Gold Standard Diagnostics, Corp. Receives FDA Clearance for the AIX1000 System

AIX1000

DAVIS, California, (March 7, 2016) — Gold Standard Diagnostics, Corp. announced today that the U.S. Food and Drug Administration issued a 510(k) clearance for the AIX1000TM Rapid Plasma Reagin (RPR) Automated Test System. The AIX1000TM is a fully automated system for RPR syphilis testing.

The AIX1000TM system fully automates the RPR test procedure from sample loading to result interpretation for titers and screens. Digital images of each result are retrievable on demand, for review anytime. Interpretation of results is completed by a pattern-recognition algorithm that is both objective and consistent.

John Griffiths, CEO said, “We are excited to bring this new, innovative technology to clinical laboratories. The AIX1000TM automates a test that has historically been manual, labor intensive and subjective. This fully automated solution allows laboratories to continue to perform the traditional syphilis testing algorithm while improving efficiencies and reducing costs. RPR is now fully automated with all of the features and benefits of an immunoassay processor.”

About Gold Standard Diagnostics, Corp.

Gold Standard Diagnostics, Corp. is a privately held clinical diagnostics company based in Davis, California. The company develops, manufactures and distributes a portfolio of instrumentation and diagnostic products to clinical laboratories in the U.S., EMEA, Asia, and South America. Current product offerings include the Thunderbolt® instrument, an open format platform for enzyme and chemiluminescence immunoassays, and an extensive menu of serology tests used in the areas of autoimmune disease, infectious disease and endocrinology.

AACC Recap - Thank You!

The 2015 AACC Clinical Lab Expo was another great year for Gold Standard Diagnostics.

We will be following up on the many great meetings and contacts made during the event over the next few weeks.

In the meantime, please don't hesitate to  contact us with any questions you may have about our instrumentation, reagents, service or company in general.

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

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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,

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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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