July 24, 2013, Davis, CA – Gold Standard Diagnostics, Corp. (GSD, www.gsdx.us), a leading manufacturer and marketer of clinical laboratory instrumentation and assays for the in vitro diagnostics market, announced 510k FDA Clearance of its 25-OH Vitamin D, Total ELISA. The competitive assay strongly correlates with established LC/MS, EIA and Chemiluminescence methods, and offers high sensitivity and specificity over a wide dynamic range. The assay provides a cost-effective Vitamin D testing option, even at lower volumes.
June 19, 2013, Davis, CA – Gold Standard Diagnostics, Corp. (GSD, www.gsdx.us), a leading manufacturer and marketer of clinical laboratory instrumentation and assays for the in vitro diagnostics market, announces new Line Immunoassay technology for Lyme confirmation testing. GSD gives clinical laboratories an FDA cleared, improved option for serological confirmation testing for Lyme disease according to the CDC-recommended two-step process. Both the IgG and IgM line blots are substantially equivalent to traditional Western Blot technology, but offer advancements in usability and objectivity through use of Line Immunoassay technology. GSD's LIA test strips offer numerous enhancements including: improved sensitivity and specificity, consistent results, large lot sizes, easier handling and automation options.
"The demands of today's clinical laboratories require consistent, reliable and user-friendly products," said John Griffiths, CEO of Gold Standard Diagnostics. GSD's innovative
Davis, CA, March 19th, 2013 – Gold Standard Diagnostics, Corp. (GSD, www.gsdx.us), a leading manufacturer and marketer of clinical laboratory instrumentation and assays for the in vitro diagnostics market, today announced it has established distribution partnerships for the ThunderBolt® Automated Immunoassay Analyzer in 18 countries throughout Europe, Latin America, Asia and the Middle East since the official global launch in early 2012. ThunderBolt® sales in the U.S. market also continue to grow as laboratories recognize the powerful and seamless automation solutions that Gold Standard Diagnostics offers.
Mature and emerging markets alike have responded to the comprehensive suite of fully automated features that the compact and cost-effective ThunderBolt® offers. As a result, the global sales and marketing network has grown substantially over the past year. Established markets, such as those in Europe, have widely accepted the ThunderBolt® with installations in Germany, Spain, Finland, Austria, Switzerland and Belgium. Additional countries with installed units include South Korea, Mexico, Vietnam, and Puerto Rico. Distribution partnerships and sales in China, Brazil, India and Canada are also imminent.
November 14th, 2012, Davis, CA – Simplify parasitology testing with Gold Standard Diagnostics’ (GSD) comprehensive line of assays for parasites and worms. GSD’s extensive portfolio of parasite tests provides laboratories with a reliable,
Davis, CA, September 5th, 2012 – Simplify and improve your clinical laboratory with single-step, direct ELISA measurement of Free Testosterone from Gold Standard Diagnostics (GSD). Compared to indirect, multi-step testing algorithms, GSD’s FDA Cleared Free Testosterone products save time and money while reducing the possibility of errors.
Reduce errors and cost with single-step Free Testosterone…
The ability to directly measure Free Testosterone eliminates the complication of taking multiple indirect measurements and calculating Free Testosterone through an algorithm. Diagnostic technologies have inherent limitations in terms of both precision and accuracy. Combining multiple procedures exacerbates these limitations and increases both the cost and opportunity for errors.
Generate multiple results and revenue from a single well.
Davis, CA, August 7th, 2012 – Simplify clinical diagnosis of autoimmune disease with Gold Standard Diagnostics’ (GSD) comprehensive offering of multiplex autoimmune assays. GSD has partnered with Theradiag (formerly known as Biomedical Diagnostics, BMD) to provide laboratories with the FIDIS™ suite of products for detection of the autoantibodies associated with connective tissue diseases, CREST syndrome, lupus erythematosus, rheumatoid arthritis, vasculitis, polymyositis, dermatomyositis, scleroderma, Sjögren syndrome, thyroid syndromes, Celiac and many others. Major benefits of the FIDIS™ multiplex product suite include: up to 13 results in a single well, reduced labor and overhead, increased throughput, small sample volume and full automation.
Simplify Your Laboratory Experience with Multiplex…