LONDON - Provalis plc received U.S. 510(k) regulatory approval for its doctor's office diabetes monitoring product, Glycosal, a move expected to improve patient care and push the company through to profitability.

The test measures glycated hemoglobin in a 4-minute test, a procedure that currently can only be carried out in laboratories. One million tests per year are conducted worldwide at a cost of US$800 million per annum.

CEO Phil Gould told BioWorld International, "This is a tremendously important development for the long-term care of diabetics, and will be a major driver for revenue. It will provide us with the resources to take the whole company forward."

Provalis changed its name from Cortecs plc in 1999, after Gould took over as head following the exit of founding CEO Glyn Travers. The size of the company was cut, and offices in London, the U.S. and Australia were closed. Gould decided to concentrate on moving the Medical Diagnostics and Healthcare divisions into profitability, and much of the discovery and development activity was "parked" until it could be funded from turnover.

"The launch of Glycosal in the U.S. should release money for our therapeutic research division," Gould said. "As and when we have the funds, we will look at how to speed projects up. I would hope to have products in clinical trials within the next two years."

Cortecs was founded as a drug delivery company, but two of its main products, an oral formulation of salmon calcitonin for the treatment of osteoporosis, and an oral formulation of insulin, failed in clinical trials. Under Gould, the focus has shifted to vaccines, and Provalis, based in Deeside, has a number of vaccine candidates for the treatment of infectious diseases in preclinical research.

Glycosal, already on the market in Europe, will be distributed in the U.S. by Bio-Rad Laboratories Inc. and Drew Scientific Group plc.

Tighter control of diabetes reduces the risk of debilitating long-term complications, including blindness, ulcers, cardiovascular disease and increased risk of stroke. Glycosal measures the average level of glucose over the last three months by measuring HbA1c, a fraction of hemoglobin, aiding in monitoring the progression of the disease and the effectiveness of therapy. Provalis said that a 1 percent reduction in HbA1c levels reduced the long-term side effects of diabetes by 25 percent.

The first sales of the product were to a doctor in the Hebrides Islands off the coast of Scotland. "He said that getting results back from the laboratory took three weeks, and by that time the patient was likely to be back on the trawler [at sea] again," noted Gould. The ease of carrying out the test is expected to enlarge the market.

Provalis is now developing a consumer version of the test, allowing patients to monitor the disease themselves.

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