Gold Standard Diagnostics’ and DIAsource ImmunoAssays’ 25-OH Vitamin D, Total Assay Receives 510k FDA Clearance

Achieve Cost Effective, Accurate and Reproducible Results Regardless of Testing Volume

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 can be automated on a variety of instruments, providing a cost-effective Vitamin D testing option, even at lower volumes.

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Next-Generation Lyme Disease Testing Becoming Widely Accepted Amongst Clinical Laboratories

Achieve Accurate, Reproducible Results with FDA Cleared  Borrelia burgdorferi B31 Confirmation Blots

lyme_borreliaJune 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 quality products, automation options, and excellent service meet those needs. The advanced technology of the GSD Lyme LIA can improve test results, workflow efficiency and cost effectiveness for these clinical laboratories."

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Gold Standard Diagnostics Expands ThunderBolt® Laboratory Automation International Sales and Marketing Network

Strong domestic and international sales expected for 2013 and beyond.

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.

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Streamline Parasitology Testing With Reliable Procurement and Broad Product Offering

Gold Standard Diagnostics Parasitology Assays

Hard-to-find parasite and worm assays delivered on time by Gold Standard Diagnostics.

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, single-source procurement option and access to a wide range of highly-consistent and cost-effective serological and stool assays.

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In Wake of Fungal Meningitis Outbreak, Laboratories Must Prepare for Increased Aspergillus Testing Demand

Laboratories Must Prepare for Increased Aspergillus Testing Demand  in Wake of Fungal Meningitis Outbreak

Full line of Aspergillus fumigatus ELISA test options available from Gold Standard Diagnostics.

October 9th, 2012, Davis, CA – Gold Standard Diagnostics’ (GSD) comprehensive line of Aspergillus diagnostic tests enables clinical laboratories to prepare as the number of Aspergillus tests ordered is expected to rise significantly in the wake of 17,676 vials of potentially fungus-tainted steroids that have been recalled.

GSD’s complete solution for detection of Aspergillus IgG, IgM and IgA antibodies enables accurate detection of the fungus related to the current proliferation of fungal meningitis. The number of confirmed cases now exceeds 100 across 23 states, and many more cases are possible as symptoms may take up to a month to emerge. Laboratories should immediately procure sufficient Aspergillus tests to meet this expected increase in demand.

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Enhance Free Testosterone Testing with FDA Cleared Direct Detection

Eliminate extra steps, save time and money.

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.

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