The NeXT Personal molecular residual disease test can now be used for surveillance of patients with Stage I to III non-small cell lung cancer.
Personalis Inc announced Medicare coverage for its NeXT Personal molecular residual disease (MRD) test for surveillance of patients with Stage I to III non-small cell lung cancer (NSCLC).
The coverage determination is based on clinical evidence from the company’s collaboration with the TRACERx (TRAcking Cancer Evolution through therapy [Rx]) consortium. Data from the longitudinal study, published in Cell, demonstrated NeXT Personal’s ability to identify residual disease with high accuracy in lung cancer patients.
Lung cancer remains the leading cause of cancer death in the US, with an estimated 230,000 new cases diagnosed annually. For patients with Stage I-III NSCLC, the risk of recurrence remains a primary clinical concern.
NeXT Personal is designed to detect trace amounts of circulating tumor DNA (ctDNA) that can indicate the presence of cancer, often before the cancer appears on standard imaging scans.
“Securing Medicare coverage for lung cancer surveillance is a big step forward on two fronts: it broadens patient access to NeXT Personal for one of the most common cancers in the US, and it is a catalyst for our continuing growth,” says Chris Hall, chief executive officer and president of Personalis, in a release. “For the first time, Medicare beneficiaries battling lung cancer will have access to ultrasensitive MRD testing, providing the deep insights needed to manage their care with greater confidence.”
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NeXT Personal leverages whole-genome sequencing and noise-suppression technology to achieve ultrasensitivity by tracking up to 1800 mutations that represent a unique fingerprint of a patient’s tumor. The test provides clinicians with a recurrence and residual disease monitoring tool in lung cancer, where shedding of ctDNA can be low and difficult to detect, according to a release from the company.
The Medicare coverage for lung cancer surveillance follows recent approval for breast cancer, expanding access to Medicare patients across multiple cancer types.
“Lung cancer survivors often live with enormous uncertainty, with worry about recurrence,” says Dr Richard Chen, chief medical officer and executive vice president of R&D at Personalis, in a release. “This coverage decision helps cancer patients and physicians get access to the NeXT Personal test, which can help them navigate the uncertainty in their cancer journey.”
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