Today, May 16, at the ASTM International May Committee Meeting in Denver, Colorado, Massachusetts stem cell biotechnology company Asymmetrex will present a proposal for an interlaboratory evaluation of the company’s AlphaSTEM Test™. Approval of this ASTM evaluation will be an important step in Asymmetrex’s plan to establish the AlphaSTEM Test™ as a stem cell industry standard for specific and accurate counting of therapeutic adult tissue stem cells.
In an FDA-contracted Standard Coordinating Body Workshop held at the National Institute of Standards and Technology in Rockville, Maryland, March 18-19 of this year, Asymmetrex founder and director James L. Sherley, M.D., Ph.D. predicted a sea change in thinking on the feasibility of standards for counting therapeutic adult tissue stem cells. Many of the gathered participants dismissed this idea. Few argued against the importance of having a standard for quantifying the number of stem cells in stem cell treatments, stem cell manufacturing, and drug development. However, many were of the view that establishing a standard was out of the question because adult tissue stem cell science was not sufficiently mature to support a method for counting its essential principals.
Sherley, one of a few adult tissue stem cell experts in the workshop, argued passionately to the contrary, based on the merits of his company’s AlphaSTEM Test™, the first reported technology for achieving specific and accurate counting of therapeutic adult tissue stem cells in complex tissue cell preparations. Asymmetrex’s participation in the March SCB Workshop led to an invitation from ASTM International staff for the company to present a proposal for an interlaboratory evaluation of its new test at a future ASTM Committee meeting.
The American Society for Testing and Materials International is a 121-year-old organization that was founded and exists to improve and assure the quality of a vast landscape of industrial manufactured products. ASTM accomplishes this service to humanity by developing worldwide consensus standards for industrial testing and industrial materials. Though founded on standards for factory operations and building materials, its purview now extends well beyond to medical procedures and human tissue cell quality.
Interlaboratory evaluations are an important step on the path to standard certification by ASTM. Asymmetrex gave an initial presentation of its tissue stem cell counting standard concept at an ASTM International Committee Meeting in Washington, D.C. in November 2018. An interlaboratory evaluation was recommended at that time. In today’s proposal presentation, the company will present test property data from its three current cell culture contractor sites, Toxikon Corporation in Massachusetts, Drik in Oklahoma, and the MTECH-BAF in Maryland. The contractor data establish the general high quality of the AlphaSTEM Test™ for determinations of several different therapeutic human adult tissue stem cell types. The proposed interlaboratory study will go further to evaluate similar test properties across five to ten different academic and industrial labs all testing the same source of human tissue stem cells.
Based on the excellent intrinsic test properties observed for Asymmetrex’s individual contractors, Sherley is optimistic that the interlaboratory study will be similarly supportive for moving on to the final stages of ASTM standard certification. “We want for stem cell medicine what ASTM wants for all industries that serve humanity: ‘Helping our world work better.’ Establishing a standard for counting therapeutic adult tissue stem cells will help stem cell medicine work better.”
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. Asymmetrex’s founder and director, James L. Sherley, M.D., Ph.D. is an internationally recognized expert on the unique properties of adult tissue stem cells. The company’s patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of successful commercialization of human adult tissue stem cells for regenerative medicine and drug development. In addition, the portfolio includes novel technologies for isolating cancer stem cells and producing induced pluripotent stem cells for disease research purposes. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the “AlphaSTEM Test™”) for use in stem cell transplantation therapies and pre-clinical drug evaluations.