Double-dose of CDx

In June, two companies made important announcements regarding new FDA-approved cancer diagnostics. The first comes from Cancer Genetics Inc. (CGI) with its launch of Thermo Fisher Scientific’s Oncomine Dx Target, the first next-generation sequencing (NGS)-based companion diagnostic (CDx) test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC). The second, from Illumina Inc., introduced the company’s Extended RAS Panel, a kit designed to be used on the Illumina MiSeqDx System, enabling laboratories to help clinicians identify which patients are eligible for treatment of metastatic colorectal cancer with Amgen Inc.’s Vectibix. Both of these new developments will help patients receive more accurate treatment by eliminating the need for multiple tests and identifying the most effective drug candidates.

Los Angeles-based CGI is one of only a handful of U.S. companies to offer Thermo Fisher’s Oncomine Dx Target Test, which was officially approved by the FDA on June 22 of this year. The test was designed to simultaneously evaluate 23 genes clinically associated with NSCLC, the results of which can be used by physicians to match patients with therapies in days rather than the weeks it can take testing one biomarker at a time. The test report will not only indicate whether patients have ROS1, EGFR and BRAF alterations linked to the three current FDA-approved treatments—AstraZeneca’s EGFR inhibitor Iressa (gefitinib), Pfizer’s ALK and ROS1 inhibitor Xalkori (crizotinib) and the combination therapy of Novartis’ MEK inhibitor Mekinist (trametinib) and RAF inhibitor Tafinlar (dabrafenib)—but also the presence or absence of gene variants in 20 other genes associated with NSCLC that are currently investigated in clinical trials and potentially actionable in the future.

The Oncomine Dx Target Test is a kit and requires as little as 10 nanograms of DNA from formalin-fixed, paraffin-embedded (FFPE) tissues samples. This is a significant advantage given the challenge of NSCLC patient samples often being of limited quantity. All tests will be run on Thermo Fisher’s Ion PGM Dx System, which received FDA 510(k) clearance in parallel for use on FFPE tissue samples. CGI, which has been recognized as Thermo Fisher’s NGS CDx Center of Excellence, is among the first three laboratories that will offer the Oncomine Dx Target Test as a service to oncologists.

Dr. Shereen Gheith, chief of molecular pathology and hematopathology at Health Network Laboratories, stated: “The Oncomine Dx Target Test is an important new capability for the global medical community and another significant step in the growth of CGI as an extremely qualified resource for the management of cancer patients nationwide. CGI’s 21^st century molecular technologies, speed and world-class medical environment bring increased hope to cancer patients for improved outcomes.”

Lung cancer is by far the leading cause of cancer death among both men and women, causing approximately one in four deaths from cancer, and is the second most commonly diagnosed for of cancer in both men and women, with the exclusion of skin cancer. About 14 percent of all new cancers are lung cancers, with NSCLC accounting for 85 percent of all lung cancers. It is estimated that in 2017, approximately 222,500 Americans alone will be diagnosed with lung cancer, and almost 156,000 will die from this disease.

“We are very pleased to be able to add the Oncomine Dx Target Test to our comprehensive menu of cutting edge diagnostic services available to physicians. NGS has revolutionized cancer research by providing a comprehensive method of detecting genomic alterations associated with somatic cancer. By becoming a companion test, the Oncomine Dx Target Test represents an important advance in precision medicine as a rapid and comprehensive tool guiding clinicians in treatment decision-making,” said CGI President and CEO Panna Sharma.

According to Thermo Fisher, this initial approval will enable the company to work quickly to expand the test’s indications into new drug/biomarker combinations, including applications beyond lung cancer.

Illumina, which is based in San Diego, also hopes to streamline patient care with its development of the Extended RAS Panel.

“As we expand our understanding of the genomic drivers of cancer, next-generation sequencing has the potential to transform cancer therapeutics by informing development of targeted therapies and by delivering integrated testing platforms to identify the right therapy for the right patient,” said Francis deSouza, the company’s president and CEO. “As our first companion diagnostic and PMA [pre-market application] approval in oncology, the Extended RAS Panel paves the way for broader-based genomics solutions and brings us closer to realizing the promise of next-generation sequencing in the treatment of patients with cancer.”

As the first monoclonal anti-epidermal growth factor receptor (EGFR) antibody approved by the FDA for use in combination with FOLFOX for first-line treatment for patients with wild-type RAS metastatic colorectal cancer (mCRC), Vectibix provides patients with new options for treatment. The Extended RAS Panel is capable of simultaneously detecting 56 RAS mutations contraindicated for anti-EGFR therapy and is expected to be available towards the end of this year.

“Together with Amgen, we’ve developed a companion diagnostic test kit that interrogates 56 variants across the KRAS and NRAS genes in order to establish mutant status in a single test. Through the Extended RAS Panel, clinicians will be able to identify patients with wild-type RAS genes who may benefit from treatment with Vectibix,” shared Dr. Garret Hampton, executive vice president of clinical genomics at Illumina. “This approval demonstrates Illumina’s ability to bring NGS to clinical diagnostics through the FDA PMA process. The Extended RAS Panel on the MiSeqDx System enables labs to implement an in-house solution for precision oncology and signifies that NGS has reached a milestone as a clinical diagnostic platform to aid therapeutic decision-making in oncology.”