By Tony Fong
NEW YORK (GenomeWeb News) – Genetic test maker Pinpoint Genomics has moved into commercialization phase with the launch of its first product, a prognostic test for non-small cell lung cancer.
The Pinpoint Dx Lung Assay, launched in late January concurrent with the publication of a validation study in The Lancet demonstrating the test's utility, is available only in the US for now. Unlike many other genetic tests for NSCLC, Pinpoint's assay is targeted not at diagnosing the disease or as a companion diagnostic, but for determining which patients may benefit from chemotherapy after surgical removal of their tumors.
NSCLC is the most common form of lung cancer accounting for about 85 percent of all lung cancer cases. At issue is that even after having their tumors removed, about one-third of NSCLC patients will have their cancer recur, and eventually they will die from the disease, David Berryman, Pinpoint's founder and CEO, told GenomeWeb Daily News in a recent interview.
"That leaves you with the dilemma of giving everybody chemo to save that one-third, or giving nobody chemo because you don't want to expose the two-thirds [who] are fine to the dangers of chemotherapy," he said.
By providing a tool to better identify those patients at risk for NSCLC recurrence, physicians will be able to make better informed decisions about who should receive therapeutic treatment after surgery.
The Pinpoint Dx Lung Assay uses quantitative, real-time PCR technology and leverages research headed by David Jablons, a professor in thoracic oncology at the University of California, San Francisco, into genes that have demonstrated the ability to predict "bad biology, disease, and lung cancer," Berryman said.
Licensing technology from UCSF, he founded Pinpoint four years ago, and since then, the company has been sorting through the hundreds of genes that Jablons and his colleagues investigated in their research, and developing algorithms. Ultimately, the firm settled on 11 genes that provide quantitative data and three housekeeping genes for a total of 14 genes.
The test originally was slated to run on frozen tissue, but Berryman soon realized that in order for it to be commercially viable, it had to be used on formalin-fixed, paraffin-embedded tissue.
"So the first thing we did was to compare our RNA yields from paraffin tissue versus frozen, and fortunately for the genes we were looking for, that came out just great," Berryman said.
During the past year-and-a-half, Pinpoint has focused on clinically validating its panel. The results of that work are the basis of The Lancet article. In it, researchers were able to correlate patients grouped by the assay by their risk for recurrence with their chances for survival beyond five years.
Pinpoint and its collaborators at UCSF, Kaiser Permanente, and a number of institutions and universities in China found that among patients whom the assay identified as low-risk for recurrence, 71.4 percent were still alive after five years, and among patients it determined to be at intermediate risk for recurrence 58.3 percent survived beyond five years. Among high-risk patients, 49.2 percent survived beyond five years.
Based on those results, the authors said that Pinpoint's assay "reliably identified patients with early-stage non-squamous NSCLC at high risk for mortality after surgical resection," and it "provides prognostic differentiation of patients with early-stage disease and might be helpful in the identification of the most appropriate application of treatment guidelines to improve clinical outcomes."
According to the National Cancer Institute, more than 226,000 new cases of lung cancer will be diagnosed in the US this year. Of that number, between 15 percent and 20 percent are Pinpoint's initial market opportunity, Berryman said.
The assay lists for $3,995, but Pinpoint does not yet have any contracts with insurers or other payors for reimbursement for the test.
The company also plans to bring the test to Europe, which has a market similar to the US.
Further on, Berryman said that China would be a "tremendous" opportunity, because of its size and the high incidence of lung cancer in the country. According to the Globocan Project of the World Health Organization's International Agency for Research on Cancer, more than 522,000 cases of lung cancer were diagnosed in China in 2008 with nearly 453,000 deaths.
Berryman said that although Pinpoint is commercializing the lung cancer assay now, it could have launched it a year ago when its laboratory received CLIA certification. But it chose not to do so until it had "really strong data" around the assay.
One of the unique characteristics of The Lancet study, he said, is that it includes tumor samples from the China Clinical Trial Consortium. Aside from the Chinese market opportunity, inclusion of CCTC in the validation study also helps clear up one potential question about the effectiveness of the Pinpoint assay for a non-Caucasian population.
Genomic studies have largely concentrated on Caucasian populations, but in NSCLC, research has shown that EGFR mutations cause Chinese patients to respond differently than Caucasians to EGFR-targeted therapies such as Tarceva (erlotinib).
As a result, "we didn't really know what to expect," with the study, Berryman said, but "as it turned out there was virtually no difference in this prognostic" between the Chinese cohort and the non-Chinese cohort.
According to the study's authors, "the success of this assay in an ethnically distinct cohort might be among the strongest pieces of available evidence that fundamental genetic elements of non-squamous NSCLC biology exists that characterize this disease."
With the launch of the prognostic test underway, next in Pinpoint's pipeline is a predictive test for the effectiveness of different chemotherapies on individual NSCLC patients who have had surgery.
Pinpoint is also eyeing a prospective study that could provide greater validation of the Pinpoint Dx Lung Assay. That study, which would take several years to complete, would take a group of NSCLC patients who have had surgery, and run the Pinpoint assay on their tumor samples. Results from patients who have received chemotherapy would be compared to those who haven't, and low-risk patients would be compared to high-risk patients.
Since its founding, Pinpoint has been funded by Berryman and individual investors, and the company has never conducted a formal financing round, he said. Prior to founding the company, Berryman, a pharmacist by training, worked at Genentech, now part of Roche, on lung cancer research. It was there that he met Jablons.
Before that he was at Myriad Genetics, where he was on the commercial team that launched that firm's BRACAnalysis test.
Aside from Berryman, Mountain View, Calif.-based Pinpoint has one full-time employee in the laboratory and four part-time employees.