US FDA grants breakthrough device designation to multi-cancer detecting blood test

USA — The US Food and Drug Administration (FDA) has granted breakthrough device designation to OverC, a multi-cancer detection blood test (MCDBT), according to a press release from developer Burning Rock.

OverC is intended for use in detecting several types of cancer, including esophageal cancer, liver cancer, lung cancer, ovarian cancer, and pancreatic cancer, in a population of adult patients between the ages of 50 years to 75 years.

The company noted that OverC demonstrated a sensitivity of 69.1% and a specificity of 98.9%, according to data from the case-controlled THUNDER study.

The test is set to be further evaluated in prospective interventional studies in an asymptomatic population of patients.

Detection of disease as determined via the OverC test using the top 1 or 2 predicted tissues originating from cancer-associated signals could be indicative of cancer and should be followed by a diagnostic test, as suggested by a qualified health professional.

In the case of a negative test, cancer should still not be ruled out and a guideline-recommended standard screening test should be implemented.

“For cancer, early diagnosis and treatment are the key to the long-term survival of patients,” Yusheng Han, founder and CEO of Burning Rock, said in a press release.

Detecting cancer early before it spreads throughout the body can be lifesaving, and this is the promise of multicancer early detection tests (MCEDs).

Last year, President Joe Biden identified developing MCED tests as a priority for the Cancer Moonshot, a US$1.8 billion federal effort to reduce the cancer death rate and improve the quality of life of cancer survivors and those living with cancer.

MCED tests use DNA methylation patterns to identify the type of cancer and its origin site. DNA methylation is a natural modification of DNA that varies by tissue type, and cancer cells have abnormal methylation patterns that distinguish them from normal tissue.

There are currently several MCED tests in development and in clinical trials. In 2021, GRAIL launched the first commercially available MCED test in the US. This test, called Galleri, can detect over 50 types of cancer.

Other companies, like Exact Sciences, Freenome, and Singlera Genomics, are also developing MCED tests. These tests use different methods, such as looking for cancer-related proteins in blood, in addition to examining circulating tumor DNA.

Currently, MCED tests are not covered by insurance and can be expensive, costing US$949 for GRAIL’s test.

There is a bill being considered in Congress to provide Medicare coverage for FDA-approved MCED tests, showing the importance and demand for these tests.

“Liquid biopsy-based early detection technology will be an important supplement to the current cancer screening methods, especially for ovarian cancer, pancreatic cancer and other cancers that have no effective screening methods up to now,” Yusheng noted.

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