This morning's news includes two new tests for Her2, first, Fox carries the story that Monogram announces commercial availability of the HERmark breast cancer assay:
Monogram Biosciences, Inc. today announced that, effective July 15, the HERmark Breast Cancer Assay will be available to physicians throughout the U.S.
for assessment of HER2 status in patients with breast cancer. HERmark
provides a precise and quantitative measurement of HER2 total protein
and HER2 homodimer levels and will be offered as a CLIA-validated assay
through Monogram's CAP-certified clinical laboratory.
HERmark is a proprietary diagnostic that accurately quantifies HER2
total protein levels and HER2 homodimerization in patients with breast
cancer. HERmark is a CLIA-validated assay that is performed exclusively
in Monogram's CAP-certified clinical reference laboratory in South San
Francisco. Robust, accurate, sensitive and reproducible measurements of
HER2 status are reported to physicians with a turnaround time of 7
days.
Also AJC.com reports on Invitrogen's SPOTlight test: FDA Approves Genetic Test for Breast Cancer:
A genetic test to determine
whether a breast cancer patient is likely to respond to treatment with
the drug Herceptin (trastuzumab) has been approved by the U.S. Food and
Drug Administration.
The SPOT-Light HER2 CISH kit helps calculate how many copies of the
HER2 gene, which regulates the growth of cancer cells, are in tumor
tissue. A healthy breast cell should have two copies of the HER2 gene,
but patients with breast cancer may have many more. Since the gene
signals cells when to grow, divide and make repairs, too many copies
may cause cells to grow and divide too rapidly.
Both of these Her2 assays would seem to be competitors for conventional IHC analysis performed using microscopy and/or with a digital image analysis application.