A Medical Device Daily

Toyota Tsusho America (New York) and Nippon Kayaku (Tokyo) have formed a new company, GlycoMark, located in New York and the Piedmont Triad Research Park in Winstom-Salem, North Carolina.

Toyota, Nippon, and the BioMarker Group (Kannapolis, North Carolina) have worked together as partners to commercialize the GlycoMark diabetes blood test over the past few years prior to establishing the new company. With increasing clinical acceptance and commercial success of the GlycoMark blood test, a solid foundation has now been built to position GlycoMark, as a leader in the field of diabetes diagnostics, according to Toyota and Nippon.

"The GlycoMark blood test is being increasingly utilized in clinical practice to manage patients with diabetes and in clinical drug studies," said John Buse, MD, PhD, director of the diabetes care center at the University of North Carolina School of Medicine (Chapel Hill). "The test is particularly useful in monitoring moderately controlled patients, where GlycoMark may be more dynamic than the gold standard hemoglobin A1C test in reflecting glucose levels, according to some recent studies."

Eric Button, president and co-owner of GlycoMark, said the company has already achieved several key clinical and commercialization milestones for GlycoMark and the success of the test has put the company in a strong position to transform testing for diabetes, a near-epidemic in the U.S. and worldwide.

Such milestones include:

FDA approval.

Numerous research publications in medical journals; being featured as a premier diagnostic test by Quest Diagnostics (Madison, New Jersey) and LabCorp (Burlington, North Carolina).

Being highlighted as an American Diabetes Association (Alexandria, Virginia)-sponsored symposium at its 2008 annual meeting.

A recent study by Eli Lilly (Indianapolis) of more than 2,000 patients from 11 countries, indicating that GlycoMark reflects glycemia better than the current gold standard, Hemoglobin A1c, in moderately controlled diabetic patients.

Inclusion in the International Diabetes Federation (Brussels, Belgium) Global Diabetes Care Guidelines.

Establishment of a scientific advisory board comprised of diabetologists worldwide.

The new company will focus initially on the continued commercialization of the GlycoMark laboratory test with partner reference laboratories in the U.S.

Preparations are underway for introduction of GlycoMark internationally, including the European Union.

The new joint venture company also is developing a point-of-care and home-test version of the GlycoMark test.

Toyota Tsusho America says its seven operating divisions (Chemicals, Metals, Machinery & Electronics, Logistics, Automotive, Food, and Consumer Products) pursue a broad range of activities which combine international trading functions with domestic source and supply activities, supply chain and logistics services, and processing and manufacturing functions in both the industrial and consumer sectors.

Nippon Kayaku is a comprehensive fine chemical manufacturer, which had been established in Japan in 1916 and has continued to expand into a broad range of new fields including explosives, dyes, pharmaceuticals, in vitro diagnostics, agrochemicals, functional products, catalysts, and automobile safety parts.

In another new venture, Cellumen (Pittsburgh), which calls itself the Cellular Systems Biology (CSB) company, said it has spun out its personalized medicine unit, which will be called Cernostics Pathology.

The objective of this new company is to become the leading provider of digital imaging pathology and tissue-based diagnostics products and services applied to personalized medicine, Cellumen said. Cernostics Pathology will build upon Cellumen's current collaborations, including the partnership with the Mayo Clinic and Foundation (Rochester, Minnesota), in developing an advanced breast cancer diagnostic and theranostic test.

"Cellumen's successful application of [CSB] to drug discovery, drug development and personalized medicine over the last three years has yielded strong interest across each of these application areas," said CEO D. Lansing Taylor, PhD. "As a result, we are spinning out our personalized medicine unit to better address the market demands. Cernostics Pathology will focus on digital imaging pathology and personalized medicine using Tissue Systems Biology, which is CSB applied to tissues."

AMedical Device Daily

Toyota Tsusho America (New York) and Nippon Kayaku (Tokyo) have formed a new company, GlycoMark, located in New York and the Piedmont Triad Research Park in Winstom-Salem, North Carolina.

Toyota, Nippon, and the BioMarker Group (Kannapolis, North Carolina) have worked together as partners to commercialize the GlycoMark diabetes blood test over the past few years prior to establishing the new company. With increasing clinical acceptance and commercial success of the GlycoMark blood test, a solid foundation has now been built to position GlycoMark, as a leader in the field of diabetes diagnostics, according to Toyota and Nippon.

"The GlycoMark blood test is being increasingly utilized in clinical practice to manage patients with diabetes and in clinical drug studies," said John Buse, MD, PhD, director of the diabetes care center at the University of North Carolina School of Medicine (Chapel Hill). "The test is particularly useful in monitoring moderately controlled patients, where GlycoMark may be more dynamic than the gold standard hemoglobin A1C test in reflecting glucose levels, according to some recent studies."

Eric Button, president and co-owner of GlycoMark, said the company has already achieved several key clinical and commercialization milestones for GlycoMark and the success of the test has put the company in a strong position to transform testing for diabetes, a near-epidemic in the U.S. and worldwide.

Such milestones include:

FDA approval.

Numerous research publications in medical journals; being featured as a premier diagnostic test by Quest Diagnostics (Madison, New Jersey) and LabCorp (Burlington, North Carolina).

Being highlighted as an American Diabetes Association (Alexandria, Virginia)-sponsored symposium at its 2008 annual meeting.

A recent study by Eli Lilly (Indianapolis) of more than 2,000 patients from 11 countries, indicating that GlycoMark reflects glycemia better than the current gold standard, Hemoglobin A1c, in moderately controlled diabetic patients.

Inclusion in the International Diabetes Federation (Brussels, Belgium) Global Diabetes Care Guidelines.

Establishment of a scientific advisory board comprised of diabetologists worldwide.

The new company will focus initially on the continued commercialization of the GlycoMark laboratory test with partner reference laboratories in the U.S.

Preparations are underway for introduction of GlycoMark internationally, including the European Union.

The new joint venture company also is developing a point-of-care and home-test version of the GlycoMark test.

Toyota Tsusho America says its seven operating divisions (Chemicals, Metals, Machinery & Electronics, Logistics, Automotive, Food, and Consumer Products) pursue a broad range of activities which combine international trading functions with domestic source and supply activities, supply chain and logistics services, and processing and manufacturing functions in both the industrial and consumer sectors.

Nippon Kayaku is a comprehensive fine chemical manufacturer, which had been established in Japan in 1916 and has continued to expand into a broad range of new fields including explosives, dyes, pharmaceuticals, in vitro diagnostics, agrochemicals, functional products, catalysts, and automobile safety parts.

In another new venture, Cellumen (Pittsburgh), which calls itself the Cellular Systems Biology (CSB) company, said it has spun out its personalized medicine unit, which will be called Cernostics Pathology.

The objective of this new company is to become the leading provider of digital imaging pathology and tissue-based diagnostics products and services applied to personalized medicine, Cellumen said. Cernostics Pathology will build upon Cellumen's current collaborations, including the partnership with the Mayo Clinic and Foundation (Rochester, Minnesota), in developing an advanced breast cancer diagnostic and theranostic test.

"Cellumen's successful application of [CSB] to drug discovery, drug development and personalized medicine over the last three years has yielded strong interest across each of these application areas," said CEO D. Lansing Taylor, PhD. "As a result, we are spinning out our personalized medicine unit to better address the market demands. Cernostics Pathology will focus on digital imaging pathology and personalized medicine using Tissue Systems Biology, which is CSB applied to tissues."