Biotech Case Study


Pathwork Diagnostics used discoveries in genomics and the Affymetrix “GeneChip” microarray platform to address unmet diagnostic testing needs in oncology. The company’s first diagnostic test, the “Tissue of Origin” test, received FDA approval for identification of the source of cancer cells. Pathwork Diagnostics first came to US Marketing Services for marketing assistance in determining the market opportunity and positioning the differentiation benefits of a new oncology recurrence test.

US Marketing identified and interviewed many of the top tier oncologists and pathologists in the country to discuss the need for and benefit of the proposed test. Then US Marketing identified what Pathwork Diagnostics would need to do in order to make a successful new product launch and described in detail what the market obstacles might be.


Together US Marketing and Pathwork Diagnostics evaluated whether to proceed with the expensive FDA approval process on this test product.

Pathwork Diagnostics returned to US Marketing for more marketing counsel. The next US Marketing and Pathwork Diagnostics project was designed to identify four additional oncology sectors and to comprehensively explore and establish priorities based upon apparent market opportunities for potential new tests for their pipeline. Since our work with Pathwork, the company suffered the effects of low and inconsistent reimbursement for its microarray gene expression tests and so in spite of receiving two FDA clearances and studies that validated its work, unfortunately the firm closed in 2013.