A blood test for cancer and other industry highlights

Veridex pushes for a blood test that detects cancer cells, while Janssen brings the first antipsychotic treatment for schizoaffective disorder to Europe and Celera files for FDA approval of a new diagnostic test for heart disease.
Written by Janet Fang, Contributor

Johnson & Johnson and Celera announce new treatments, collaborations and applications for regulatory approval.

1. Blood test for cancer

Veridex, a Johnson & Johnson company, announced its collaboration with Massachusetts General Hospital (MGH) to develop and commercialize a next-generation circulating tumor cell technology for capturing, counting and characterizing tumor cells found in patients’ blood.

Healthday News explains: the microchip is dotted with tens of thousands of tiny posts covered with antibodies designed to stick to tumor cells. As blood passes over the chip, tumor cells separate from the pack and adhere to the posts.

The test has already been used experimentally in about 200 patients.

“If the technology gets more and more sensitive, we may be able to use this as an early diagnostic,’’ says Daniel Haber, director of the MGH Cancer Center. “You might be able to pick up any tumor which invades into the blood system, and that could mean there is a chance of catching tumors before they spread.’’

Haber says it’s roughly a $30 million deal.

2. The EU’s first antipsychotic treatment for schizoaffective disorder

Janssen Pharmaceutical Companies of Johnson & Johnson announced its European Commission approval for INVEGA (paliperidone ER) – which treats psychotic or manic symptoms of schizoaffective disorder.

The disorder is part of the schizophrenic spectrum, and it’s characterized by both symptoms of schizophrenia and a major mood disorder, such as bipolar disorder or depression.

"We are proud to be able to bring to market the first antipsychotic treatment for schizoaffective disorder in Europe – a difficult to diagnose condition associated with a high rate of hospitalizations and suicidal behavior,” says Christophe Tessier of Janssen.

3. New diagnostic test for heart disease

Celera announced that it has submitted a premarket approval application (PMA) to the Food and Drug Administration (FDA) for its KIF6 Genotyping Assay – a new molecular diagnostic test to detect a marker for risk of coronary heart disease.

A PMA is, in effect, a private license granted to the applicant for marketing a particular medical device.

This in vitro test can aid clinical evaluation when statin treatment is being considered. Statins are drugs used to lower cholesterol levels by blocking an enzyme that helps produce cholesterol in the liver.

"We’re pleased to have filed for regulatory approval on our KIF6 Genotyping Assay," says Kathy Ordoñez, Chief Executive Officer of Celera. "This test has been designed to contribute to the prediction of risk for coronary heart disease and response to statin therapy.”

Image: blood spatter by Heo2035 via Flickr

This post was originally published on Smartplanet.com

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