In recent weeks Freenome, Inc. (NASDAQ: FRNM) has gained two regulatory advances for its blood-based cancer tests.
The company just received FDA breakthrough device designation for its SimpleScreen Lung blood biopsy. The designation covers adults aged 50 to 80 with a smoking history of at least 20 pack-years who are not already having the recommended low-dose CT scans. The test uses DNA methylation, protein markers and a machine-learning system to spot early signs of lung cancer in a normal blood sample. A positive result means the patient should then have a low-dose CT scan.
Freenome is still running clinical studies on the tool, including the PROACT Lung trial, and has already shared early data that show the test works well across different stages and types of lung cancer. This step follows the FDA approval Freenome won last month for its SimpleScreen CRC test for bowel cancer, plus the deal that lets Abbott Laboratories (NYSE: ABT) (ETR: ABL) sell that test in the United States beginning this autumn.
Both tests use the same basic platform that looks at DNA methylation patterns in the blood and applies AI algorithms. The main differences are the people they target and the extra markers they use. The bowel cancer test is for average-risk adults aged 45 and over and mainly relies on methylation. The lung test is for higher-risk smokers, adds protein markers, and is meant to work alongside CT scans rather than replace them.
“We continue to advance the clinical work necessary to submit SimpleScreen Lung for FDA review,” said chief executive Aaron Elliott.
Top rivals in blood-based lung cancer testing include DELFI Diagnostics with its FirstLook Lung test, Grail Inc (NASDAQ: GRAL) (FRA: NL0) with its Galleri multi-cancer test, and Nodify test creator Biodesix Inc (NASDAQ: BDSX).
Read more: Breath Diagnostics advances pre-op pneumonia screening with FDA breakthrough designation
Freenome’s shares popped on public debut, then slid
Freenome began trading on Nasdaq under the ticker FRNM on Jul. 21 following the completion of its special purpose acquisition merger with Perceptive Capital Solutions Corp. Shares opened around US$11.69, surged to an intraday high near US$14.22 and closed the debut session at approximately US$13.01. Since then the stock has been volatile, pulling back in the subsequent weeks toward the low 10 dollar range before partially recovering.
By market close on Aug. 12, it stood at US$11.55, roughly 11 per cent below its first-day close, amid elevated trading volumes and mixed reactions to positive regulatory news such as the FDA approval of its SimpleScreen CRC test and the newest expedited review (breakthrough) status.
Freenome’s recent FDA clearances follow nods of approval for other notable influences in the lung cancer screening sector. Guardant Health Inc (NASDAQ: GH) (FRA: 5GH) secured FDA approval for its Guardant360 Liquid CDx blood test In May. Breath Diagnostics also attained the breakthrough certification for its lung cancer breath test’s pre-surgery pneumonia risk assessment capabilities in February.
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
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