FDA clears device to quickly, accurately ID hemoglobin variants

Successor to system used in labs working in sickle cell, similar diseases

Andrea Lobo, PhD avatar

by Andrea Lobo, PhD |

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The U.S. Food and Drug Administration (FDA) has cleared for use Trinity Biotech’s Premier Resolution System, an automated analyzer that can quickly and accurately detect and quantify hemoglobin variants.

Hemoglobin is the protein that red blood cells use to carry oxygen through the bloodstream. Several hemoglobin variants identified by this system are considered disease causing for conditions that include sickle cell disease (SCD).

“We welcome the news that our Premier Resolution has received 510(k) clearance from the FDA,” Aris Kekedjian, chairman and CEO of Trinity Biotech, said in a company press release. 510(k) clearance is a regulatory pathway to market a medical device in the U.S.

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Premier Resolution System identifies, quantifies hemoglobin S of sickle cell

The system, Kekedjian added, can identify a “broad range of rare hemoglobin variants” with “accuracy, speed and value.”

SCD is caused by mutations in the HBB gene that lead to the production of an abnormal form of hemoglobin, called hemoglobin S. The mutated version of the protein tends to form clumps inside red blood cells, causing them to acquire the sickle-like shape that characterizes the disorder.

Other hemoglobin variants include hemoglobin A, the most common type found in healthy adults, hemoglobin A2, and hemoglobin F, the main form of hemoglobin produced during fetal development.

The Premier Resolution System is a lab-based diagnostic system that combines the sensitivity and specificity of high-performance liquid chromatography (HPLC) with automation software to quantify hemoglobin F and A2 and detect more than 200 common and rare hemoglobin variants, the company stated.

HPLC is a technique used to separate, identify, and quantify the components present in a mixture. It relies on a pump to pass a liquid containing the mixture to be analyzed through a column filled with a material that will interact differently with each component.

The system is designed to provide the maximum amount of information in the shortest time possible, with a fully automated and a flexible approach for the precise quantification of hemoglobin variants, Trinity Biotech reported on a webpage.

It is presented as the successor to another diagnostic platform the company markets, called Ultra System, used in laboratories across U.S. to identify hemoglobin variants that can cause SCD and thalassemia, another genetic disease marked by problems with this protein’s production.

“This is an important milestone in the transformation of Trinity Biotech, which is anchored by the expansion of our hemoglobin and diabetes franchises. The Premier Resolution represents the first in a number of expected product roll-outs and investments in this space,” Kekedjian said.