Personalis Inc. (NASDAQ:PSNL) received a favorable reimbursement decision that could make its cancer test available to more patients — and more likely to be paid for by Medicare.
The Centers for Medicare & Medicaid Services' Molecular Diagnostic Services Program expanded coverage for its NeXT Personal minimal residual disease test for breast cancer patients undergoing neoadjuvant therapy.
The new coverage determination applies to patients diagnosed with Stage II-III triple-negative breast cancer and HER2-positive breast cancer.
The decision allows clinicians to use the company's personalized circulating tumor DNA monitoring test to evaluate treatment response before surgery.
Fourth Medicare Milestone For NeXT Personal
The latest determination marks the fourth Medicare coverage milestone for NeXT Personal, according to the company.
Earlier coverage decisions focused on post-surgical recurrence surveillance, while the new expansion moves the test into active treatment monitoring during therapy.
Chris Hall, CEO of Personalis, said the coverage expansion advances the company's efforts to integrate its MRD technology into treatment management.
"Securing our fourth Medicare coverage decision for NeXT Personal is another milestone that moves our technology into active treatment management," Hall said.
Study Data Supported Coverage Expansion
Personalis said the coverage determination was supported by findings from the prospective PREDICT-DNA study, which was published in the Journal of Clinical Oncology.
The study tracked 227 patients with triple-negative and HER2-positive breast cancer across more than 24 U.S. cancer centers.
According to the company, the data showed that ultrasensitive ctDNA monitoring with NeXT Personal accurately tracked response to neoadjuvant therapy and performed better than traditional clinical metrics in predicting long-term outcomes.
A key finding from the study showed that nearly half of all ctDNA detections after neoadjuvant therapy occurred below 100 parts per million, levels that less sensitive MRD tests may fail to identify.
Focus On Ultrasensitive Detection
Richard Chen, president and chief medical officer at Personalis, said the findings highlighted the importance of highly sensitive testing in monitoring therapy response.
Chen said NeXT Personal can track up to roughly 1,800 patient-specific variants, which he said provides physicians with detailed insight into treatment response dynamics during neoadjuvant therapy.
PSNL Price Action: Personalis shares were up 9.30% at $7.69 at the time of publication on Wednesday, according to Benzinga Pro.
Over the past month, PSNL has gained about 17.8% versus a 4.3% rise in the S&P 500 and is down roughly 5% year-to-date compared to the index’s 7.8% gain.
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