Circulogene Expands Liquid Biopsy Testing Capabilities, Supporting Personalized Treatment for Lung Cancer Patients

Circulogene Theranostics has announced the addition of three new cfRNA-based tests to its liquid biopsy testing capabilities. The new cfRNA additions include testing for ALK and ROS1 gene fusions and PD-L1 expression – associated with non-small cell lung cancer (NSCLC) – enabling actionable, targeted NSCLC treatment.

Lung cancer is one of the most common cancers and the leading cause of cancer death in the U.S. and worldwide, with NSCLC accounting for the majority of cases according to the American Cancer Society and global cancer statistics. Circulogene’s ALK and ROS1 tests cover more than 90 percent of clinically relevant gene fusions associated with treatment decision-making for targeted therapy (crizotinib, ceritinib and brigatinib) for NSCLC patients.

“Only a handful liquid biopsy companies can offer both cfDNA- and cfRNA-based CLIA-validated tests, and even fewer can deploy both NGS and real-time PCR platforms,” said Circulogene Chief Operating Officer Scott Rezek. “We now have the capability to develop, validate and commercialize the complete spectrum of liquid biopsy molecular diagnostics to the medical and scientific community.”

Non-invasive liquid biopsies represent a major advance over traditional surgical tumor biopsies, which are costly, time consuming and only sample a small portion of tumor tissue, leading to a high failure rate. Multiple surgical biopsies are also not practical, particularly with NSCLC. Liquid biopsy patients benefit from improved outcomes, and molecular testing of NSCLC is now widely recommended by oncology societies.

Circulogene’s extraction-free, proprietary cell-free nucleic acid enrichment capabilities result in near-full recovery of genetic material from droplet volumes of blood, collecting more than 100 times more cfDNA/cfRNA with just 1/10 of the blood (as little as 20 microliters) compared to the current industry standard for non-invasive liquid biopsy testing. Furthermore, unlike other laboratories, Circulogene requires only a single blood sample tube for both the DNA and RNA tests.

Once cancer has been diagnosed in a patient, Circulogene’s laboratory can report testing results back to physicians in a matter of days to aid them in selecting the right therapy at the right time for each patient’s unique situation. Circulogene’s cfRNA-based testing results can be reported within one week.

“The ability to identify and track actionable cancer mutations is leading to a major shift in the molecular diagnosis and treatment of lung and other cancers,” said Circulogene Chief Scientific Officer ChenHsiung Yeh, Ph.D. “Liquid biopsy, tumor-specific cfDNA and cfRNA detection offers significant benefits over conventional protein biomarkers and imaging technology. As therapies targeting ALK and ROS1 gene fusions and PD-L1 expression expand, the accurate, timely and cost-efficient detection of these biomarkers will be critical in delivering optimal treatment to NSCLC cancer patients.”

Circulogene is the first and only biotechnology company able to enrich circulating cell-free DNA from blood-drop volumes for patient-specific monitoring of cancer, achieving maximal output from minimal input. The company’s liquid biopsy testing is capable of detecting nearly 3000 cancer mutations on 50 well-established cancer-associated genes for its 14 cancer profiles. Circulogene currently provides testing for breast, colorectal, lung, gastric, gastrointestinal stromal (GIST), hematological, melanoma, ovarian, pancreatic, gall bladder, bladder, prostate, head and neck, and thyroid cancers.