Dive Brief:

• FDA has granted breakthrough device designation for Natera's test to detect and quantify circulating tumor DNA (ctDNA) after surgery in the blood of patients already diagnosed with some types of cancer and combined with certain drugs, Natera said Monday.
• Natera said its Signatera assay is the first ctDNA test that can be customized based on the unique mutations in a patient's tumor.
• Clinical studies have shown the test can identify molecular residual disease in non-small cell lung, bladder, breast and colorectal cancers up to two years earlier than standard imaging, the San Carlos, California-based company said.

Dive Insight:

Circulating tumor DNA (ctDNA) is found in the bloodstream when dying tumor cells release small pieces of their DNA. After blood is drawn from the patient, the ctDNA is extracted for molecular genomic analysis in a process sometimes referred to as a "liquid biopsy." The tests are being developed as a less-invasive diagnostic alternative to tissue biopsies, to improve treatment selection for late-stage cancers and for post-cancer monitoring.

Detection of ctDNA in patients with recurrent cancer may precede radiographic detection by more than six months, facilitating earlier treatment, researchers reported in JAMA.

There are applications for the Signatera test in patients who have already been diagnosed with cancer, Natera said. The company's studies have shown the Signatera test to be a significant predictor of long-term patient outcomes after surgery and treatment relative to other clinical and pathological factors, Natera said.

Natera said the FDA breakthrough designation will help support the company's commercialization strategy by speeding assessment and review of Signatera as an in vitro diagnostic for use in pharmaceutical trials. The company said it sees the test being used in the patient selection process among other study functions.

The FDA designation is an important step that "directly supports our stated goal of achieving $40 to $50 million in cumulative pharma contracts by the end of 2019," Solomon Moshkevich, general manager for the company's oncology and transplant businesses, said.

Cowen analysts, in a note to clients, said the development supports the firm's view that Natera can meet its financial targets for the Signatera test. "We have been told that the designation was achieved in conjunction with a yet-to-be disclosed large pharmaceutical partner pursuant to approval of a drug in a yet-to-be disclosed indication," the analysts wrote.