By Kirell Lakhman
Johnson & Johnson unit Veridex has pulled its GeneSearch breast cancer-metastasis test from the US and European markets because of "relatively low" adoption of the test, according to Dow Jones Newswires.
Veridex in December stopped selling the real-time RT-PCR-based test, which was designed to determine intra-operatively whether breast cancer had spread to nearby lymph nodes.
"We were just finding that adoption of this as a tool to manage metastatic breast cancer has been relatively low," spokeswoman Devon Prutzman was quoted as saying.
But relatively high start-up costs, a tendency toward false positives, and limited availability could have doomed the test from the beginning.
FDA approved the test in July 2007. As Sample sister publication Pharmacogenomics Reporter said at the time, the agency called it the “first molecular-based laboratory test for detecting whether breast cancer has spread to nearby lymph nodes.”
The test operates on Cepheid’s SmartCycler platform and can generate results in 35 to 40 minutes — which PGx Reporter called a "marked improvement" over the two to three days it typically takes to analyze tissue using standard pathology techniques.
But according to Dow Jones Newswires, "doctors appear to be satisfied with other methods of detection," such as pathology — and there could be some practical rationale for that thinking.
Despite GeneSearch's ability to test up to 50 percent of a sentinel node, as opposed to 5 percent typically examined under a microscope, FDA said the test yielded “slightly more false positive results” than immediate microscopic examination.
Comparisons of GeneSearch to intra-operative microscopic examination showed that GeneSearch yielded fewer false-negative results but gave “slightly more false positive results,” FDA said.
It's also a costly endeavor for a hospital. According to a 2007 report by the Australian government, "[a] capital investment of $40,000 is required for establishment of the GeneSearch BLN Assay at a particular site."
A kit comprising 30 tests will set the hospital back another $2,250, "while the test itself would cost about $300 per patient, assuming two lymph node tests and two controls are performed per patient."
The Aussie government concluded that "[t]hrough the reduced burden on pathologists and an increased sensitivity, and therefore reduction in second surgery costs, the GeneSearch BLN Assay is predicted to be more cost effective than current comparators, although this is not supported by evidence at this early stage in the product’s development."
Another reason why the test has been met with "relatively low adoption," at least in the US, is that only 10 labs in the country performed the test, which included centers of excellence at Georgia Esoteric and Molecular Labs in Augusta; Morton Plant Mease Health Care in Clearwater, Fla.; and Woman's Hospital in Jackson, Mo.