Personalis Announces Medicare Coverage for NeXT Dx(R) Comprehensive Genomic Tumor Profiling Assay

Rhea-AI Summary

Personalis, Inc. (Nasdaq: PSNL) has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries. NeXT Dx analyzes a tumor’s entire exome and transcriptome to uncover deeper insights into therapy selection, including RNA-based fusions, tumor mutational burden, and microsatellite instability. The coverage for NeXT DX was extended effective August 29, 2023, under the Palmetto GBA MolDx program foundational Local Coverage Determination. Approximately half of new solid tumor cancer cases will be diagnosed in patients covered by Medicare. Personalis also recently launched the ultra-sensitive NeXT Personal Dx test for detecting molecular residual disease and cancer recurrence.

Positive

• Personalis, Inc. has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries.
• NeXT Dx analyzes a tumor’s entire exome and transcriptome to uncover deeper insights into therapy selection, including RNA-based fusions, tumor mutational burden, and microsatellite instability.
• The coverage for NeXT DX was extended effective August 29, 2023, under the Palmetto GBA MolDx program foundational Local Coverage Determination.
• Approximately half of new solid tumor cancer cases will be diagnosed in patients covered by Medicare.
• Personalis also recently launched the ultra-sensitive NeXT Personal Dx test for detecting molecular residual disease and cancer recurrence.

Negative

• None.

Oncology Doctor

The final Medicare coverage determination for Personalis Inc.'s NeXT Dx assay represents a significant advancement in precision oncology. The ability of NeXT Dx to analyze both the exome and transcriptome of a tumor provides a more comprehensive understanding of the cancer's genomic makeup. This is crucial for identifying a broader range of clinically actionable genomic alterations, such as RNA-based fusions, tumor mutational burden (TMB) and microsatellite instability (MSI), which are key factors in personalizing cancer treatment.

From a clinical perspective, the use of paired tumor and non-tumor samples enhances the accuracy of the genomic profiling, which is essential for identifying the most effective treatment options, including FDA-approved therapies and clinical trial opportunities. The impact of this coverage on patient care is considerable, as it enables access to advanced diagnostic tools that can guide treatment decisions for a significant portion of the population affected by solid tumor cancers, particularly those covered by Medicare.

Healthcare Economist

The extension of Medicare coverage for the NeXT Dx test has substantial implications for the economics of healthcare, particularly within the oncology sector. By providing coverage for an ultra-comprehensive genomic profiling assay, Medicare is recognizing the value of precision medicine and its potential to improve outcomes while potentially reducing the overall cost of cancer care. Precision diagnostics can lead to more targeted and effective treatments, which may translate to cost savings by avoiding less effective, one-size-fits-all therapies.

Moreover, the decision to cover this test under the Palmetto GBA MolDx program could incentivize further innovation in the field, as it demonstrates a willingness to support advanced diagnostic methods. This coverage could also have a ripple effect on private insurers, who may follow Medicare's lead in providing coverage for similar genomic profiling assays, thereby expanding access even further.

Market Research Analyst

The announcement by Personalis Inc. regarding Medicare coverage for its NeXT Dx test is likely to have a positive impact on the company's market position. With an estimated 50% of new solid tumor cases diagnosed in Medicare beneficiaries, the potential market for NeXT Dx is substantial. This coverage determination could lead to increased adoption of the test, which in turn may drive revenue growth for Personalis.

Investors should note the strategic significance of this coverage in the context of Personalis's product pipeline, including the early access launch of the NeXT Personal Dx test for detecting molecular residual disease. The company's focus on comprehensive genomic profiling throughout a cancer patient's journey positions it to capitalize on the growing trend towards personalized medicine in oncology, which is increasingly being supported by insurers and healthcare systems.

NeXT Dx helps clinicians make informed, personalized cancer treatment selections and match patients with clinical trials

Access to NeXT Dx expands to the 66 million Medicare and Medicare Advantage beneficiaries

FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced it has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries.

Matching patients to their optimal cancer therapy requires a testing platform that can accurately report a broader range of clinically actionable genomic alterations. NeXT Dx analyzes a tumor’s entire exome (DNA) and transcriptome (RNA) to uncover deeper insights into therapy selection, including RNA-based fusions and advanced biomarkers that smaller panels might miss, such as tumor mutational burden (TMB) and microsatellite instability (MSI). In addition, NeXT Dx utilizes paired tumor and non-tumor samples to report more accurate results.

Coverage for NeXT DX was extended effective August 29, 2023, under the Palmetto GBA MolDx program foundational Local Coverage Determination (LCD) L38119 (“Next-Generation Sequencing for Solid Tumors”). Personalis estimates that approximately half of new solid tumor cancer cases will be diagnosed in patients covered by Medicare.

“We are thrilled to receive our first coverage determination with our ultra-comprehensive NeXT Dx test, which offers treating physicians a better chance of finding an FDA-approved therapy or clinical trial for patients with advanced cancer,” said Chris Hall, President and Chief Executive Officer at Personalis. “With our recent early access launch of the ultra-sensitive NeXT Personal Dx test, which is designed to detect molecular residual disease and cancer recurrence, we continue our momentum in offering products that provide deep genomic insights throughout a cancer patient’s entire journey.”

About Personalis

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect MRD and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).

Forward-Looking Statements

All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to attributes or advantages of the NeXT Dx or NeXT Personal assays, the expected benefits of the Medicare coverage determination for NeXT Dx, the expected launch of NeXT Personal Dx into the clinical market, or other future events. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements. Factors that could materially affect actual results can be found in Personalis’ filings with the U.S. Securities and Exchange Commission, including Personalis’ most recent reports on Forms 8-K, 10-K and 10-Q, and include those listed under the caption “Risk Factors.” Personalis disclaims any obligation to update such forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240116509384/en/

Investors:

Caroline Corner

investors@personalis.com

415-202-5678

Media:

Consort Partners

pr@personalis.com

Source: Personalis, Inc.

What is the ticker symbol for Personalis, Inc.?

The ticker symbol for Personalis, Inc. is PSNL.

What is the Medicare coverage determination for NeXT Dx?

The NeXT Dx ultra-comprehensive tumor genomic profiling assay has received a final Medicare coverage determination, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries.

What does NeXT Dx analyze?

NeXT Dx analyzes a tumor’s entire exome and transcriptome to uncover deeper insights into therapy selection, including RNA-based fusions, tumor mutational burden, and microsatellite instability.

When was the coverage for NeXT DX extended?

The coverage for NeXT DX was extended effective August 29, 2023, under the Palmetto GBA MolDx program foundational Local Coverage Determination.

What is the NeXT Personal Dx test for?

The NeXT Personal Dx test is designed for detecting molecular residual disease and cancer recurrence.