SAN DIEGO—Biocept Inc., a molecular oncology diagnostics company specializing in biomarker analysis of cell-free circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs), and Nashville, Tenn.-based Insight Genetics, a leading molecular diagnostic assay development company, are collaborating to generate an enhanced diagnostic for the expression and mutation of ALK, a major therapeutic target in the treatment of non-small cell lung cancer (NSCLC).
As part of the initial collaboration, Biocept and Insight Genetics will evaluate the combination of both companies’ platform technologies to enhance detection of ALK status in NSCLC patients. Biocept’s proprietary technology will be used to capture and analyze CTCs and ctDNA. Insight Genetics will then utilize its technical expertise and proprietary evaluation methods to determine ALK expression and whether the gene has mutated over the course of cancer treatment.
The initial aim of this collaboration is to better identify and monitor patients who may benefit from existing ALK-based therapies as well as those that may benefit from second-generation therapies based on inhibitor resistance mechanisms.
“ALK is incorporated into the testing guidelines for oncologists making treatment decisions in NSCLC patients,” notes Biocept’s Raaj Trivedi, vice president of commercial operations. “ALK-positive patients now have targeted treatment options with FDA-approved drugs: Pfizer’s Xalkori (crizotinib) and Novartis’s Zykadia (ceritinib).”
“We are finding that many patients are still not being tested to determine their ALK status due to a lack of biopsy tissue,” Trivedi adds. “This lack of information makes personalized treatment decisions—either to use FDA-approved ALK target drugs or to include an ALK-positive patient in a trial for second- and third-generation therapies—much more difficult.”
Part of Biocept’s business model is to help identify more patients for new and existing therapies using a simple, blood-based liquid biopsy when tissue biopsy is not available. Biocept currently offers an ALK rearrangement test using circulating tumor DNA found in a patient’s blood. “However, we are always looking for other technologies that will identify the full spectrum of patients who might qualify for existing therapies or therapeutic candidates,” Trivedi states. “Our hope is that by expanding our menu to include different methods of evaluating ALK status (such as ALK expression) we will be able to identify such patients.”
“We established this research collaboration with Insight Genetics to identify and validate these additional methods of determining ALK status—specifically, the ALK kinase domain by mRNA expression. Qiagen already offers this Insight Genetics mRNA test for tissue biopsies, so the logical next step was for our companies to work together to bring Insight’s tissue-based offering to a less invasive, blood-based platform using Biocept’s proprietary blood-based detection technology.”
“Biocept’s ability to perform a ‘liquid biopsy’ on these NSCLC patients by capturing and analyzing CTCs and ctDNA using a simple blood draw rather than relying on solid tumor biopsy gives us a distinct collaborative advantage with leading industry partners. We are excited to explore the potential of such an agreement with Insight Genetics, combining the power of our capture platform with Insight’s specific molecular testing content,” said Michael Nall, president and CEO of Biocept, in the news release about the deal.
“As the field of ALK-based therapies continues to grow with second- and third-generation molecules, the concept of looking at both DNA and RNA from CTCs is a diagnostic approach Insight has been interested in exploring for some time. Biocept, as a leader in CTC and ctDNA capture and analysis, is well positioned to help us pursue this diagnostic innovation,” added Dr. Stephan Morris, scientific founder and chief scientific officer of Insight Genetics.
“The ability to obtain information about a tumor through a simple, blood-based test is appealing in that it can not only qualify patients for targeted therapies, but also aid in the monitoring of these patients for changes in a tumor as disease progresses,” Morris continued. “By combining our existing expertise in ALK testing with Biocept’s liquid biopsy technologies, we are poised to expand our mutual efforts in profiling and monitoring ALK positive patients and mechanisms of resistance identified with this patient cohort.”
