Pharmaceutical Business review

AntiCancer’s diagnostics unit wins FDA clearance for portable homocysteine test

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.”