Roche, OraSure accept FDA 510(k) hole for Oral Ichor Sedate Testing Group

OraSure Technologies, Inc. (Nasdaq:OSUR) and Roche announced today that the U.S. Chow and Hallucinogenic Regulation (FDA) has granted the Companies 510(k) clearance on four identical fully automated oral fluid drugs of vituperation assays developed to be inured to exclusively as part of OraSure's Impede® Pronounced Unformed Dope Testing System. The cleared verbal watery assays count Phencyclidine (PCP), Cocaine, Opiates and Methamphetamine.

The spoken mutable assays practise Roche's KIMS (kinetic interaction of micro-particles in solution) technology and were jointly developed covered by an compact previously signed via the parties. These assays are designed to run on various clinical chemistry automated analyzers, which are intended to countenance vocal fluid samples to be processed with the selfsame efficiency as current fully automated urine-based drug tests.

We are acutely tickled pink to announce this valuable milestone in our honky-tonk stab with Roch e to improve and call these important drugs of vilify assays, said Douglas A. Michels, President and CEO of OraSure Technologies. The blend of Roche's commerce leadership in lab instrumentation and reagent chemistry and our operation in Order Risnia oral fluid technology and sample collection devices has enabled us to cause to market a breakthrough structure that inclination own an next and total contact on laboratory proficiency seeking drugs of abuse testing.

The confirmation of this in front fasten on of fully automated pronounced running drugs of abuse assays demonstrates the strengths and familiarity of both companies, said Unconstrained G. Sieben, SVP and Time D Director of Roche Expert Diagnostics. Specifically the technologies and expertise of our collective research and advance teams will enable us to stock up novel high-priced throughput verbal running soporific testing solutions.

The Companies anticipate the key four assays to be available for traffic later this year. A variety of additional assays are also in condition and are currently in varying stages of submission with the FDA.

Developed and manufactured through OraSure Technologies, the Intercept® Treatment Testing Process is the single FDA-cleared in vitro diagnostic laboratory-based said pliant testing system second-hand an eye to detecting commonly maltreated drugs such as marijuana, cocaine, opiates, PCP and amphetamines (including methamphetamine and ecstasy) and an eye to detecting barbiturates, methadone and benzodiazepines. All of these drugs of rail against assays are currently processed in laboratories using microplate technology. In collaboration with Roche, four of these assays â€" PCP, cocaine, opiates and methamphetamine â€" can instantly be processed efficiently using automated analyzers. Intercept® is predominantly tempered to in workplace, tranquillizer treatment and criminal punishment testin g markets, as admirably as in community kind systems.

A worldwide chairman in diagnostics, Roche has been providing testing solutions as a remedy for the drugs of malign call for more than 25 years. Roche offers a unshaded check-up menu, integrated analyzer platforms and automation solutions to stop a substantial variety of labs increase receipts, repair efficiency and lift tolerant care.

Useful outcomes from Argos AGS-004 Form 2a trial in patients with HIV

Argos Therapeutics announced today that its Arcelis immunotherapy since the treatment of HIV, AGS-004, demonstrated favourable outcomes with the essential endpoint of viral albatross hold back and a favorable safety and immunogenicity analysis in a decisive review of a Aspect 2a clinical trial. Data payment AGS-004 were presented in a flier at the 18th Colloquy on Retroviruses and Selfish Infections (CROI) in Boston.

In the mug up, AGS-004 was safe and well tolerated with no additional risks observed during structured treatment respite (STI). Argos' monogrammed immunotherapy resulted in an unexpectedly extended delay in viral rebound, shilly-shally to summit viral load during STI and a markedly reduced viral worry when compared to pre-antiretroviral therapy (CRAFT) levels. A calculate of patients were able buy revatio 20 mg to continue the STI old times 12 weeks, and they were capable to initiate CD8+ T chamber proliferative responses to the particular antigens presented in AGS-004.

The unchangeable analysis of the End 2a details reiterates our findings from the previously reported interim analysis that AGS-004 is poetically tolerated, immunogenic, potentially serviceable and unpolluted, said Jean-Pierre Routy, M.D., diva investigator of the about at the McGill University Fitness Concentrate in Montreal. Urge onwards testing last wishes as march that AGS-004 is a doable treatment option in behalf of HIV-1 infected patients.

The Viewpoint 2a trial, AGS-004-001, was a single-arm, open-label think over of the safety, antiviral pursuit, and immunogenicity of AGS-004 in 22 HIV-infected patients in the U.S. Subjects received four doses of AGS-004 while on CRAFTINESS and then interrupted antiretroviral drug treatment while receiving think over drug.

AGS-004 is currently in a Phase 2b clinical side that see fit supplemental show the immunotherapy's efficacy an d sanctuary in the treatment of HIV patients, said Jeff Abbey, president and chief manager manager of Argos. The Phase 2b bone up on is expected to enroll a full of 42 patients in nine sites in the U.S. and Canada, and it is funded not later than the National Institutes of Haleness as function of a $32 million obligation that Argos was awarded in 2006. We are also planning to introduce a State 3 clinical attempt with our Arcelis immunotherapy in renal cell carcinoma, AGS-003, in mid-2011.

The State 2a turn over's cardinal endpoint was to assess the skill of AGS-004 to look up untouched control of HIV-1 replication, as modulated by the proportion of subjects with HIV-1 RNA levels of 1000 copies/mL on at least three anon a punctually points after STI. Secondary endpoints included the immunologic vigour as cautious by CD8+ T chamber responses to AGS-004 psychoanalysis and HIV-1 RNA fix object established after STI versus pre-ART plasma HIV-1 RNA gel point.