Roche Diagnostics, a World Leader in HIV Monitoring Tests, and ARK Diagnostics, Inc. Sign Letter of Intent to Commercialize ARK's HIV Drug Monitoring Products Business Wire
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Roche Diagnostics, a World Leader in HIV Monitoring Tests, and ARK Diagnostics, Inc. Sign Letter of Intent to Commercialize ARK's HIV Drug Monitoring Products

Business Wire - December 6, 2007


SUNNYVALE, Calif.--(BUSINESS WIRE)--ARK Diagnostics, Inc. ("ARK"), and Roche Diagnostics signed a letter of intent to negotiate a collaboration agreement that would grant Roche distribution and commercialization rights for ARK's anti-HIV drug monitoring products.

"We are pleased to partner with Roche Diagnostics - a world leader in diagnostics - to leverage its distribution and marketing strengths to quickly get the anti-HIV drug monitoring products to market," said Johnny Valdez, president of ARK Diagnostics. "Roche will be immediately selling and distributing our products worldwide."

The Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) impacts 1.2 million people in the U.S. alone and more than 40,000 people become newly infected each year. The treatment for HIV infection consists of combination therapy of three or more drugs which work against HIV infection itself by slowing down the replication of HIV in the body. The potential world-wide market for HIV drug monitoring products is estimated at $100-150 million annually.

"This agreement is an example of our commitment and strategic relationship with ARK Diagnostics, Inc. and an important step in our efforts in improving the quality of health care for HIV-infected patients," said Oliver Strobel, director of business development at Roche Applied Science, a division of Roche Diagnostics.

ARK's products are immunoassay reagents for certain classes of anti-HIV drugs such as protease inhibitors and nonnucleoside reverse transcriptase inhibitors used to suppress viral replication. The immunoassay reagents are compatible with most automated clinical chemistry analyzers and measure a patient's blood level of anti-HIV drug, helping doctors to determine if adequate drug exposure has been achieved at a given dose.

"Monitoring tests for viral load and cell markers have contributed significantly to improving the lives of those infected with HIV; the added benefit of measuring drug level is thought to enhance therapy by assuring patients achieve the effective circulating concentration of drug with the dosage used," Valdez said. "We look forward to continuing to develop our TDM product portfolio to help those with HIV and other diseases who may benefit from continuous monitoring."

About ARK Diagnostics, Inc.

ARK is a scientific leader in pioneering the development of new in vitro diagnostic immunoassay reagents for therapeutic drug monitoring. This includes the development of innovative homogeneous immunoassay reagents for quantifying antiretrovirals used as part of highly active antiretroviral therapy (HAART) for the treatment of human immunodeficiency virus (HIV) type 1. Helping healthcare professionals to better monitor and manage treatment is an increasingly important challenge in modern healthcare. The company's TDM reagents are designed to enable individualized therapy and address unmet clinical needs. High-quality, convenient, and cost-effective reagents enable routine use of TDM in clinical practice and research settings. The company's innovative TDM reagents are designed to serve healthcare institutions, researchers, and clinical laboratories. Founded in 2003, ARK Diagnostics, Inc. is located in Sunnyvale, CA. Additional information about ARK is available at www.ark-tdm.com.

Contacts

ARK Diagnostics, Inc. | Ken C. Kasper, Ph.D, 408-747-0708 | Director Quality Assurance and Compliance | ken@ark-tdm.com


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