Announcing the Release of Banalyst^®Ace, a Safe, Rapid and Easy Microvolume Blood Testing System

- Employing the world’s first μTAS measurement chip based on liquid reagent -

September 30, 2008

Ushio Inc. (head office: Chiyoda-ku, Tokyo; president and CEO: Shiro Sugata; hereinafter, Ushio), ROHM Co., Ltd. (head office: Kyoto-shi, Kyoto; president & CEO: Ken Sato; hereinafter, ROHM) and Sanwa Kagaku Kenkyusho Co., Ltd. (head office: Nagoya-shi, Aichi; president & CEO: Kazuo Yamamoto; a member of the Suzuken Group; hereinafter,SKK) have just completed the joint development of Banalyst ^®Ace, a microvolume blood testing system using the world’s first μTAS (micro tas)*1 measurement chip based on liquid reagent. The three parties have reached a decision to launch the product throughout Japan on October 30, 2008.

Plans are in place for the launch of Banalyst Ace CRP, with an analyzer and a CRP measurement chip for normal concentrations, on October 30, 2008. The launch of Banalyst Ace hsCRP with a CRP measurement chip for low concentrations is planned for December 2008 and the launch of Banalyst Ace Hb A1c with a hemoglobin A1c measurement chip, a marker for blood glucose control in diabetes mellitus, is planned for around spring 2009.

For the initial fiscal year (from October 2008 to March 2009), the companies set the target sales at 80 analyzers and 40,000 measurement chips for the two types (representing the consolidated sales of Banalyst Ace CRP and Banalyst Ace hsCRP).

Items measured	Clinical significance	Department
CRP (for normal concentrations)	Inflammation marker (identifying the degree of inflammation in infections, rheumatism, pneumonia and others)	Pediatrics internal medicine
CRP (for low concentrations)	Inflammation marker (identifying the degree of slight inflammation in arteriosclerosis, colon cancer and others)	Internal medicine
Hemoglobin A1c	Blood glucose control marker in diabetes	Internal medicine

Conventional large analyzers require the collection of 1 ml of venous blood for adults and 0.5 ml for newborns as the plasma and blood cells had to be separated from whole blood before examination. For newborns, in particular, frequent examinations were not permitted because of the need for a large quantity of blood compared to the body weight. By enabling examinations with such a small amount of blood as 4 μl, Banalyst Ace CRP enables blood collection from fingertips and earlobes, drastically alleviating burden on patients. (One microliter, 1 μl, equals 1/1000 ml; the quantity corresponds to 1/250 of the quantity for adults and 1/125 of the quantity for newborns compared to the old analyzers.)

Specimens that may be contaminated with infectious substances will not leak from the measurement chip. The user can discard the measurement chips without touching the specimen after measurement.

Banalyst^®Ace allows the user to perform the measurement simply by attaching a measurement chip with the specimen injected in the analyzer and pressing the Start button. The product can be used even if a clinic has no clinical laboratory technologist.

Unlike measurements done by external laboratories, the product immediately displays the results of its high-precision examinations. This allows institutes to give diagnosis, instructions about lifestyle and medication, thereby allowing the product to be used in the new health check system for metabolic syndromes,*3 diabetes tests and the area of inflammatory diseases.

Unlike conventional POCT devices,*4 the product is equipped with a centrifugal blood cell separation function. In addition, it utilizes the same liquid reagents as those used by large analyzers, an exhibits favorable correlation with large analyzers and examination results despite its compact size.

While currently permitting three test items (two types of CRP and hemoglobin A1c), the product will enable up to ten test items after employing measurement chips to be developed in the future.

The product employs a special LED as the light source for measurement that was developed specially by Epitex Incorporation, a member of the Ushio Group that specializes in the manufacture of LEDs. In addition, Ushio’s optical technologies have enabled the irradiation of highly stable, high-intensity beams to a 0.6-mm light path. The precision alignment technology for optical devices has made it possible to create a device that enables alignment to within tens of micrometers, even after centrifuging the sample at 3000 rotations per minute.

The measurement chip was developed thanks to the application of ROHM’s microfabrication technologies cultivated through the development of semiconductors and LSIs. The design and processing technologies for minute fluid circuits having a minimum width of 100 μm have enabled the integration of all processes, from blood cell separation, measurement and test agent mixing to drainage, into a chip that is several centimeters square. This makes it possible to conduct the tests with a greatly reduced quantity of blood.

SKK is the sole distributor in Japan of qualitative reagents that permit the quick examinations of CRP with whole blood specimens. The company's familiarity with the clinical significance of CRP measurement has permitted the effective utilization of its expertise for commercialization that is suitable for the needs of medical professionals (safety, speed and ease), resulting in the development and commercialization of the testing system. Having the largest share of the market for blood glucose self-measurement systems, the company has provided expertise for the immediate, high-precision measurement of hemoglobin A1c (a marker for blood glucose control) in microvolume blood.

Measurement wavelength	635 nm, LED with optical feedback function
Data memory	Saves the latest measurement results for 100 specimens
Outer dimensions and weight	Approximately, 340 (W) x 290 (D) x 270 (H) mm. and approximately, 9.5 kg (main body only)
Recommended retail price	\1,560,000 (including tax)
Manufacturer and distributor	Ushio
Distributor	Sanwa Kagaku
Notification number	28B2X10008000001

Product name	Banalyst Ace CRP (for normal concentrations)	Banalyst Ace hsCRP (for low concentrations)	Banalyst Ace Hb A1c
Time for measurement	7 min. 30 sec.	7 min. 30 sec.	9 min. 30 sec.
Type of specimen	Whole blood/plasma/serum	Whole blood/plasma/serum	Whole blood
Quantity of specimen	4μL	8μL	5μL
Measurement method	Latex immune nephelometry	Latex immune nephelometry	Latex immune nephelometry
Within-run reproducibility	CV = 5% (concentration: 1.0 mg/dl)	CV = 3% (concentration: 0.1 mg/dl)	CV = 0.8% (concentration: 4.8%)
Degradation ability			± 0.08% (concentration: 4.8%)
Range of measurement	0.1mg/dL to 20mg/dl	0.01mg/dl to 4.0mg/dl	3.0% to 13.0%
Each package used for	50 tests	10 tests	10 tests
Suggested retail price	￥8,400 (including tax)	￥3,780 (including tax)	￥5,250 (including tax)
Manufacturer and distributor	SKK	SKK	SKK
Manufacturer	ROHM	ROHM	ROHM

2003: ROHM announces the outcome of the joint development of a biochip for more advanced healthcare under the collaboration of Prof. Yasuhiro Horiike from the National Institute for Materials Science.

2003: ROHM and SKK commence research into the practical application of a measurement chip for use in clinical laboratory tests, including painless blood collection procedures.

2004: Ushio, ROHM and SKK commence joint development of a microvolume blood testing system based on the μTAS technology (measurement chip and analyzer).

2004: Ushio, ROHM and SKK conclude agreement on joint research for commercialization of a CRP measurement system based on the measurement chip.

2008: Ushio, ROHM and SKK successfully commercialize a microvolume blood testing system based on the μTAS technology.

*1: Abbreviation of Micro Total Analysis System. This system permits efficient and quick performance of a series of chemical manipulations through the buildup of varied liquid devices on a chip that is several millimeters to several centimeters square.

*2: Untreated blood that is collected. Blood consists of blood cells comprising erythrocytes, leucocytes and platelets; and plasma components including proteins, vitamins, minerals and waste matter.

*3: The specified medical check/health-related guide system commenced in April 2008 for those aged at least 40 with medical insurance. Metabolic syndromes (visceral fat obesity) refer to the condition in which a person satisfies at least two risk factors among hyperglycemia, hyperlipemia and hypertension provided he or she is obese. The new health check system for metabolic syndromes aims at detecting people with metabolic syndromes and borderline conditions to prevent the onset and exacerbation of lifestyle-related diseases.

*4: Abbreviation of Point of Care Testing. Diagnostic testing at or near the site of patient care, such as clinics, waiting rooms at hospitals, bedside and patients’ home. POCT is expected to contribute to the improved quality of healthcare, permitting immediate judgment of test results, and quick and appropriate treatment.

The product will be presented at the following academic and exhibitory meetings.

October 9 to 11:
The 40th General Meeting of the Japan Society for Clinical Laboratory Automation (Pacifico Yokohama, Yokohama)
* Presentation and showcase of the product

October 31 to November 1:
Japan Society for Premature and Newborn Medicine (53) (Sapporo Convention Center, Sapporo)
*Showcase of the product

November 15 and 16:
The 40th Annual Meeting of the Japanese Society for Pediatric Infectious Diseases (Nagoya Trade & Industry Center, Nagoya)
*Showcase of the product

Ushio Inc. (president and CEO: Shiro Sugata) was established in 1964. The company handles a variety of lighting equipment, halogen lamps for OA, UV lamps for exposure used in the semiconductor/liquid crystal manufacturing process, high-brightness discharge lamps for data projectors and xenon lamps for movie projectors. They also enjoy a strong market share with many of their products, manufacturing and distributing various optical devices and movie projectors that incorporate their in-house lamps. The head office is located in Chiyoda Ward in Tokyo. The consolidated sales for the term ended March 2008 were 148,100,000,000 yen, and there are 4681 employees. 
http://www.ushio.co.jp

ROHM Co., Ltd. (president & CEO: Ken Sato) was founded in 1958. The company offers system solutions across a wide range of market fields, such as home appliances, mobile phones, communications equipment and automobile equipment. They provide customers with LSIs and discrete semiconductor products that feature a high level of quality and reliability through their global development and marketing networks. The head office is located in the city of Kyoto. The consolidated sales for the term ended March 2008 were 373,400,000,000 yen, and there are 20,539 employees.
http://www.rohm.co.jp

Sanwa Kagaku Kenkyusho Co., Ltd. (president & CEO: Kazuo Yamamoto) was established in 1953. A subsidiary of Suzuken Co., Ltd., a pharmaceutical distributor. With the aim of becoming an outstanding partner for the treatment of diabetes, the company is engaged in R&D as well as the manufacture and distribution of ethical drugs, diagnostic agents, nutrients and health foods, concentrating its management resources in the fields of diabetes and its complications. The head office is located in Nagoya in Aichi Prefecture. The consolidated sales for the term ended March 2008 were 54,400,000,000 yen, and the number of employees is 1292.
http://www.skk-net.com/

○Analyzers：
USHIO INC.
IR & Public Relations
Tel: +81-3-3242-1815 / Fax: +81-3-3245-0589
Please use the online inquiry form on our website.

○Measurement chips：
ROHM Co., Ltd.
PR & IR Office
TEL+81-75-311-2121　

○Distribution：
Sanwa Kagaku Kenkyusho Co., Ltd.
PR Office, General Affairs Department
TEL+81-3-3232-2601