Medicare Expands MRD Testing Coverage for TNBC and HER2+ Cancer Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 20 2026
0mins
Source: Newsfilter
- Coverage Expansion: The Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for Personalis' NeXT Personal minimal residual disease (MRD) test, enabling monitoring of treatment response in Stage II-III Triple-Negative Breast Cancer (TNBC) and HER2-positive patients, marking the company's fourth Medicare coverage milestone in breast cancer.
- Clinical Evidence Support: This decision is backed by the PREDICT-DNA study published in the Journal of Clinical Oncology, which tracked 227 patients with TNBC and HER2+ breast cancer across 24 leading US cancer centers, demonstrating that NeXT Personal's ultrasensitive ctDNA monitoring outperforms traditional clinical metrics in predicting long-term patient outcomes.
- Significant Technical Advantage: The study revealed that nearly half of all ctDNA detections post-neoadjuvant therapy occurred at levels below 100 parts per million (PPM), while NeXT Personal can track up to approximately 1,800 patient-specific variants, providing the high resolution needed for physicians to accurately monitor treatment responses.
- Strategic Implications: Personalis CEO Chris Hall stated that this coverage expansion moves their technology into active treatment management, aiming to improve clinical outcomes for patients through their ultrasensitive MRD technology, further advancing the transformation of cancer care through personalized testing.
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Analyst Views on PSNL
Wall Street analysts forecast PSNL stock price to rise
7 Analyst Rating
6 Buy
1 Hold
0 Sell
Strong Buy
Current: 10.980
Low
10.00
Averages
11.17
High
12.00
Current: 10.980
Low
10.00
Averages
11.17
High
12.00
About PSNL
Personalis, Inc. is engaged in developing, marketing and selling advanced cancer genomic tests and analytics. The Company’s advanced genomic sequencing and analytics support the development of personalized cancer vaccines and other cancer immunotherapies. Its products include NeXT Personal, ImmunoI DNeXT, NeXT Personal Dx, NeXT Dx, whole exome sequencing (WES), and whole genome sequencing (WGS). NeXT Personal is a tumor-informed liquid biopsy test for the detection of minimal residual disease (MRD) and recurrence in cancer. NeXT Dx is a comprehensive tumor profiling test that is used to help select therapy for a cancer patient and identify potential clinical trials for a patient. The Company performed WGS on human samples for research projects, such as population sequencing initiatives. The Company’s tests and analytics are used by pharmaceutical companies for translational research, biomarker discovery, and the development of personalized cancer therapies.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Weak Individual Stocks: Within the ETF, Atlas Energy Solutions shares fell about 6%, while Flowco Holdings dropped approximately 4.7%, reflecting poor market performance for these companies that may lead investors to reassess their portfolios.
- Market Sentiment Impact: The overall weak performance of the oil and gas sector may cause investors to adopt a cautious stance towards related stocks, potentially affecting capital inflows into the industry.
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- Clinical Application Expansion: The latest determination by the U.S. Centers for Medicare & Medicaid Services will expand NeXT Personal's clinical use to include stage II and III triple-negative breast cancer or HER2-positive breast cancer patients, enhancing its competitive edge in cancer monitoring.
- Reimbursement Policy Change: This decision allows Medicare beneficiaries to receive reimbursement for NeXT Personal's use in monitoring treatment response to neoadjuvant therapy, marking a coverage expansion following Medicare's previous determination for recurrence monitoring after surgery, further solidifying its market position.
- Future Performance Outlook: Personalis targets a clinical volume of 43,000 to 45,000 tests for 2026 while reaffirming its revenue guidance of $78 million to $80 million, demonstrating the company's confidence in future growth.
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- Clinical Evidence Support: This decision is backed by the PREDICT-DNA study published in the Journal of Clinical Oncology, which tracked 227 patients with TNBC and HER2+ breast cancer across 24 leading US cancer centers, demonstrating that NeXT Personal's ultrasensitive ctDNA monitoring outperforms traditional clinical metrics in predicting long-term patient outcomes.
- Significant Technical Advantage: The study revealed that nearly half of all ctDNA detections post-neoadjuvant therapy occurred at levels below 100 parts per million (PPM), while NeXT Personal can track up to approximately 1,800 patient-specific variants, providing the high resolution needed for physicians to accurately monitor treatment responses.
- Strategic Implications: Personalis CEO Chris Hall stated that this coverage expansion moves their technology into active treatment management, aiming to improve clinical outcomes for patients through their ultrasensitive MRD technology, further advancing the transformation of cancer care through personalized testing.
See More
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- Clinical Evidence Support: Landmark clinical studies conducted in collaboration with the Vall d'Hebron Institute of Oncology (VHIO) demonstrate that NeXT Personal's ultrasensitivity enables real-time evaluation of treatment responses in immunotherapy, optimizing therapeutic pathways and minimizing unnecessary toxicity.
- Patient Benefits: With hundreds of thousands of patients receiving immunotherapy annually in the U.S., the new MRD test will assist physicians in accurately identifying responders and non-responders, thereby enhancing treatment efficacy and reducing costs, ultimately improving patient quality of life.
- Technological Advantage: NeXT Personal employs whole-genome sequencing and advanced noise-suppression technology to achieve sensitivity down to 1 part per million (PPM), providing a high-resolution view of a patient's unique tumor profile, which aids physicians in making more precise treatment decisions in ambiguous imaging scenarios.
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- Weak Individual Stocks: Within the ETF, Atlas Energy Solutions shares fell about 6%, while Flowco Holdings dropped approximately 4.7%, reflecting poor market performance for these companies that may lead investors to reassess their portfolios.
- Market Sentiment Impact: The overall weak performance of the oil and gas sector may cause investors to adopt a cautious stance towards related stocks, potentially affecting capital inflows into the industry.
- Uncertain Industry Outlook: Given the current economic environment, the oil and gas equipment and services sector faces challenges that could suppress the ETF's long-term performance, prompting investors to monitor industry developments for informed decision-making.
See More
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- Medicare Decision Impact: Personalis (PSNL) shares rose approximately 5% in premarket trading on Wednesday after the company received its fourth Medicare decision, which broadens coverage for its NeXT Personal minimal residual disease test in the U.S., likely boosting market demand significantly.
- Clinical Application Expansion: The latest determination by the U.S. Centers for Medicare & Medicaid Services will expand NeXT Personal's clinical use to include stage II and III triple-negative breast cancer or HER2-positive breast cancer patients, enhancing its competitive edge in cancer monitoring.
- Reimbursement Policy Change: This decision allows Medicare beneficiaries to receive reimbursement for NeXT Personal's use in monitoring treatment response to neoadjuvant therapy, marking a coverage expansion following Medicare's previous determination for recurrence monitoring after surgery, further solidifying its market position.
- Future Performance Outlook: Personalis targets a clinical volume of 43,000 to 45,000 tests for 2026 while reaffirming its revenue guidance of $78 million to $80 million, demonstrating the company's confidence in future growth.
See More
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- Coverage Expansion: The Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for Personalis' NeXT Personal minimal residual disease (MRD) test, enabling monitoring of treatment response in Stage II-III Triple-Negative Breast Cancer (TNBC) and HER2-positive patients, marking the company's fourth Medicare coverage milestone in breast cancer.
- Clinical Evidence Support: This decision is backed by the PREDICT-DNA study published in the Journal of Clinical Oncology, which tracked 227 patients with TNBC and HER2+ breast cancer across 24 leading US cancer centers, demonstrating that NeXT Personal's ultrasensitive ctDNA monitoring outperforms traditional clinical metrics in predicting long-term patient outcomes.
- Significant Technical Advantage: The study revealed that nearly half of all ctDNA detections post-neoadjuvant therapy occurred at levels below 100 parts per million (PPM), while NeXT Personal can track up to approximately 1,800 patient-specific variants, providing the high resolution needed for physicians to accurately monitor treatment responses.
- Strategic Implications: Personalis CEO Chris Hall stated that this coverage expansion moves their technology into active treatment management, aiming to improve clinical outcomes for patients through their ultrasensitive MRD technology, further advancing the transformation of cancer care through personalized testing.
See More
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- Healthcare Sector Recovery: On Wednesday afternoon, the NYSE Healthcare Index rose by 0.8%, indicating a gradual restoration of investor confidence in the healthcare sector, likely driven by an overall improvement in market sentiment.
- Market Rebound Signs: The increase in healthcare stocks suggests that despite economic uncertainties, investors remain optimistic about the long-term growth potential of the healthcare industry, particularly in areas like drug development and medical technology innovation.
- Increased Investor Attention: As the healthcare sector continues to evolve, heightened investor interest may lead to increased capital inflows into this area, further driving stock prices upward.
- Optimistic Industry Outlook: The growth potential of the healthcare sector is attracting more investor attention, especially against the backdrop of rising global health demands, with expectations for increased investments to support innovation and expansion in the future.
See More
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- Medicare Coverage Expansion: The Centers for Medicare & Medicaid Services (CMS) has expanded coverage for Personalis's NeXT Personal minimal residual disease test, allowing Medicare beneficiaries with late-stage solid tumors undergoing cancer immunotherapy to receive reimbursement, potentially benefiting hundreds of thousands of Americans.
- Positive Market Reaction: This announcement led to an approximately 11% increase in Personalis (PSNL) shares on Wednesday, reflecting investor confidence in the company's strategy, particularly its significance in cancer treatment management.
- New Treatment Management Tool: The CMS decision provides physicians with an additional tool for proactively managing immunotherapy, helping to identify which patients are responding to treatment, thereby optimizing treatment plans and improving patient outcomes.
- Future Growth Expectations: Personalis anticipates clinical volume targets of 43,000 to 45,000 tests for 2026 while reaffirming its revenue guidance of $78 million to $80 million, indicating sustained growth potential in the cancer testing sector.
See More
Personalis Secures Medicare Coverage for Immunotherapy Monitoring
- Coverage Expansion: The Centers for Medicare & Medicaid Services' (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for Personalis' NeXT Personal minimal residual disease (MRD) test to include immunotherapy monitoring for late-stage solid tumors, marking a significant advancement in cancer treatment management.
- Clinical Evidence Support: Landmark clinical studies conducted in collaboration with the Vall d'Hebron Institute of Oncology (VHIO) demonstrate that NeXT Personal's ultrasensitivity enables real-time evaluation of treatment responses in immunotherapy, optimizing therapeutic pathways and minimizing unnecessary toxicity.
- Patient Benefits: With hundreds of thousands of patients receiving immunotherapy annually in the U.S., the new MRD test will assist physicians in accurately identifying responders and non-responders, thereby enhancing treatment efficacy and reducing costs, ultimately improving patient quality of life.
- Technological Advantage: NeXT Personal employs whole-genome sequencing and advanced noise-suppression technology to achieve sensitivity down to 1 part per million (PPM), providing a high-resolution view of a patient's unique tumor profile, which aids physicians in making more precise treatment decisions in ambiguous imaging scenarios.
See More
