Discovery of

BioStratum's collaborating laboratory at the Karolinska Institute, directed by BioStratum cofounder Dr. Tryggvason, was the first to discover that metastatic tumors produce the basal lamina protein laminin g2 at the tumor's invasive front. It appears that tumor cells utilize this protein in a basic mechanism of migration to invade surrounding tissue. This finding has been published in leading scientific journals and confirmed in a number of laboratories throughout the world.

Subsequent studies comparing the laminin g2 staining patterns of tumor biopsies and patient outcome show a strong correlation between the level of laminin g2 detected and the presence of invasive, metastatic cancer. This pattern has thus far been demonstrated for colon, cervical, breast, vaginal and larynx cancers, and other types of cancers are currently under investigation. In the case of cervical cancer, staining for laminin g2 can detect the presence of early invasive cancer when traditional stains are reading negative for cancer. These studies have been performed by leading oncologists at the Karolinska Institute, Sweden.


We have developed a diagnostic test that utilizes this scientific advancement, g2-Metastain™. Clinical tests have shown that g2-Metastain™ can detect the presence of early invasive cancer whereas currently available tests failed to do so. Thus, g2-Metastain™ has the potential to become a highly important tool for treating cancer patients. The doctor can use this information to help establish a more appropriate and hence potentially more efficacious anti-cancer therapy. A final clinical study utilizing this test is underway, and regulatory approval is anticipated in 2001.

Market analysis and projections

The number of biopsies conducted in the United States is estimated to be approximately 7 million per year. Biopsies of the gastrointestinal tract and breast are the most frequently performed. We anticipate charging $50/test.
The market for this product in Europe is estimated to be approximately equal to that in the United States, and the market in Japan is estimated at half the U.S. market.

The anticipated initial application of g2-Metastain™ will
be to determine the invasive and metastatic potential of biopsy specimens that are determine to be malignant
using traditional staining procedures. As oncologists become familiar with the use and utility of g2-Metastain™, we expect that its use will expanded to initial biopsy screening, particularly in light of the fact that g2-Metastain™ has been shown to detect early invasive cancer when traditionally used stains still read negative.