Guardant Health Inc (NASDAQ: GH) (FRA: 5GH) just secured another regulatory win for its oncology portfolio.
On May 20, the company won FDA approval for its Guardant360 Liquid CDx blood test. Shares rose by over 17 per cent during Thursday trading on the back of the news.
The test checks a patient’s blood for signs of cancer. Doctors use it to profile tumours in detail and find changes in genes that help pick the right treatments for people with advanced cancers. This latest version of the liquid biopsy looks at over 740 genes — 100 times more than the old version. It combines info on genes and other signals from the disease, thereby giving doctors a fuller picture from one simple blood draw.
The FDA has given its assent to the diagnostic tool because it helps healthcare professionals make better treatment choices with patients. Results come back fast, often in only seven days.
“Another proof point that liquid biopsy is no longer the future of oncology,” said Divya Mehta, Guardant’s Vice President, Commercial in the AMEA region, “it is the standard being built in real time shaping the way cancer is detected and treated.”
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
Approval builds on success with ‘Shield’
This new win adds to Guardant’s recent successes with a multi-cancer detection blood draw.
In June last year, the FDA gave Breakthrough Device Designation to the medtech company’s Shield tool. This step has sped up the agency’s review process for a test that aims to catch many different cancers early.
Shield already had success with its earlier colorectal cancer version approved in 2024. Many patients now choose the easy blood test instead of a colonoscopy.
Guardant recently won a Oncology Product Innovation of the Year award for Shield at the Healthcare Asia Medtech Awards in Singapore. The screening method is capable of detecting 10 different types of cancer with considerable accuracy.
FDA endorses other cancer screening systems
Guardant is not alone in impressing the FDA with screening device innovation.
Another American company, Breath Diagnostics, recently attained FDA Breakthrough Device Designation for its OneBreath platform to help assess risk of postoperative pneumonia in patients before cardiac surgery.
This diagnostics system was originally designed for detecting early-stage lung cancer in exhaled breath, and it has now proven its value for other indications as well. The designation speeds up review for this breath-based test that analyzes volatile organic compounds.
Additionally, Natera Inc (NASDAQ: NTRA) just made significant progress with its Signatera test. This month, the FDA approved Signatera CDx as a companion diagnostic in muscle-invasive bladder cancer. It helps doctors to find trace quantities of cancer left in the body after treatment and decide on next steps.
These approvals demonstrate the progression of impactful blood and breath tests for various cancers.
Read more: Breath Diagnostics advances pre-op pneumonia screening with FDA breakthrough designation
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