Personalis Inc (NASDAQ: PSNL) (FRA: 04X) climbed by approximately 10 per cent on the Nasdaq on Tuesday following the announcement of Medicare coverage for its innovative blood biopsy test.
The movement reflects investor enthusiasm over expanded access to the test for Medicare beneficiaries. They account for more than half of lung cancer patients in the United States, roughly.
This market reaction highlights potential revenue growth from expanded reimbursement and builds upon recent approvals for the diagnostics tool in breast cancer analysis.
Personalis’s ‘NeXT Personal’ test has been authorized for Medicare coverage in monitoring patients with non-small cell lung cancer (NSCLC) in stages one to three.
The blood draw is an ultrasensitive molecular residual disease (MRD) assay (highly sensitive lab test) tailored to identify trace quantities of circulating tumour DNA in a person’s blood. The amount shed by NSCLC is often quite low.
“What a win for lung cancer patients,” stated Director of Product Management, Dan N., “a true ultrasensitive MRD test to help manage patient care in a poor ctDNA shedding cancer type.”
This type of liquid biopsy is particularly useful for early detection of relapse or recurring cancer among lung cancer survivors, often identifying disease months before standard imaging scans could. It enables health professionals to intervene quickly, potentially improving treatment outcomes.
What sets NeXT Personal apart from other MRD tests available is its superior rate of sensitivity. It achieves detection limits as low as 1 part per million of ctDNA and tracks up to 1,800 patient-specific tumour mutations.
This extreme sensitivity enables the blood draw to pinpoint very low levels of ctDNA that other tools may miss. It has a 96 per cent specificity rate for reducing false positives.
Natera Inc (NASDAQ: NTRA) (FRA: 45E), Exact Sciences Corp (NASDAQ: EXAS) (FRA: EXK), Adaptive Biotechnologies Corp (NASDAQ: ADPT) (FRA: 1HM) and Guardant Health Inc (NASDAQ: GH) (FRA: 5GH) are notable competitors pushing forward with differing variations of liquid biopsies.
Meanwhile, emerging innovators are also expanding the field. Breath Diagnostics, for instance, has been utilizing its OneBreath platform to analyze volatile organic compounds in a single exhaled breath for early lung cancer detection. This variety of diagnostics could offer a more non-invasive means of complementing ctDNA assays should the device become more widely adopted in the healthcare sector. OneBreath has demonstrated 94 per cent sensitivity and 85 per cent specificity in clinical studies.
Read more: Prestigious medtech intelligence firm recognizes Breath Diagnostics for innovation
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