MedTest Dx Manufacturing FDA Approved Quantitative Test for G6PD for COVID-19 Treatment
MedTest Dx, Inc., an established solution provider for clinical diagnostic testing, is providing a critical tool in the fight against COVID-19 with its Pointe Scientific-branded assay for the highly sensitive quantification of G6PD in whole blood. Understanding the G6PD status of COVID-19 patients is essential to prevent severe adverse reactions to Chloroquine and Hydroxychloroquine, increasingly being aimed at tackling the pandemic.
G6PD deficiency is the most common enzymatic blood disorder, affecting some 400 million people worldwide. The g6pd Deficiency Foundation estimates that the United States' frequency of G6PD is between 4-7 percent. However, in African-American males, the prevalence is about 12 percent. Having this disorder and exposure to specific triggers can potentially lead to a hemolytic crisis, further exasperating the COVID-19 patient’s health issues.
Regulators have required drug manufacturers to include a contraindication regarding administration of Chloroquine or Hydroxychloroquine to those with a G6PD deficiency. Most patients harboring this disorder do not know that they have it, which makes testing prior to administration critical. It is for this reason that the World Health Organization (WHO) recommends that, where feasible, all patients should be tested for G6PD deficiency before such drugs are administered. This statement is echoed by the Centers for Disease Control and Prevention (CDC).
“Unless the patient has a medical episode that uncovers it, most people are unaware that they have the G6PD deficiency,” says Keely E Harris, president of the g6pd Deficiency Foundation. “Physicians having the knowledge of a patient’s G6PD status provides them a complete picture as they choose and monitor therapies.”
MedTest Dx’s G6PD assay, designed to run concurrently with standard diagnostic tests such as hemoglobin determination on a wide range of analyzers, benefits from on-board lysis to achieve results in just minutes.
“With resources currently stretched to the limit by the COVID-19 pandemic, healthcare institutions require a streamlined solution to quickly screen patients prior to beginning their course of treatment,” says Wayne Brinster, Chief Executive Officer of MedTest Dx. “Our assay rapidly informs both the presence and severity of the G6PD deficiency to aid clinical decision-making. Looking at the quantitative results, along with the WHO-defined G6PD deficiency levels, treatment decisions based on risk and benefit assessment can be made.”