A Diagnostics & Imaging Week

Proteome Systems (Sydney, Australia) reported an "early outcome" from its collaboration with the HighQ Foundation (New York) in identifying multiple biomarkers for Huntington's disease (HD) using its Proteom discovery platforms.

It said that a two-year human study would now validate these markers which could then be used to accelerate the development of new drug treatments for HD and other neurodegenerative diseases, such as Alzheimer's and Parkinson's.

In the program, funded by the HighQ, Proteome said it discovered the proteins for HD using its ProteomIQ and BioinformatIQ platforms. These proteins found in human blood samples constitute potential biomarkers for detecting HD onset and progression.

In parallel with the HD biomarker validation program, Proteome will analyze blood samples collected from people with Parkinson's and Alzheimer's to investigate which of these biomarkers are useful to determine efficacy of drugs being developed; monitor progression of these diseases to administer the most effective drugs; and screen people for early disease onset.

Dr. Allan Tobin, scientific advisor to HighQ, said, "The identification of biomarkers that can be used to monitor the pathological changes that occur during HD is essential for the development of effective drug treatments."

Currently, there are no drugs available to treat HD, and rapid drug development requires diagnostic biomarkers to determine drug efficacy.

Proteome and HighQ said they are considering patenting several of these proteins as candidate biomarkers of the onset and progression of neurodegenerative diseases, including HD.

HD is caused by a defect in the Huntington gene that genetically programs degeneration of neurons in certain areas of the brain, causing uncontrolled movements, loss of intellectual faculties and emotional disturbance. In the U.S., about 30,000 people have HD; estimates of its prevalence are about one in every 10,000 persons globally.

Those with the defective gene will develop this fatal disease usually between age 30 and 50. The disease can be diagnosed with a DNA test at birth, but only about 5% of suspected cases in the U.S. are diagnosed early because there is currently no way of determining when the disease will manifest, and no treatment is available.

Proteome offers diagnostics and therapeutics expertise in the fields of respiratory disease, neurobiology and ageing, cancer and infectious diseases.

Two get CE mark, one cites China progress

Several diagnostics firms have reported recent international actions on product approval applications.

Tm Bioscience (Toronto), a developer of genetic tests, reported that its Tag-It Cystic Fibrosis (CF) Kit has won the CE mark.

The Tag-It CF Kit is used to simultaneously detect and identify mutations and variants in the CF transmembrane conductance regulator (TR) gene in human blood or blood spot specimens in order to determine CF-carrier status in adults, as an aid in newborn screening, and in confirmatory testing in newborns and children. Tm said that performance testing has established that the Tag-It CF Kit is 100% accurate and greater than 99.9% reproducible and precise.

The kit is also the first multiplexed human disease genotyping test to be cleared by the FDA as an in vitro diagnostic device, Tm said.

"Having the CE mark on our Tag-It CF test expands our reach into the European market for CF testing and further asserts our leadership position in the clinical genetic testing market," said Greg Hines, president and CEO.

"A proven, highly accurate and affordable cystic fibrosis molecular test is needed for the European market for carrier screening and as a tool for diagnosis of newborns," said Dr. Jeremy Bridge-Cook, vice president, marketing and business development.

CeMines (Golden, Colorado) reported that its wholly owned CeMines International subsidiary, CeMines Estonia OU (Tallinn, Estonia), received notice that the company was granted CE-marking for its CellCorrect LAb Detection Kit for clinical use. The kit is a minimally invasive molecular blood test to aid in diagnosing lung cancer. It will be marketed and distributed in the EU under the brand name CellCorrect KvA-40 LAb Kit.

Roger Attick, president and CEO of CeMines, called the clearance the company's "most significant accomplishment to date. We believe that our integration of the CellCorrect diagnostic array protocol and CeMines' Molecular FingerPrinting bioinformatics applications will eventually establish the CellCorrect product family as the most cost-effective and operationally efficient DX modality available today."

CeMines last May reported filing an FDA 510(k) application to clear CellCorrect Lab for clinical use. CeMines said it has had "productive discussions with the FDA" and expects "substantial forward progress later in 2006."

CeMines, founded in 2000, specializes in cell biology and regulatory network research and development that is principal to commercialization of novel clinical products for worldwide use in diagnosis and possible treatment of cancer.

• Calypte Biomedical (Lake Oswego, Oregon) re-ported receiving notification from the Beijing Drug Administration that its application for approval in China of its Aware OMT (Oral) HIV-1/2 rapid test has been accepted.

Roger Gale, CEO and chairman of Calypte termed China "one of the countries that may experience a significant spread of HIV unless the government can follow through on its plans to curtail the growth of this problem. China has an acknowledged testing gap and has officially announced plans to offer voluntary HIV testing to its entire 1.36 billion population."

Scottish screening program extends Cytyc pact

Cytyc (Marlborough, Massachusetts) said the Scottish Cervical Screening Program has extended the current national contract with Cytyc UK for the supply of Cytyc's ThinPrep Pap Test to all Scottish laboratories.

The exclusive contract is for an additional five years, which is estimated to represent 2.2 million ThinPrep Pap Test sales during that period.

Cytyc said the decision follows the successful national conversion from conventional pap smears to the ThinPrep Pap Test in Scotland begun in 2003.

It said that since implementation of the ThinPrep System, the Scottish Cervical Screening Program has noted a range of clinical benefits related to the product, including a reduction in the number of patient recalls due to unsatisfactory specimens and a steady reduction in turnaround time for reporting results. Each year more than 440,000 women participate in the Scottish Cervical Screening Program and 11 laboratories are responsible for processing the tests.

"We have been very impressed with the clinical efficacy of the ThinPrep technology as well as the robust sample identification and simplified processing afforded by this technology," said Dr. Jocelyn Imrie, consultant cytopathologist and quality assurance adviser for Scotland.

Cytyc products cover a range of women's health applications, including cervical cancer screening, breast cancer risk assessment, treatment of excessive menstrual bleeding and treatment of breast cancer.

Immunicon in pact with Kreatech

Immunicon (Huntingdon Valley, Pennsylvania) reported entering into a supply and marketing license agreement with Kreatech Biotechnology (Amsterdam, the Netherlands) for use of Kreatech's Universal Linkage System (ULS) system with its technologies.

The agreement follows Immunicon's completion of evaluation by Immunicon of ULS-labeled centromere probes for detection of abnormalities common to cancer cells.

Immunicon said it plans to develop assays for use in confirming whether certain cells of epithelial origin in a sample of a patient's blood are cancerous.

Leon Terstappen, Immunicon's senior vice president of research and development and chief scientific officer, said, "This represents an important technology advance for Immunicon because we have demonstrated that cells in patient blood samples can be subjected to molecular analysis after they have been processed on Immunicon's technologies. Samples that contain as few as one circulating tumor cell can now be analyzed for the presence or absence of chromosomal abnormalities and for experiments involving gene amplification."

"Furthermore, the ability to assess amplification of specific genes in cancer cells may allow us to identify and determine the presence or absence of specific therapeutic targets."

Immunicon is a developer of cell- and molecular-based human diagnostic and life science research products.

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