New Molecular Diagnostic Standards Launched by Phthisis Diagnostics
12 Oct 2012

Phthisis Diagnostics has launched a new line of molecular standards, the G-Sphere® Molecular Standards. The new line quickly follows the introduction of the company’s second product in its Simply Molecular® line of enzyme-based extraction kits for rapid sample preparation prior to PCR applications in laboratories. Phthisis Diagnostics, based in Charlottesville, VA, is a rapidly growing biotechnology company developing a range of innovative molecular diagnostics technologies.

The G-Sphere® Molecular Standards are synthetic genes that provide safe, stable, consistent, and abundant controls for virtually any organism and any molecular assay. Molecular diagnostic laboratories face difficulties in obtaining consistent and reliable controls to monitor the performance of molecular assays and instruments. This new Phthisis product line, the only one currently offering such standards for parasites, is an innovative solution to improve and simplify quality control procedures. The Company has expanded its staff to allow special focus on the development of the new line. Elizabeth Nelson is a Research Technician designated as the Project Lead for the G-Sphere® Molecular Standards.

This custom product is supplied as 100 reaction vials that come with dilution buffer and instructions for use. In addition to custom orders, a growing list of G-Sphere® Molecular Standards have been developed for various parasites, including Cryptosporidium, Giardia, Entamoeba, Plasmodium, Microsporidia, and other analytes of particular interest to public health laboratories.

“This new product provides much needed quality control standards to molecular laboratories,” explains Crystal Icenhour, PhD, President and Chief Science Officer at Phthisis Diagnostics. “We have developed a consensus approach to creating molecular standards, giving the users greater flexibility. We are excited to introduce this product line because it will enable molecular laboratories to better control diagnostic assays. In addition to being a stand-alone product, these molecular standards will be used as positive controls for our diagnostic product line.”

Phthisis Diagnostics will be presenting its new product line for the first time at the 2012 Association for Molecular Pathology (AMP) Annual Meeting in Long Beach, CA, in October. Interested laboratories are encouraged to stop by Phthisis’ Booth # 332 at this meeting to learn more about G-Sphere® Molecular Standards.

Phthisis Diagnostics products are developed and manufactured in the USA to ISO 13485 standards in a QSR and cGMP compliant facility and are designated as general purpose reagents.

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Sonia Nicholas
Clinical Diagnostics Editor  




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