NeoGenomics’ PanTracer LBx Receives Medicare Coverage, Expanding Access to Comprehensive Liquid Biopsy Profiling

Key Terms

liquid biopsy medical

A liquid biopsy is a laboratory test that looks for tiny pieces of tumor or disease-related material — such as DNA, proteins, or cells — circulating in blood or other body fluids, allowing detection and monitoring without a surgical tissue sample. For investors, it matters because these tests can speed diagnosis, guide treatment choices, enable easier repeat testing, and create recurring revenue streams if adopted widely, affecting a medical company's growth and regulatory risk profile.

comprehensive genomic profiling medical

Comprehensive genomic profiling is a laboratory test that reads a large portion of a tumor’s or patient’s DNA to find many possible genetic changes at once, like using a detailed map instead of a single street view. For investors, it matters because results can guide targeted treatments, influence demand for companion diagnostics and drugs, and affect regulatory approvals and reimbursement, all of which can drive clinical adoption and commercial value.

clia-certified regulatory

CLIA-certified means a laboratory has passed U.S. federal standards for performing tests on human samples, showing its results are accurate, reliable and timely. For investors this matters because certification is often required to sell clinical test services, bill insurers, win hospital or physician partnerships and avoid regulatory penalties — much like a restaurant passing a health inspection or a car getting a safety sticker before it can be sold.

centers for medicare & medicaid services regulatory

The Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that runs major public health insurance programs and sets rules for what treatments and services are paid for and how much providers receive. Think of it as the rulebook and paymaster for a large portion of the health-care system: its coverage decisions, payment rates, and regulations can quickly change revenues, costs, and market access for hospitals, insurers, drugmakers and medical-device companies, so investors track its actions closely.

FORT MYERS, Fla.--(BUSINESS WIRE)-- NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of oncology diagnostic solutions that enable precision medicine, today announced the PanTracer™ LBx test has received coverage from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) under LCD - MolDX: Plasma-Based Genomic Profiling in Solid Tumors (L38043). This decision will enable Medicare patients to receive coverage for PanTracer LBx, a blood-based comprehensive genomic profiling (CGP) test designed to support therapy selection and clinical trial enrollment in patients with advanced solid tumors. The LBx test is performed in our CLIA-certified laboratory in California.

“Securing Medicare coverage for PanTracer LBx represents a significant milestone in making precision oncology more accessible, particularly for those choosing treatment in the community setting,” said Tony Zook, Chief Executive Officer of NeoGenomics. “This coverage decision reinforces the clinical value of liquid biopsy and enables physicians to deliver timely, personalized treatment strategies for their patients.”

With a seven-day turnaround, PanTracer LBx provides actionable biomarker information from a simple blood draw, evaluating more than 500 genes, including MSI and bTMB. It can be ordered as a standalone test, as a reflex when tissue testing is insufficient, or concurrently with tissue analysis, providing flexibility to meet the needs of both patients and clinicians.

As part of NeoGenomics’ PanTracer portfolio, PanTracer LBx complements PanTracer Tissue to enable comprehensive pan-solid tumor profiling across care settings. Medicare patients can now access this noninvasive genomic test, expanding availability and reducing barriers to advanced cancer diagnostics. This decision supports broader clinical adoption, reinforces the company’s position in precision oncology, and underscores the real-world utility of liquid biopsy in guiding patient care.

About NeoGenomics

NeoGenomics, Inc. is a premier cancer diagnostics company specializing in cancer genetics testing and information services. We offer one of the most comprehensive oncology-focused testing menus across the cancer continuum, serving oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic and predictive testing to help them diagnose and treat cancer. Headquartered in Fort Myers, FL, NeoGenomics operates a network of CAP-accredited and CLIA-certified laboratories for full-service sample processing and analysis services throughout the US and a CAP-accredited full-service sample-processing laboratory in Cambridge, United Kingdom.

Forward Looking Statements

This press release includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “can,” “could,” “would,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” “guidance,” “potential” and other words of similar meaning, although not all forward-looking statements include these words. These forward-looking statements include statements regarding the potential of PanTracer LBx to support therapy selection, clinical trial enrollment and longitudinal disease monitoring in patients with advanced solid tumors; the Company’s expectations regarding the correlation between the availability of Medicare coverage and the ability of physicians to deliver timely, personalized treatment strategies for their patients; and the potential impact of Medicare coverage to support wider clinical adoption of PanTracer LBx, reinforce the Company’s position in precision oncology, and underscore the real-world utility of liquid biopsy in guiding patient care. Each forward-looking statement contained in this press release is subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Applicable risks and uncertainties include, among others, risks with respect to the Company’s ability to maintain Medicare coverage for its products and the market acceptance of its products, as well as the risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and the Company's other filings with the Securities and Exchange Commission.

We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and in the “Investors” section of our website at ir.neogenomics.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document (unless another date is indicated), and we undertake no obligation to update or revise any of these statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

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Investor Contact

Kendra Webster

InvestorRelations@neogenomics.com

Media Contact

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Source: NeoGenomics, Inc.