FT. MYERS, Fla. - NeoGenomics, Inc. (NASDAQ: NASDAQ:NEO), a provider of oncology testing services, has received conditional approval from the New York State Department of Health (NYSDOH) for two of its next-generation sequencing (NGS) tests. The approved assays, Neo Comprehensive Solid Tumor and NeoTYPE DNA & RNA Lung, are now available for commercial use in New York State. This development is expected to enhance the precision of cancer diagnostics and treatment options available to patients across the state.
The approval by NYSDOH, which is recognized for its rigorous standards, underscores the quality and reliability of NeoGenomics' tests. These tests offer a pan-tumor genomic profiling solution, aligning with National Comprehensive Cancer Network (NCCN) guidelines and addressing an unmet need in lung cancer testing. They are designed to detect a broad panel of genetic markers, including less common ones that may be missed by cancer-specific profiles or single-gene tests.
Warren Stone, CCO of NeoGenomics, emphasized the significance of this milestone, stating that it confirms the company's commitment to high standards in test development and lab results quality. The approval allows NeoGenomics to expand the reach of these diagnostic tools to more healthcare providers and patients in New York, aiding in the management of diverse cancers.
In New York State, cancer is a leading health concern, with lung cancer being the most common cause of cancer-related death. The availability of these NGS tests is particularly important as they provide a comprehensive genomic profiling solution that can guide the first-line treatment of various solid tumors, including non-small cell lung cancer.
NeoGenomics operates laboratories across the United States that are certified by the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP), ensuring high standards of quality, safety, and accuracy in their testing services.
The company cautions that the press release contains forward-looking statements, which involve certain risks and uncertainties that could cause actual results to differ materially from those projected. These statements are based on current expectations and assumptions and are subject to factors such as the company's ability to improve performance, recruit executive candidates, gain new customers, and implement its business plan.
This news is based on a press release statement from NeoGenomics, Inc. and does not include any marketing promotion or endorsement of the company or its products.
In other recent news, Neogenomics has been making significant strides, both in its financial performance and in its research and development efforts. The company reported a robust 12% growth in revenue for the second quarter of 2024, totaling $165 million, largely driven by its Next-Generation Sequencing (NGS) business. This positive financial trajectory led to Needham and Benchmark both maintaining their Buy ratings for the company.
Neogenomics also successfully completed the feasibility stage for its new version of the RaDaR molecular residual disease (MRD) test. This development comes after settling a patent litigation issue with Natera (NASDAQ:NTRA), lifting uncertainties that had been weighing on the company. Management confirmed that this settlement would not significantly impact the company's financial performance.
Analysts from Needham and Benchmark highlighted the company's consistent rise in revenue per test, marking the thirteenth consecutive quarter of improvement. This growth was largely driven by the company's pricing strategies and the volume of NGS tests. Furthermore, significant improvements were noted in the company's profitability, with both the adjusted gross margin and EBITDA margin seeing substantial year-over-year increases.
With these recent developments, Neogenomics continues to maintain a positive financial trajectory and innovative momentum in the field of molecular diagnostic testing.
InvestingPro Insights
NeoGenomics' recent approval from the New York State Department of Health for its next-generation sequencing tests aligns with the company's growth trajectory. According to InvestingPro data, NeoGenomics has shown a revenue growth of 13.89% over the last twelve months, with revenues reaching $628.25 million. This expansion in their test offerings could potentially contribute to further revenue growth.
Despite the positive news, it's worth noting that NeoGenomics is currently operating at a loss, with an operating income of -$87.11 million over the last twelve months. However, an InvestingPro Tip suggests that analysts predict the company will be profitable this year, which could be influenced by the expanded market access for their newly approved tests.
The company's stock performance has been challenging recently, with a 19.35% decline in the past month. This aligns with another InvestingPro Tip indicating that the stock has fared poorly over the last month and is trading near its 52-week low. Investors might view the recent regulatory approval as a potential catalyst for future stock performance improvement.
For those interested in a deeper analysis, InvestingPro offers 7 additional tips for NeoGenomics, providing a more comprehensive view of the company's financial health and market position.
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