First blood test for early cancer detection receives FDA approval in the USA

The US Food and Drug Administration (FDA) has approved the Shield blood test from US biotechnology company Guardant Health as a primary screening option for colorectal cancer. This makes Shield the first blood test for use in early cancer detection to receive this important approval in the USA.

The future of cancer screening – “An important step in early cancer detection”

“It is undoubtedly another important step in the early detection of cancer,” says Zyagnum CEO Hendrik Krämer. ‘Blood tests that can provide early indications of cancer are the future of cancer screening. The fact that Guardant Health has received approval shows that we have come a big step closer to this future.’

Shield is also the first approved blood test for cancer screening that fulfils the requirements for reimbursement by Medicare. Medicare is the federal public health insurance scheme within the US healthcare system for people over 65 or with disabilities.

Supplement, not a substitute for existing colorectal cancer screening

The test complements other methods of colorectal cancer screening, including colonoscopies and at-home stool tests. A simple blood test may be more convenient for some patients, while colonoscopies may be perceived as invasive or home faecal tests as uncomfortable.

‘The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,’ Dr Daniel Chung, a gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in a statement published by Guardant Health.

‘The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible,’ Chung said. ‘With increasing screening rates and early cancer detection, many lives can be saved.’

Shield focus on colorectal cancer – PanTum Detect® for numerous types of cancer  

However, it is also true that the Shield test can ‘only’ provide indications of bowel cancer, which must then be clarified in follow-up examinations. It is not suitable for the early detection of other types of cancer.

‘In the long term, it cannot be the best solution to establish a separate cancer screening programme for each type of cancer. This would simply result in too many examinations. This holds true even if we talk about separate blood tests for separate types of cancer. Ultimately, we need one practicable and easy-to-use screening procedure for all types of cancer,’ says Zyagnum AG CEO Ralf Schierl.

PanTum Detect® from Zyagnum AG has been authorised in the EU since 2017 and can provide early indications of numerous types of cancer. It is already in widespread use and is available in Germany via the supplementary insurance “Krebs-Scan” from the HanseMerkur Insurance Group.

Click here for the Guardant Health press release:

July 29, 2024: Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening