Exclusive Distribution Agreement Facilitates Worldwide Access to WHO Recommended New Tuberculosis Test

Tokyo, Geneva, Wiesbaden, August 31, 2016 – EIKEN CHEMICAL Co., LTD. and FIND chose HUMAN Gesellschaft für Biochemica und Diagnostica mbH as exclusive partner for the worldwide distribution and after sales service of the innovative LoopampTM Tuberculosis (TB) and Malaria tests, outside of the EIKEN distribution area (China, Japan, Korea, Taiwan and Thailand).

TB ranks alongside HIV as leading cause of death worldwide. Low and middle income countries bear the main burden with over 95% of all TB related deaths in 20141.

Today, in resource-limited settings TB is frequently diagnosed by sputum smear microscopy as more sensitive methods are not applicable due to the lack of infrastructure and skilled personnel.

Since 2005 EIKEN, in collaboration with FIND, has proceeded in the development of an easy-to-apply, fast and sensitive TB diagnostic technology based on the molecular loop-mediated isothermal amplification method (LAMP). The thoroughly evaluated new TB-LAMP has been recently recommended by WHO2 as a potential point-of-care TB test and alternative to smear microscopy in resource limited settings. Thus, TB-LAMP is acknowledged to contribute as a further diagnosing option to the WHO End TB Strategy.

The patented LoopampTM system requires minimal laboratory infrastructure, biosafety requirements and minimal training. Patient results can be achieved within one hour.

Along with the CE IVD marked LoopampTM assay for Tuberculosis the distribution agreement covers as well the likewise certificated LoopampTM Malaria test. Detecting 4 Plasmodium species and Plasmodium falciparum the LoopampTM Malaria assay may be a practicable and more sensitive alternative to rapid immunoassay testing or microscopy in remote areas. 

According to the mission of FIND to push the access and use of innovative and effective diagnostics in low and middle income countries, the three partners EIKEN, FIND and HUMAN, agreed upon special conditions for the tests for the public sector in the respective areas3. Tests and needed instrumentation4 will be available by the end of 2016. For more information or preorders please contact loopamp-TextEinschliesslichBindestricheBitteEntfernen-@human.de.

References

1 Fact sheet TB: www.who.int/mediacentre/factsheets/fs104/en/
2 WHO recommendation TB-LAMP: www.who.int/tb/features_archive/TB_LAMP/en/
3 Special conditions for the public sector: http://www.finddx.org/find-negotiated-product-pricing/
4 Products: www.human.de/loopamp

Company Information EIKEN, FIND, HUMAN

About EIKEN

EIKEN CHEMICAL Co., Ltd. was established in 1939 and was the first Japanese company to successfully commercialize the manufacture of powdered culture media for microbiological investigations. The company has established itself as a leader in the clinical diagnostics market, and has a strong commitment to research and development toward global products and technologies that fulfill needs at the cutting edge of contemporary medicine. The LAMP technology, developed at EIKEN in 1998, is now a core technology being exploited to develop a range of products.

Contact EIKEN CHEMICAL Co., Ltd.:Public Relations Department
Email: koho-TextEinschliesslichBindestricheBitteEntfernen-@eiken.co.jp
www.eiken.co.jp/en/

About FIND

FIND, established in 2003, is a global non-profit dedicated to accelerating the development, evaluation and use of high-quality, affordable diagnostic tests for poverty-related diseases, including tuberculosis, malaria, HIV/AIDS, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease, Buruli ulcer, and infectious diseases with outbreak potential such as Ebola. Over the last decade, FIND has partnered in the delivery of 14 new diagnostic tools, including eight for tuberculosis, and created an enabling environment for numerous others through the provision of specimen banks, reagent development and better market visibility. FIND also supports better access to new diagnostics through implementation, quality assurance and lab strengthening work. FIND has more than 200 partners globally, including research institutes and laboratories, health ministries and national disease control programs, commercial partners, clinical trial sites, and bilateral and multilateral organizations, especially WHO.

Contact FINDJulie Archer, Senior Communications Officer, FIND
Email: Julie.Archer-TextEinschliesslichBindestricheBitteEntfernen-@finddx.org
www.finddx.org

About HUMAN

HUMAN, founded in 1972, is a Germany based privately owned company which develops, manufactures and distributes a wide range of IVD Diagnostics and laboratory equipment. The comprehensive portfolio of more than 400 products covers almost all areas of modern laboratory including Autoimmune and Molecular Diagnostics. With its strong network of local partners in 160 countries and with six regional offices around  the globe HUMAN maintains probably the broadest distribution & service network especially in developing and emerging countries.

Contact HUMANZinga Makumbundu, Marketing Communications
Email: Z.Makumbundu-TextEinschliesslichBindestricheBitteEntfernen-@human.de
www.human.de

LoopampTM: Clear Visual Interpretation of Test Results