Finding Lessons in Veridex's Decision to Scuttle GeneSearch

A report in the Wall Street Journal today describes the rise and fall of Veridex's GeneSearch breast-lymph node cancer assay, which the company deep-sixed last month on limp demand.

FDA approved the intra-operative real-time RT-PCR test in July 2007 and called it the “first molecular-based laboratory test for detecting whether breast cancer has spread to nearby lymph nodes.”

But in December 2009 Veridex quietly and abruptly stopped selling it. "We were just finding that adoption of this as a tool to manage metastatic breast cancer has been relatively low," according to J&J spokesperson Devon Prutzman.

Boom to Bust

According to the Wall Street Journal article, physicians originally "hailed" the GeneSearch "as a revolutionary technology that could help spare women undergoing tumor-removal surgery from having to get follow-up operations."

But eventually they became "less enthusiastic," and grew to be "content with older [pathology-based] diagnostic tests," according to the report, written by Peter Loftus.

Indeed, the GeneSearch's withdrawal is "a lesson that cutting-edge technology … doesn't always translate into commercial success if there are questions about the product's costs and benefits," Loftus writes.

Looking back it appears the test was doomed from the beginning. In my blog post earlier this month I said what doomed GeneSearch were its high startup costs, its level of difficulty, and its relatively high prevalence of false-positives.

On the cost side, a 2007 report by the Australian government found that "[a] capital investment of $40,000 is required for establishment of the GeneSearch BLN Assay at a particular site."

In addition, 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."

"It was a good idea. It just wasn't really as practical as people would like," surgeon Anthony Lucci, who performs breast-tumor removals at the University of Texas MD Anderson Cancer Center in Houston, was quoted as saying in Loftus' story.

And that was just one facet of J&J's decision to bail. In his piece, Loftus quotes Julie Margenthaler, assistant professor of surgery at Washington University School of Medicine in St. Louis, who said her center considered GeneSearch but ultimately backed away from the idea.

She cited "relatively high startup costs" — which she also estimated at $40,000 to $50,000 — "plus logistical issues, such as where to put the GeneSearch machine and how to maintain it," Loftus writes. "GeneSearch's potential for false positives meant 'you may be doing more surgery than you really need to.'"

According to Loftus, in the final analysis "[s]ome doctors felt [GeneSearch] didn't offer enough of a benefit over older diagnostic methods [such as standard frozen-tissue pathology] to justify its high cost. Others had concerns about the test's rate of false positives."

Speaking to Loftus, Prutzman said that while GeneSearch had "scientific merit," physician adoption was low "because currently available intra-operative methods are proving satisfactory for most clinicians and patients."

In fact, he reports that even physicians who participated in a clinical trial that led it the test's approval in 2007 "didn't immediately replace frozen section with GeneSearch, instead using the two methods in conjunction with each other."

Another of GeneSearch's weaknesses is its relative difficulty. MD Anderson's Lucci told Loftus it would have taken "special training and special personnel" to run the GeneSearch unit, compared with using frozen sections, which are routine in most clinical labs.

"We never considered it ready for prime time," Mary Daly, chair of clinical genetics at Fox Chase Cancer Center in Philadelphia, was quoted as saying in the Journal article.