From the Editor: Liquefaction, Dx Style

June 7, 2016

When technologies have matured to the point of market readiness, it can be hard to keep track of the many new products that suddenly become available to the marketplace. This spring, after many months of anticipation, early FDA approvals hint that the floodgates for so-called “liquid biopsy” technologies are about to be thrown wide open.

According to FDA, liquid biopsy technologies are advancing quickly. As a noninvasive method of detecting genetic alterations in tumors, analysis of circulating tumor cells (CTCs) and cell-free tumor DNA (cfDNA) in plasma holds great promise for improving cancer diagnosis and monitoring as well as drug development. The new technologies are being incorporated into numerous drug development programs and are likely to be rapidly incorporated into clinical care.

In April, FDA granted premarket approval for the Epi ProColon colorectal cancer screening test by Epigenomics AG, Berlin, Germany, making it the first blood-based circulating tumor DNA assay to receive agency approval. Interviewed for this month’s Inside Track column, Thomas Taapken, PhD, CEO and CFO of Epigenomics AG, observes that the company has discovered more than a dozen DNA methylation markers with diagnostic potential for other types of cancer. “Our most advanced product in active development is a test for the diagnosis of lung cancer, where we are using two DNA methylation gene marker signatures to diagnose lung cancer in the blood sample of a patient,” says Taapken.

But Epigenomics’ new products could face a market already filling with similar tests. At the beginning of this month, FDA approved the Cobas EGFR Mutation Test v2, by Roche Molecular Diagnostics, Pleasanton, Calif, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). The test is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations, which are present in 10% to 20% of non-small cell lung cancer (NSCLC). NSCLC may shed tumor DNA into a patient’s blood, making it possible to detect specific mutations in blood samples.

“Approvals of liquid biopsy tests make it possible to deliver highly individualized healthcare for patients,” says Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.”

And it’s not all about commercial tests—or even all about blood samples. At the end of May, Vigilant Biosciences Inc, Fort Lauderdale, Fla, announced the launch of its OncAlert Labs OraMark test, the first quantitative oral rinse test to accurately measure a tumor-initiating and stem-cell associated biomarker for oral cancer detection at its earliest stages. The test will be available to clinicians in the US as a laboratory-developed test beginning in the second half of 2016 exclusively through OncAlert Labs LLC, a CLIA-certified laboratory affiliated with Vigilant Biosciences.

OraMark is based on advanced patented technology, including an innovative methodology for measuring the tumor-initiating and stem-cell associated biomarker CD44 in combination with total protein, enabling earlier and more accurate detection of oral cancer—even potentially before visual indicators. The test provides highly actionable information pre- and post-biopsy, which complements visual examination and other tools used by head and neck specialists for detecting oral cancer to help optimize patient management and surveillance.

“The launch of OraMark is a major milestone for our company as it represents our first product available in the US, aiding clinicians with actionable information in the early detection of oral cancer with a quantitative oral rinse test,” says Matthew HJ Kim, founder, chairman, and CEO of Vigilant Biosciences.

To review progress in this rapidly developing field, FDA and the American Association for Cancer Research will cosponsor a public workshop, “Liquid Biopsies in Oncology Drug and Device Development,” at the Washington Convention Center, Washington, DC, on July 19, 2016. The workshop will provide a forum to discuss relevant scientific advances in the field of liquid biopsies in oncology and a regulatory environment that will support rapid translation of these emerging technologies into improved patient care. The workshop aims to:

  • Provide a state of the science overview of liquid biopsies in oncology.
  • Discuss the use of tumor-derived cfDNA in drug development and clinical use, focusing on the treatment of lung cancer as a case study.
  • Discuss current approaches to the validation of in vitro diagnostic devices (or tests).
  • Discuss with diverse stakeholders ways to accelerate development of these technologies to advance cancer care.

Additional information about the workshop, including instructions for registration, is available via the FDA Website.

Source: Clinical Lab Products

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