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news.The A/C diagnostics unit of AntiCancer, a biotechnology company, has received FDA clearance to market its A/C portable enzymatic homocysteine assay on the A/C Diagnostic Reader.
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The new homocysteine assay uses a genetically engineered enzyme specific for homocysteine. The assay will be able to serve the need for widespread testing for homocysteine, a risk factor for cardiovascular and other diseases, the company said.
According to AntiCancer, the A/C portable enzymatic homocysteine assay can measure total homocysteine (tHCY) in a three-step single-enzyme assay with a small portable fluorescence reader, the A/C Diagnostics Reader, and can assist diagnosis and treatment of hyperhomocysteinemia, a risk factor for cardiovascular disease and other diseases.
This test is said to be precise and can be carried out in a small lab, a doctor’s office or a pharmacy as it requires small amounts of blood, even from a finger prick. The assay kit is only for in vitro use.
Yuying Tan, product manager for the A/C portable enzymatic homocysteine assay, said: “The simplicity of this test enables an economical price structure for the test kit. This gives us the possibility for gaining a significant share of the homocysteine test market.”