnostics, Inc.) (OTCBB: CEMI) has been awarded a three-year $3 million Small Business Innovative Research (SBIR) Phase II grant from the United States National Institutes of Health (NIH) to fully develop, validate, and commercialize a rapid diagnostic test for leptospirosis for general use worldwide. The test will be developed utilizing Chembio"s patented Dual Path Platform (DPP®) technology together with proprietary reagents developed by Cornell University and the Oswaldo Cruz Foundation at the Brazilian Ministry of Health. Development of the test will be in collaboration with the Division of Infectious Diseases, Weill Medical College, Cornell University in New York and the Oswaldo Cruz Foundation, the largest biomedical research institution in Latin America. In the Phase I work completed in 2008, which occurred with this same collaborative group, novel diagnostic targets were identified and evaluated in a prototype test in Chembio"s patented DPP® format. The studies demonstrated that the test prototype had an overall sensitivity of 85% and a specificity of 90% using serum samples of leptospirosis patients from Brazil and Thailand. Furthermore, the DPP® prototype had a sensitivity of 78% in identifying leptospirosis in the first 7 days of illness, the "window-of-opportunity" during which initiation of antimicrobial therapy provides the greatest benefit. The lack of an effective diagnostic test has been one of the major barriers to addressing leptospirosis, a life-threatening zoonotic disease, whose global burden is estimated to be as high as 500,000 cases annually. Leptospirosis is an emerging infectious disease problem in industrialized countries such as the US, and is a significant cause of mortality and morbidity among impoverished populations in developing countries. Leptospirosis, especially in the early stage of illness, is often misdiagnosed as dengue, malaria and other causes of acute fever. The delay in detecting leptospirosis has potentially severe consequences since the disease progresses to cause life-threatening manifestations such as pulmonary hemorrhage syndrome and acute renal failure. Dr. Albert Ko, Associate Professor of Medicine at Weill Medical College, Cornell University and Visiting Researcher at Oswaldo Cruz Foundation, commented, "The collaboration with Chembio has been successful in applying the selected markers to Chembio"s DPP format. This grant enables us to complete development of the assay and make it available to health professionals and public health authorities as part of an effort in combating this important global infectious disease problem." Javan Esfandiari, Senior Vice President of R&D of Chembio, commented, "We are pleased with the recognition that the awarding of this grant by NIH provides Chembio and to our patented DPP® technology. I am most appreciative of the excellent work of Dr. Albert Ko from Cornell and Dr. Konstantin Lyashchenko, Chembio"s Senior R&D Director, as well as the rest of Chembio"s R&D team." About DPP® The Dual Path Platform immunoassay is a recent innovation in the field of rapid testing for which Chembio received a US patent in 2007. DPP® technology employs two separate and distinct membrane strips, one for the sample migration and one for the test reagents. This unique dual-flow design allows for improved control and management of the sample flow. As a result, the immunological reaction is more efficient than lateral flow tests based upon studies performed by Chembio. About Weill Cornell Medical College The Division of Infectious Diseases at Weill Medical College mission encompasses clinical care, research, and education. The Division has 50 full-time and voluntary faculty members and is responsible for the New York-Presbyterian Hospital/Weill Cornell Medical Center"s Infectious Diseases Clinical Service, the HIV/AIDS Program and the Weill Cornell Travel Medicine Clinic (WCTMC). The Weill Cornell HIV/AIDS Program provides care to ~2,000 HIV-infected persons, in addition to conducting basic and clinical research. The WCTMC is staffed by the faculty and provides travel advice and immunizations for ~3,000 persons annually, in addition to infectious diseases consultations. The Infectious Diseases Fellowship Training Program provides individualized training through faculty guidance, clinical rotations, mentored research, and didactic coursework. The Division has a cadre of internationally recognized physician-scientists who are devoted to basic laboratory and patient-centered research, education and service, both in the United States and abroad (Brazil, Haiti, India, Nigeria, Tanzania, and Tunisia). About Oswaldo Cruz Foundation Bio-Manguinhos/ Oswaldo Cruz ("FIOCRUZ") is the largest immuno-biological producer (vaccines, kits for diagnosis of infectious and parasitic diseases, and bio-pharmaceuticals, such as erytropoetin and interferon) in Latin America. With a physical infrastructure comprising nearly 600,000 square feet and a workforce of approximately 1,000, Bio-Manguinhos was created in 1976. The unit is capable of processing over 120 million doses of vaccines per year, supplying up to 30 million doses per year of yellow fever vaccine alone to meet Brazilian and export requirements. In 2006, FIOCRUZ was awarded the Prize for Best Public Health Institution in the world granted by the World Federation of Public Health. Up to 2.5 million kits are produced each year through agreements with the Health Surveillance Secretariat and the National Program on Sexually Transmitted Diseases and Aids, both from the Ministry of Health. In 2004, Bio-Manguinhos entered into a technology transfer, supply and license agreement with Chembio for one of Chembio"s rapid HIV tests, and in January 2008, entered into similar agreements for DPP® rapid tests for Leishmania and Leptospirosis, and a third agreement for a multiplex DPP® test for the confirmation of HIV-1 that could be performed at the point of care. Chembio Diagnostics


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