Abbott Laboratories announced a collaboration and license agreement with Wyeth to develop an automated blood test to monitor therapeutic levels of the anti-rejection drug Rapamune (sirolimus).

Under the agreement, Abbott and Wyeth will jointly develop a sirolimus test for use on Abbott's IMx and other automated immunoassay systems. Abbott's automated diagnostic analyzers are widely used in hospital laboratories throughout the world. Following appropriate regulatory clearances, Abbott's manufacturing partner Axis-Shield, based in Dundee, Scotland, will manufacture the test and Abbott will distribute it worldwide.

"Our agreement with Wyeth builds upon our leadership position in transplant diagnostics and reinforces our commitment to improve the medical outcome for patients who have undergone kidney transplants," said William Brown, PhD, vice president, diagnostic assays and systems development, Abbott Laboratories.

In addition to the sirolimus test, which Abbott hopes to be available in late 2004, the company also provides tests to monitor the immunosuppressant drugs cyclosporine and tacrolimus.

To help reduce the risk of organ rejection, transplant patients are given a lifelong regimen of immunosuppressant agents. These drugs are intended to lower the body's normal immune response, allowing the transplanted organ to remain functional.

Rapamune is recommended for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with cyclosporine microemulsion and corticosteroids for 2 to 3 months. In patients at low to moderate immunologic risk, cyclosporine should be withdrawn 2 to 4 months after transplantation and Rapamune dose should be increased to reach recommended blood concentrations.

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use Rapamune. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.