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

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

Darmstadt, September 4th

NEWS

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 CFO Hendrik Krämer-Sohns. ‘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

PRESS CONTACT

Anette Ludwig
Zyagnum AG
Gräfenhäuser Str. 26
64293 Darmstadt
Tel. +49 173 769 68 22
E-Mail: presse@zyagnum.com

About Zyagnum: The Darmstadt-based biotechnology company Zyagnum AG develops diagnostic solutions for human medicine. Zyagnum has a profound understanding of immunological processes and their connection with diseases. For example, the EDIM® technology developed by Zyagnum can be used in blood tests to detect specific antigens in immune cells that may play a role in tumour development. Today, the company employs more than 50 people and was founded by Zyagnum CEO Ralf Schierl together with Johannes Coy in 2007. 

About EDIM®: When the human organism derails and runs towards disease, the immune system is often the first to recognise this, often before any symptoms. The platform technology we have developed, EDIM® (Epitope Detection in Monocytes), uses the mechanisms of the immune system to detect such derailments. The EDIM® technology examines macrophages for antigens that have previously been taken up into the cell interior by these immune cells through phagocytosis – this is why we also call EDIM® an immunological biopsy.

About PanTum Detect®: PanTum Detect® is a cancer screening blood test for the early detection of tumors. By means of a simple blood sample, it can provide indications of almost all cancer types in early, symptom-free stages – even for tumor types for which there are currently no established statutory early detection examinations. PanTum Detect® is based on EDIM® technology and detects the enzymes TKTL1 and DNaseX (Apo10), which both are increasingly produced in many tumors. PanTum Detect® does not diagnose cancer but provides indications of a potential cancer to be localized and confirmed in follow-up examinations (e.g. by imaging procedures such as MRI or PET/CT and histopathological procedures). PanTum Detect® has a sensitivity of 95.2% and a specificity of 99.5%.

 

*All cancers that form solid tumors (“solid cancers”). “Solid cancers” refers to tumors that grow as solid masses in an organ or tissue. Solid tumors are distinct from hematologic cancers, such as leukemia and lymphoma, which arise in cells of the blood or lymphatic system and do not form solid tumor masses.