The Tissue of Origin Test, a microarray-based gene expression assay commercialized by the defunct firm Pathwork Diagnostics, may soon become available again.
Los Angeles-based Response Genetics announced this week that it has agreed to acquire all intellectual property, know-how, data, equipment, and materials formerly owned by Pathwork that relate to the TOO test.
The agreement includes a $200,000 cash payment and the issuance of 500,000 shares of Response Genetics' stock with a lock-up period through June 2014. In a filing with the US Securities and Exchange Commission, Response listed the total deal as being worth as much as $1.35 million.
The TOO test compares the expression of 2,000 genes in a patient's tumor with a panel of 15 known tumor types that represent 90 percent of all cancers in order to diagnose patients who have metastatic, poorly differentiated, and undifferentiated cancer.
Pathwork gained US Food and Drug Administration clearance for the test to be used on frozen samples in 2008 and on formalin-fixed, paraffin-embedded samples in 2010. The company also garnered Medicare reimbursement in 2011 before it shuttered its operations earlier this year.
By acquiring Pathwork's assets, Response Genetics gains content that "addresses the needs of both pathologists and oncologists [and] further expands both our technology and testing base," CEO Thomas Bologna said in a statement.
It is unclear when Response plans to begin offering the test from its CLIA-compliant laboratory. An email seeking comment was not returned in time for this publication.
Response currently offers sequencing, RT-PCR, and fluorescence in situ hybridization-based tests for lung, gastric, and colon cancers, and melanoma. It relies on internally developed methods to extract RNA from FFPE tissue.
Before Pathwork stopped operations, the TOO test was generating "rapidly growing sales" with 2012 sales in the "mid-seven figure range," Response said.
Pathwork did not provide a statement on the deal, nor did it comment when it ceased operations earlier this year. As BAN sister publication Pharmacogenomics Reporter reported at the time, a recorded message informed callers to its office numbers that Pathwork had "entered into a general assignment for the benefit of creditors" (PGx Reporter 4/10/2013).
It is also unclear how much funding Pathwork had raised since it was founded in 2006. A number of investment firms had funded the company, including Alta Partners, Abingworth Management, Advent Venture Partners, Novus Ventures, Prospect Venture Partners, Venrock, and Versant Ventures. Since its launch, Pathwork had publicly disclosed raising a total of $61 million in three private funding rounds.