Monday, April 16, 2018

Very Brief Blog: Behind The Headlines, Ongoing Life for "Tumor of Origin" FDA-Cleared Test

In a Genomeweb article this week, we read that Cancer Genetics (which has been in the news for financial problems) has gotten a special 510(k) clearance for its Tissue of Origin test.   Tissue of Origin tests are useful in cases where a patient presents with metastatic cancer of unknown or uncertain origin.   (Terms include tissue of origin test, tumor of unknown origin TUO, cancer of unknown primary CUP; see one recent review here.)

Genomeweb does not mention the long journey of this test, which classifies 15 tumor types. 

Pathwork Diagnostics developed the test just about ten years ago, and got FDA de novo clearance in June 2010.  (t's not clear yet just what kind of update the "new" FDA clearance represents.)

Pathwork  was folded into LA-based Response Genetics in August 2013.  This was described as "salvaging" the Pathwork test for a mere $1.3M.   According to Crunchbase, during its lifespan, Pathwork Diagnostics had garnered $64M in investments.

Response Genetics, in turn, was in bankruptcy when it was acquired by Cancer Genetics in August 2015, here

Currently, in April 2018, Cancer Genetics is the focus of lawsuits and is working to leverage its strategy and access for ongoing business operations.  CGIX stock has slipped from about $18 to about $1.50 over four years, with a current market cap of $40M.  Revenue has been circa $25-30M the past two years against net income of -$15M to -$20M.