US-based precision oncology firm Guardant Health has submitted the final module of the premarket approval (PMA) application for its Shield blood test, which screens for colorectal cancer (CRC), to the US Food and Drug Administration (FDA).
The Shield test has been designed to detect the signals of CRC from DNA in the bloodstream, known as circulating tumour DNA (ctDNA), that is shed from tumours.
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The laboratory-developed test (LDT) is intended to identify the specific DNA characteristics that may help in indicating the presence of CRC.
The PMA filing includes data from the prospective registrational ECLIPSE study, which was conducted with more than 20,000 average-risk adults, aged between 45 and 84 years, across the US.
The trial was designed to assess the performance of the company’s blood test in detecting CRC signs compared to a screening colonoscopy.
In the preliminary results, the study showed that the Shield test achieved 83% sensitivity and 90% specificity in detection of the disease.
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By GlobalDataGuardant Health co-CEO AmirAli Talasaz said: “Completing our FDA PMA application for Shield is a significant step forward toward our mission of saving millions of life-years through accessible blood-based cancer screening. We are looking forward to partnering with the agency on bringing this life-saving test to the market.
“Colorectal cancer is the second leading cause of cancer-related death, yet one in three eligible adults are not up to date with screening.
“Patient access to blood-based screening can help overcome barriers to traditional screening modalities, especially in underserved populations.”
In January, the company secured US FDA approval for the use of its Guardant360CDx liquid biopsy test as a companion diagnostic (CDx) for ORSERDU (elacestrant).
