Shares of Personalis, Inc. (Nasdaq: PSNL) rose sharply Tuesday following the company’s announcement that Medicare will now cover its NeXT Personal test for surveillance of patients with Stage I to III non-little cell lung cancer (NSCLC).
The Medicare coverage decision, supported by data from the TRACERx (TRAcking Cancer Evolution through therapy (Rx)) consortium, expands access to the molecular residual disease (MRD) test for Medicare beneficiaries. NeXT Personal is designed to detect trace amounts of circulating tumor DNA (ctDNA) which can indicate the presence of cancer before it is detectable through standard imaging, according to the company.
Lung cancer remains the leading cause of cancer death in the United States, with approximately 230,000 new cases diagnosed each year. The risk of recurrence is a significant concern for patients diagnosed with Stage I-III NSCLC. The NeXT Personal test aims to address this by providing an ultrasensitive method for monitoring for residual disease.
“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,” said Chris Hall, Chief Executive Officer and President of Personalis.
This coverage follows recent Medicare approval for the NeXT Personal test in Stage II and III breast cancer surveillance, further establishing the test’s clinical utility and expanding its potential patient base. The clinical performance of NeXT Personal in lung cancer was validated by data recently published in the journal Cell.
