FDA grants clearance of market, sale of new allergy-friendly latex condom
WILMINGTON, Del. Vystar and Alatech Healthcare on Friday announced that the Food and Drug Administration granted 510(k) clearance to market and sell Alatech’s Envy condom manufactured with Vytex Natural Rubber Latex.
The Envy condom will be the first consumer medical product available in the U.S. made from Vystar’s patented Vytex NRL, which has less than 2 micrograms/dm2, virtually undetectable levels, of the antigenic proteins that can cause an allergic response, while retaining and improving upon all the desirable qualities of latex.
The Envy condom will carry labeling that will reflect the lowest antigenic protein content currently available in a natural rubber latex medical device in the U.S. Natural rubber latex contains more than 200 proteins, similar to other natural plant materials, of which 13 are known allergens. The Vytex NRL process was created to significantly reduce these known proteins. Vystar’s business model is to assist all manufacturers in marketing the Vytex component of their products.
Alatech will market and sell the Envy NRL condom to retailers and through other distribution channels, and expects the product to be available to consumers in the coming months.
CDC confirms 896 swine flu cases
ATLANTA The number of confirmed H1N1 cases in the United States climbed to 896 cases, with two deaths, the Centers for Disease Control and Prevention announced Thursday morning.
“The ongoing outbreak of novel influenza A (H1N1) continues to expand in the United States,” the agency stated. “CDC expects that more cases, more hospitalizations and more deaths from this outbreak will occur over the coming days and weeks.”
CDC has issued guidance for health care providers on the use of antiviral medications during the current outbreak. The priority use for influenza antiviral drugs is to treat severe influenza illness and people who are at high risk of serious influenza-related conditions.
And CDC has developed a PCR diagnostic test kit to detect this novel H1N1 virus and has now distributed test kits to all states in the U.S. and Puerto Rico. This increase in testing capacity is likely to result in an increase in the number of reported confirmed cases in this country, which should provide a more accurate picture of the burden of disease in the United States.
Diatherix Laboratories releases first clinically available swine flu test
HUNTSVILLE, Ala. Diatherix Laboratories on Thursday released the first clinically available test that can definitively diagnose the current strain of H1N1 virus, also known as the swine flu, in six hours or less. The test is now commercially available to hospitals, private physician practices and public health departments for the rapid confirmation of suspected H1N1 patients.
Until now, it took several days to confirm a suspected H1N1 patient due to the numerous rounds of testing needed to make a definitive diagnosis, the company stated.
“Due to the highly mutative nature of the H1N1 strains, it can be very difficult to diagnose the H1N1 virus with many of the current testing methods,” stated Jian Han, laboratory director at Diatherix and faculty investigator of the HudsonAlpha Institute for Biotechnology. “Because our Tem-PCR technology can test for multiple genetic targets at one time, it is the only rapid molecular test that, from a nasal swab, can detect and differentiate multiple influenza strains and nine other respiratory viruses in a single test. This advanced technology provides physicians an accurate and definitive diagnosis.”
“Since the Diatherix test allows physicians to quickly differentiate H1N1 patients from those who have similar symptoms, infected patients can be provided proper antiviral therapy in a timely manner,” commented Dennis Grimaud, Diatherix CEO. “For example, if in 24 hours or less we could verify a suspected student was not infected with the H1N1 virus, this could prevent a school district from closing.”