Personalis Inc (NASDAQ:PSNL) shares climbed 9.3% on Tuesday after Medicare approved coverage for the company’s 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 cited clinical evidence produced through Personalis’ collaboration with the TRACERx consortium, which validated the NeXT Personal test’s ability to identify residual disease in lung cancer patients with high accuracy. The new lung cancer decision follows recent coverage for breast cancer, expanding access for Medicare beneficiaries to the company’s MRD testing.
Lung cancer remains the leading cause of cancer death in the United States, with roughly 230,000 new diagnoses each year. The NeXT Personal assay is configured to detect very small quantities of circulating tumor DNA (ctDNA) in the bloodstream that may signal cancer recurrence, in many cases before such recurrence is visible on standard imaging studies.
In a company statement, Chris Hall, Chief Executive Officer and President of Personalis, said: "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."
Technically, the NeXT Personal test utilizes whole-genome sequencing together with advanced noise-suppression methods to monitor up to approximately 1,800 mutations that form a unique molecular fingerprint of an individual patient’s tumor. That breadth of mutation tracking is intended to improve sensitivity, a key consideration in lung cancer where shedding of ctDNA can be low and therefore difficult to detect reliably.
The Medicare coverage decision is positioned to expand the number of beneficiaries who can access NeXT Personal for post-treatment surveillance of early- to mid-stage NSCLC. By increasing reimbursement access in this patient population, the decision may support broader clinical implementation of the assay where early detection of molecular recurrence could precede radiographic detection.
Details about any specific coverage parameters, limits or implementation timelines were not provided in the company statement. The clinical validation by the TRACERx collaboration and the prior breast cancer coverage form the evidentiary basis cited by Medicare for this surveillance indication.
Context and implications
The Medicare determination pertains specifically to surveillance in Stage I through Stage III NSCLC. The company’s technical approach - whole-genome sequencing and noise suppression - enables tracking of a large set of patient-specific mutations, which is particularly relevant to cancers that shed small amounts of ctDNA.