Veridex (Warren, New Jersey), a cancer diagnostics company that was formed by Johnson & Johnson (J&J; New Brunswick, New Jersey) in 2001, made its public debut at last year's annual meeting of the American Society of Clinical Oncology (Alexandria, Virginia) in New Orleans (Medical Device Daily, June 16, 2004).

Less than a year later, Veridex has one FDA-cleared product, a second planned to hit the market early next year and a third that was the subject of a study just published in The Lancet (Feb. 19, 2005).

In discussing its activities, David Atkins, PhD, general manager for molecular diagnostics at Veridex, said he is pleased with the company's progress vs. the competition.

“I think the problem that we all face in the cancer diagnostic world is there's not an awful lot out there, so in many cases we're having to reset the gold standard and understand the gold standard,“ Atkins told Medical Device Daily.

The Lancet article published earlier this month covered Veridex's experimental prognostic assay that, at the time of diagnosis, identifies which breast cancer patients are at greatest risk for metastatic disease. It did this with more than 90% sensitivity, according to the study.

Veridex said that it is the first prognostic molecular marker that could be used with all lymph-node-negative breast cancer patients, regardless of age, tumor size and grade, or estrogen receptor/progesterone receptor status.

“What we've described in that Lancet paper is that with relatively high accuracy, we can identify patients with diagnosis who have a very high likelihood of relapsing, and then those who look like they are very unlikely to relapse,“ said Atkins, a senior author of the study. “The ultimate aim here is to use this information in conjunction with everything else a physician uses to try and influence a decision about the precise mix and extent to which patients get treated with drugs and chemotherapy.“

The most common treatment approach to a diagnosis of breast cancer currently is to attack the disease as if it is likely to recur. And that means that the patient undergoes chemotherapy.

The work was the result of a collaboration between the Erasmus Medical Center-Daniel den Hoed Cancer Center (Rotterdam, the Netherlands) and Veridex. Researchers analyzed tumor samples of 286 breast cancer patients treated during 1980-95, all of whom were lymph node negative and did not receive adjuvant chemotherapy. The samples represented patients from routine practice, from all age groups and who were both ER and PR positive and negative.

Using GeneSearch, one of Veridex's two technology platforms, a genomic signature was constructed using gene expression data of 76 genes derived from extensive tumor gene expression profiling by Veridex researchers. That signature showed 93% sensitivity and 48% specificity in a subsequent independent testing set of 171 lymph-node negative patients.

Veridex said that the gene profile was “highly informative in identifying patients who developed metastatic disease within five years.“ It also was a strong prognostic indicator of development of metastases in the subgroups of 84 premenopausal and 87 postmenopausal patients, and in patients whose tumors measured 10 mm to 20 mm, a group for whom prediction of prognosis is especially difficult, according to the company.

“We actually looked at just about every gene in the human genome in each of those patients in the primary tumor, and then we asked the question is there a relationship between a minimal set of genes that predicts whether or not the patient is going to relapse,“ Atkins said.

To accomplish this, Veridex used a device manufactured by its partner, Affymetrix (Santa Clara, California). That device, Atkins said, is “a silicon-based device that can be used in measuring small differences in a large number of genes,“ which is a GeneSearch platform.

That prognostic signature was later independently validated in a separate consecutive series of about 150 patients from four medical institutions.

Veridex also “constructed a little mathematical model based on 76 genes from that group of patients,“ Atkins said. The company took the primary tumor, looked at the 76 genes that it knew were “informative.“

“Then basically, we just assigned a mathematical score to each patient based on the relative levels of the different genes,“ he said. That score indicates whether a patient was likely to relapse.

“We've looked at close to 400 patients,“ Atkins said. “You know, we have competitors who would probably go to market on 400 patients.“ But he said that Veridex would like to see results from one more independent study, which would take from six to nine months. That results in the product likely hitting the market in 12 to 26 months.

Veridex's first product, which was cleared by the FDA last year, is for prediction of “progression-free and overall survival“ in patients with metastatic breast cancer. The company expects its second product to be a test for detecting the presence or absence of cancer in lymph nodes — important because during surgery for breast cancer, “one of the key decisions in managing breast cancer,“ Atkins said, is to determine during that surgery whether the lymph nodes are positive or negative for breast cancer.

“The overall benefit here is that if you can provide that information more quickly, then the surgeon can manage the breast cancer procedure to be more effective and less traumatic for the patient,“ he told MDD.

“All going well,“ Atkins said that product, which is being tested “rigorously“ now, is expected to be on the market following FDA approval in 1Q06.