HERmark Test Commercially Available From July 15: Monogram

Starting July 15 Monogram Biosciences’s latest HERmark breast cancerdefine assay will be made available to doctors throughout the United States, the US based international biotechnology laboratory announced on Tuesday.

Unlike the currently used semi-quantitative measures which determine HER2 status, HERmark provides a precise and quantitative measurement of HER2 total protein and HER2 homodimer levels. The results of the test aid in deciding whether or not the patient will benefit from the use of Herceptin.

Medically, a healthy non-cancerous breast cell has two copies of the HER2 gene. These genesdefine send across signals to breast cells and prompt them when to divide, grow or make repairs. Patients with breast cancerdefine are known to have more than two copies of the HER2 gene, thus aggressively prompting them to overproduce HER2 protein, as a result, the cells grow and divide too quickly.

Looking at the rate of gene amplification, Monogram's test quantifies HER2 total protein levels.

A CLIA-validated assay that will be performed exclusively in Monogram's CAP-certified clinical reference laboratory in South San Francisco, HERmark is an accurate and sensitive diagnostic test with a turn around time of 7 days.

Nearly about 182,000 women are diagnosed with breast cancer each year, out of which as high as 60,000 cases are triggered by aggressive spread by overactive HER2 genes.

With the availability of HERmark an expected 15 to 20 percent of breast cancer patients determined by conventional technologies to be HER2- negative would be reclassified, health experts hope.