for those whose her2 testing was equivocal

[Lani]

two new tests for her2 have become available, FDA Approved

Monogram Biosciences Inc. said it will begin offering a new test next week to diagnose patients with a very aggressive form of breast cancer.

The HERmark test, which will cost $3,350, will require that physicians send a biopsy sample to Monogram in South San Francisco, Calif. The service is to begin July 15.

Separately the Food and Drug Administration on Tuesday approved another new test for aggressive breast cancer called the SPOT-Light test by Invitrogen Corp. of Carlsbad, Calif. A spokeswoman said the test kits will be sold to hospital laboratories for about $1,400 for a packet of 20 kits.

Unlike Invitrogen's test which is sold as a kit, Monogram's HERmark test will be marketed as a service performed at its laboratories. Such tests are certified by a route different from the FDA, under the Clinical Laboratory Improvement Amendments (CLIA) by the Centers for Medicare and Medicaid Services, the company said.

The new tests reflect the growing business of developing diagnostics that help doctors determine which patients are more likely to respond to often costly treatments and spare those who aren't likely to be helped the cost and side effects that can accompany the drugs.

The new tests check patients for a form of cancer known as HER2-positive breast cancer because the tumor cells overproduce a protein called HER2. As many as a third of the breast-cancer cases in the U.S. -- or 60,000 cases a year -- are driven to aggressive spread by overactive HER2 genes, Monogram said.

Such cancers don't respond well to conventional treatment, but are treatable with drugs such as Genentech Inc.'s Herceptin, or GlaxoSmithKline's Tykerb. Abbott Laboratories and Dako Denmark A/S also market HER2 tests.

"The best methods to assess HER2 status remain controversial. We need to find better tests," said Edith Perez, professor of medicine and chairperson of the breast cancer program for the Mayo Clinic in Jacksonville. She said further studies are needed to correlate new testing technologies with patient outcomes.



The new tests begin with a patient's tumor samples, but use different technologies to assess HER2 activity. Invitrogen's test counts copies of the HER2 gene, while Monogram's test checks for levels of HER2 protein churned out by those genes.

http://hermarkassay.com/hermark_assay_overview.aspx

Looks like the Monogram test just needs the usual formalin fixed paraffin embedded tumor specimen rather than fresh frozen tissue or any other unusual handling.