Zonda to begin trials of rapid point-of-care test for Chlamydia
MURRIETA, Calif. CLX Investment announced that Safis Solutions is preparing to begin clinical trials for Zonda’s test for Chlamydia, in an effort to achieve clearance from the Food and Drug Administration for the product. CLX has controlling ownership of Zonda.
Safis has been sought as a sub-contractor of American Health Partners who had been engaged by CLX to assist with the launching of medical diagnostic testing products for CLX’s subsidiaries. As part of preparation for the trials, Safis has sent out bid requests to several contract research organizations to conduct the studies for Zonda.
Safis has begun work on the testing protocol and will submit it to the FDA before testing begins. Safis has developed estimates on the number of expected clinical sites and the anticipated timeframe necessary to gather data. Once the clinical data is completed, the data will be analyzed and Safis Solutions will prepare and submit documents for FDA clearance, which will allow for its sale in the United States.
In 2006, 1,030,911 chlamydial infections were reported to Centers for Disease Control from 50 states and the District of Columbia. This is the first time in history that reported cases of Chlamydia in the U.S. have exceeded 1 million. Zonda’s rapid point-of-care test will be the first of its kind for the STD.
LG debuts home health-monitoring in a cell phone
CALGARY, Canada The Home Health Monitoring Solution is a new handheld device developed by LG Electronics allows patients with chronic illnesses to send such information as their pulse, blood pressure and glucose levels to their physician wirelessly, according to published reports.
The goal is eventually to add the technology to cellphones, the same way photography and music capabilities have been added. The product is designed to help patients with illnesses that need constant monitoring. It could also be useful for seniors with limited mobility and for patients who live in rural areas. By constantly keeping track of someone’s medical data it would provide a greater help to the patient and physician monitoring the illness.
The first stage of tests for the three-year project will begin next month. It will involve monitoring blood pressure, pulse and temperature. Down the road, glucose levels and other blood chemistry markers will be added as features.
Senate votes to extend current SCHIP legislation through March 2009
WASHINGTON The Senate on Tuesday approved a bill unanimously that will extend the State Children’s Health Insurance Program through March 2009, according to reports. The House of Representatives plans to look at the issue before the end of the year.
This extension will end a battle for now with President Bush, who had twice vetoed the bill, including the most recent veto last week. Bush vetoed the program the second time because he felt the second version was too similar to the first and would cost too much money as well as shift children from the private marketplace to government run programs.
The bill also would stop a scheduled 10 percent pay cut for Medicare doctors for six months and provide a 0.5 percent increase instead. The health legislation costs about $6 billion, but was paid for by savings in other health programs.
The program currently covers about 6.6 million poor children.