SAN DIEGO—Building on its portfolio of blood-based solutions, Biocept Inc., a molecular oncology diagnostics company, has launched its EGFR mutation detection testing method and introduced a blood-based liquid biopsy aimed at helping doctors identify which patients would benefit from certain non-small cell lung cancer (NSCLC) therapies.
Identifying specific mutations in patients with advanced NSCLC can provide them the opportunity to receive optimal targeted therapies known as tyrosine kinase inhibitors (TKIs), according to a March 10 Biocept news release. In the United States, there are two U.S. Food and Drug Administration (FDA)-approved TKI therapies for patients with specific EGFR mutations: Erlotinib, marketed as Tarceva by Genentech Inc., and Afatinib, marketed as Gilotrif by Boehringher Ingelheim GmbH.
“One of the biggest problems in treating non-small cell lung cancer is that some patients no longer have enough tissue to try the life-saving biopsy,” according to Raaj Trivedi, vice president of commercial operations for Biocept.
In fact, “at the time of recurrence or progression of non-small cell lung cancer, many patients may not have the option to have an assessment of EGFR mutation status because all of the original tissue biopsy material was consumed by the diagnostic testing conducted to identify the cancer,” Trivedi stated in a news release.
“In other cases, patients may be too sick to undergo a surgical biopsy,” Trivedi added. “For patient populations who are not candidates for tissue biopsy, there is a clear need for a test that enables physicians to better manage [patients’] cancer. [With the addition of EGFR mutation testing] to our NSCLC diagnostic capabilities, we believe we are addressing this unmet medical need by delivering diagnostic results that are comparable to those available through tissue biopsy from a simple blood test, without putting sick patients through the ordeal of a surgical biopsy.”
“In the near term, our test is more focused on patients that cannot get a biopsy or did get a biopsy, but then ran out of tissue due to other diagnostic tests,” Trivedi tells DDNews. “The current standard of care for detecting molecular markers is to obtain a tissue biopsy from the patient, but we know that this may not always be feasible.”
“Our liquid biopsy solution is not intended to replace a biopsy yet, but the science is certainly moving in that direction,” Trivedi notes. “This is especially true as newer therapies are coming to market which are based on re-biopsy of patients.”
About 85 percent of lung cancers are NSCLC, he points out, and EGFR gene mutations are present in the tumors of about 10 percent of NSCLC patients, with the majority of these gene mutations expressing EGFR in exon 19 deletions or exon 21 L858R substitutions.
Lung cancer rates still remain high for a number of reasons, Trivedi said. The death rates are high because most patients get diagnosed at such a late stage.
“There have been quite a few powerful and groundbreaking therapies developed for the treatment of NSCLC,” Trivedi says. “However, tissue biopsy is currently needed to qualify for the therapy. Our goal is to qualify more patients for targeted therapies. Many patients would be missed for these life-extending drugs if we only relied on tissue for testing.”
“We aim to continue to expand our diagnostic menu, not only in lung cancer but also in other cancer types such as colon and melanoma,” he adds. “Our ultimate goal is to continue to help ensure that cancer patients are identified [by molecular testing] for the right drug, but then to also use our technology to monitor patients over the course of therapy to help ensure that the drug is working. If it isn’t, then they can be re-stratified to the next treatment regimen.”
Dr. Veena Singh, senior medical director of Biocept, stated, “With existing FDA-approved drugs on the market, every lung cancer patient should have the opportunity to have their sample tested to potentially qualify and benefit from one of these targeted therapies.”
Lung cancer is the leading cause of cancer-related death among men and women. According to data from the National Cancer Institute in 2013, an estimated 228,190 Americans will be diagnosed with lung cancer, and 159,480 will die from the disease.
On March 9, as Biotech announced its financial results for the year ended Dec. 31, 2014, Michael W. Nall, president and CEO of Biocept, said in a press release, “Over the past year, we have aggressively expanded our business as we work to validate additional applications of our technology platform and enhance our revenue stream. Importantly, we recently launched our Selector platform, providing ctDNA analysis using a blood sample for non-small [cell] lung cancer patients, which significantly enhances our existing test menu.”