The American Medical Association Approves a New Category I CPT® Code for the HelioLiver™ Test
The approval of a CPT code establishes a reimbursement pathway for increased access to HelioLiver, a simple blood test to detect hepatocellular carcinoma (HCC) – the primary form of liver cancer
HelioLiver is currently available through a provider order – visit www.helioliver.com to learn more
HelioLiver, launched in
"Receiving a CPT PLA code for HelioLiver marks an important step towards our vision to enable widespread, affordable access of life-saving tools for at-risk populations who need clear and convenient answers about their health," said
The CPT PLA code for HelioLiver will allow providers to efficiently conduct routine surveillance of at-risk patients and streamline the reporting of services, claims processing and development of guidelines for medical care review, ultimately advancing more sophisticated and comprehensive care for patients.
About Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the most common form of liver cancer. According to the
Other conditions that are associated with HCC development are: hepatitis C, excessive alcohol use, nonalcoholic fatty liver disease (NAFLD), and inherited diseases such as hereditary hemochromatosis, primary biliary cholangitis (PBC), and Wilson's disease.
HelioLiver is a multi-analyte blood test that incorporates cell-free DNA (cfDNA) methylation patterns, serum protein markers, and demographic information for the detection of hepatocellular carcinoma.
Based on results from the ENCORE Phase 2 prospective, blinded, multi-center study, HelioLiver demonstrated high specificity (91%) and high sensitivity (76%) in detecting early-stage (I and II) HCC, significantly outperforming other clinically available detection tools such as AFP (57%) and GALAD (65%). Ultrasound, as standard of care, showed only 47% sensitivity for early-stage HCC.1 When considering HCC at all stages, HelioLiver performed at an 85% sensitivity with the same 91% specificity.1 By detecting HCC in earlier stages, HelioLiver allows patients access to more curative options and improve outcomes overall.
About Helio Genomics
Helio Genomics is an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw. The company's mission is to simplify cancer screening so lives can be saved by detecting cancer earlier. With Helio's AI-driven technology, both physicians and their patients gain powerful insights from accurate, accessible, and convenient blood tests. Helio's development program is focused on liver, colon, breast and lung cancer.
Helio Genomics is headquartered in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about, among other things: guidance regarding expected annual financial results, including revenues, core revenues, GAAP income, and non-GAAP income; evaluations and judgments regarding market position, balance sheet, runway, momentum, reinvestments, shareholder value, acquisition strategies, and synergies related to and the performance of acquired businesses (including
Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the Company's future performance, and they are based on management's current assumptions, expectations, and beliefs concerning future developments and their potential effect on the Company's business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others: the ongoing impacts of the COVID-19 pandemic, including the preventive public health measures that may continue to impact demand for its tests and the pandemic's effects on the global supply chain; the market potential for, and the rate and degree of market adoption of, the Company's tests, including its tests for COVID-19 and genetic testing generally; the Company's ability to capture a sizable share of the developing market for genetic and COVID-19 testing and to compete successfully in these markets, including its ability to continue to develop new tests that are attractive to its various customer markets, its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the Company's ability to maintain the low internal costs of its business model, particularly as the Company makes investments across its business; the Company's ability to maintain an acceptable margin on sales of its tests, particularly in light of increasing competitive pressures and other factors that may continue to reduce the Company's sale prices for and margins on its tests; risks related to volatility in the Company's results, which can fluctuate significantly from period to period; risks associated with the composition of the Company's customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the Company's revenue; the Company's ability to grow and diversify its customer base and increase demand from existing and new customers; the Company's investments in its infrastructure, including its sales organization and operational capabilities, and the extent to which these investments impact the Company's business and performance and enable it to manage any growth it may experience in future periods; the Company's level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests; the Company's level of success in establishing and obtaining the intended benefits from partnerships, strategic investments, joint ventures, acquisitions, or other relationships; the Company's compliance with the various evolving and complex laws and regulations applicable to its business and its industry; risks associated with the Company's international operations; the Company's ability to protect its proprietary technology platform; and general industry, economic, political and market conditions. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.
The forward-looking statements made in this press release speak only as of the date of this press release, and the Company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required by law.
The Company's reports filed with the
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1 Lin N, Lin Y, Xu J, et al. A multi-analyte cell-free DNA–based blood test for early detection of hepatocellular carcinoma. Hepatol Commun. 2022;00:1–11. doi:10.1002/hep4.1918.
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