Keeping you up to date on recent headlines in diagnostics.

Vitro Diagnostics moves forward on adult stem cell products ... Vitro Diagnostics (Golden, Colorado) reported advances in its adult stem cell products and technology with application to cell-based therapy of cancer. Cancer stem cells are thought to generate cancerous tumors, and while some of these tumor cells are destroyed by chemotherapy and radiation, cancer stem cells resist these treatments causing recurrences and metastasis of cancer following standard therapy. For example, glioblastoma tumors underlying Senator Kennedy`s brain cancer may arise from cancer stem cells that resist conventional treatments. Additional research shows that certain adult stem cells migrate to cancer stem cells and may be used to carry toxic agents to selectively eradicate cancer stem cells thereby providing novel cellular therapy specifically targeted to cancer-causing cells. Further development of Vitro`s stem cell therapy may allow treatment of presently untreatable cancer and also have more widespread applications to prevention and treatment of cancer. Vitro`s proprietary stem cell technology and products, now subject to pending patent protection, may lead to novel cell therapy for cancer. The company is pursuing suitable strategic partners to commercialize these novel therapeutic products. Furthermore, the company has also commercialized various modified stem cell lines and related products to support cancer stem cell research including the development of new methods to target the selective eradication of cancer stem cells, which is essential to therapeutic efficacy. These products and other tools for use in stem cell research are now commercially available ( The hedgehog pathway drives the proliferation of cancer stem cells and has been a target for drug development for sometime, based on earlier work with the plant-derived substance, cyclopamine, a specific blocking agent of the hedge hog pathway. Novel hedge hog drugs have been developed by several pharmaceutical companies and new reports are showing effectiveness in treating cancer. Hedgehog blocking drugs are known to kill cancer stem cells and this mechanism may underlie their effectiveness in cancer treatment. Vitro's novel stem cell mediated cancer therapy complements hedgehog drugs by targeted destruction of cancer stem cells.

MDDX sets up shop on Prince Edward Island ... A new company focused on providing links between remote heart patients and their doctors is opening a service center on Prince Edward Island. "The Government of Prince Edward Island is pleased to welcome MDDx (Medical Devices & Diagnostics; Prince Edward Island) to the island business community," Premier Robert Ghiz said. "This innovative company complements our government's innovation and economic development strategy, Island Prosperity: A Focus for Change. MDDx also strengthens the development of the e-Health Centre of Excellence at the Holman Building in downtown Summerside." MDDx uses wireless monitoring technology to provide real-time remote medical diagnostic monitoring and reporting services between cardiovascular patients and their healthcare providers. The company, created by Pearl Capital Group (New York), is expected to employ up to 20 people in Summerside within two years. The investment is in line with Canada's Industrial and Regional Benefits policy and has been credited to Boeing's reinvestment plan associated with the acquisition of four C-17 Globemaster III multimission transport aircraft delivered to the Canadian Forces. "Boeing is dedicated to delivering on the promises it makes to invest in the regions where we do business, as this investment in MDDx demonstrates," said Gwen Kopsie, director of International Industrial Participation and Alliances for Boeing Integrated Defense Systems. "We are committed to creating partnerships that result in long-term, high-value jobs for Canadians." "We are pleased to see world leaders such as Boeing and Pearl Capital Group select Prince Edward Island as a location to do business," said Allan Campbell, Minister of Innovation and Advanced Learning. "The Island's labour force continues to be an attractive selling feature when recruiting new companies to the province. MDDx will create highly-skilled, well-paying jobs for Islanders." The Province of Prince Edward Island is supporting MDDx with a labour rebate agreement of up to $500,000 for the first 20 positions created. Government is also investing in a $100,000 strategic infrastructure rebate for the purchase of equipment and technical infrastructure. Canada's Industrial and Regional Benefits policy requires companies receiving federal defense and security contracts to invest in the Canadian economy at a value equal to the contract. These investments encourage industrial development and produce significant economy activity in Canada.

Almac, Lilly UK in pact to develop biomarker for tumor response to treatments ... Almac (London) and Lilly UK have entered into a partnership to develop a companion diagnostic for Alimta, with cisplatin, as a combination therapy for non-squamous non-small cell lung cancer. The study focuses on evaluating the ability of using an enzyme compound (Thymidylate Synthase) as a marker that might be used to predict whether a patient's tumor will respond to Alimta in combination with cisplatin. In addition, a number of other analyses will be conducted to identify other potentially useful biomarkers that might accurately tell physicians which patients are most likely to benefit from the combination therapy. Paul Harkin, president of Almac Diagnostics, explains that the company's objective is to develop such biomarkers to help physicians tailor treatments to individual patients. "Almac is focused on enabling personalized medicine," Harkin said in a prepared statement. "Our core expertise is in the discovery and validation of both prognostic and predictive biomarkers. We have a specific expertise in the development of biomarkers from FFPE tissue and are very happy to announce this partnership with Lilly." FFPE stands for formalin-fixed, paraffin-embedded tissue, and refers to very thin-sliced sections of tissue that is preserved for use in research. In this case they use tissue samples of non-squamous non-small cell lung cancer. The project will involve a multi-center, early stage study that will recruit patients diagnosed at stage IIIB/IV non-small cell lung cancer. Almac's technical team will perform a variety of genetic tests on tumor tissue samples and analyze the data to identify individual and combinations of markers that will select patients likely to benefit from treatment with Alimta.

Hypertension Diagnostics tech used in START clinical study ... Hypertension Diagnostics (St. Paul, Minnesotta) reported that its HDI/PulseWave (CR-2000) has been selected for use in the Strategic Timing of AntiRetroviral Treatment (START) substudy on Arterial Elasticity that will examine blood vessel function and cardiovascular risk during HIV infection. START is a randomized, international multicenter trial that is examining the early initiation of antiretroviral therapy (ART) in HIV-infected individuals in approximately 88 sites in 22 countries. START is funded primarily by the National Institute of Allergy and Infectious Diseases and the National Heart, Lung, and Blood Institute, both part of the National Institutes of Health, through a grant awarded to the University of Minnesota (Mineapolis) and is being conducted by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). The START Arterial Elasticity sub study is a novel study designed to determine if early initiation of ART is superior to deferral of ART in increasing arterial elasticity and, thereby, preventing cardiovascular disease. Measurement of arterial elasticity using the CR-2000 will be used to study blood vessel function and cardiovascular disease risk during HIV infection. The substudy will enroll approximately 300 patients over three years at 16 sites located in the U.S. and six other countries around the world. Patients will be followed for a period of four and one-half years. Greg Guettler, president of HDI, said, "There are over 500,000 people in the U.S. in active treatment for AIDS. Over the last several years, cardiovascular disease has become more common in people with HIV infection and it now ranks as a major cause of death with the risk for heart attack 70 to 80% higher among people with HIV than among those who do not have HIV. We are, therefore, very proud to have been selected to play a key role in the START substudy designed to determine whether arterial elasticity measurements can provide additional insight into the prevention of cardiovascular disease in HIV patients. The selection of our technology in this ground breaking trial shows the importance of measuring arterial elasticity in detecting and managing cardiovascular disease and is a further demonstration of HDI's mission to become the standard for identifying and monitoring patients with cardiovascular disease."

— Compiled by Omar Ford, MDD