Shimadzu, Toppan and Third Wave Sign Agreement for Point-of-Care Instrument
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Shimadzu Corp., Toppan Printing Co. Ltd. and Third Wave Technologies Inc. have announced that the companies have signed an agreement for the development and commercialization of a point-of-care instrument that could bring molecular diagnostics to the doctor's office.
The instrument is designed to analyzing a patient's DNA for specific gene sequences from a drop of whole blood in approximately 90 minutes.
Shimadzu and Toppan developed the instrument in partnership with Dr. Yusuke Nakamura of the RIKEN Institute/University of Tokyo. It employs his polymerase chain reaction, or PCR, multiplexing know-how, Shimadzu's AmpDirect reagents for performing PCR on whole blood, and Toppan's consumable chip platform.
Under the agreement announced the companies will apply Third Wave's Invader® chemistry to the instrument for detection of variations in cytochrome P450 genes that can cause adverse drug reactions.
The companies anticipate commercializing a research-use-only, or RUO, version of the instrument before the end of 2006.
Third Wave has exclusive marketing rights for the instrument in the United States, Canada and Europe, and will determine if U.S. Food and Drug Administration clearance or approval is required prior to commercialization in the United States.
Shimadzu and Toppan have exclusive marketing rights for the rest of the world. Third Wave will be the exclusive worldwide supplier of Invader® reagents for the instrument.
"My academic team's commitment has been to lay the scientific groundwork for improving health and wellness through understanding the genetic foundations of disease and drug response," Dr. Nakamura said.
"It is a pleasure to see that our discoveries may make a real impact on patients' quality of life. In our lab, the three companies' technologies worked extremely well together and the resulting instrument should be very accurate and easy to use."
"This combination of leading technologies in nucleic acid chemistry, instrumentation and chip design offers significant advantages in bringing genetic analysis closer to patients and doctors," said Shigehiko Hattori, president and chief executive of Shimadzu Corp.
"Together with its partners, Shimadzu is committed to realizing this concept by bringing to bear its significant expertise in instrument development."
"The Invader® chemistry is a promising technology and the joint development and commercialization agreement with Third Wave and Shimadzu will expand the market opportunity for Toppan," said Hideaki Kawai, chief technology officer of Toppan.
"We hope that the chemistry, instrument and chip set will become a world standard for molecular diagnostics."
"Third Wave is very pleased to be continuing our relationship with Dr. Nakamura and partnering with the world-class Shimadzu and Toppan organizations," said Kevin T. Conroy, president and chief executive of Third Wave.
"We believe the development and commercialization of this innovative, new instrument will further enable the growth of personalized medicine by facilitating expanded access to and distribution of Third Wave's Invader® chemistry."
