PALO ALTO, Calif. - Guardant Health , Inc. (NASDAQ: NASDAQ:GH), a precision oncology company, has received certification under the European Union's In Vitro Diagnostic Regulation (IVDR 2017/746) for its Guardant360® CDx blood test.
This certification, granted by TÜV SÜD Product Service, allows the test to be used for tumor mutation profiling across all solid cancerous tumors and for identifying patients who may benefit from targeted therapies for advanced non-small cell lung cancer and breast cancer.
The IVDR certification represents a significant advancement in cancer care within the EU, as it will likely facilitate the broader use of genomic profiling in clinical practice. The Guardant360 CDx test, which is a next-generation sequencing-based assay, utilizes circulating tumor DNA from blood samples to detect genomic alterations.
This liquid biopsy offers a less invasive alternative to traditional tissue biopsies, enabling faster and potentially more accessible comprehensive genomic profiling for patients with advanced cancer.
Helmy Eltoukhy, Guardant Health chairman and co-CEO, expressed confidence that this certification would expedite the adoption of genomic profiling and support the development of new targeted therapies, ultimately increasing the number of patients receiving personalized treatments.
The IVDR certification means that Guardant360 CDx can now be used in the EU as a companion diagnostic tool. It can identify patients with non-small cell lung cancer who may benefit from specific treatments, such as TAGRISSO® (osimertinib), RYBREVANT® (amivantamab), or LUMYKRAS® (sotorasib), and those with advanced breast cancer with ESR1 mutations for treatment with ORSERDU™ (elacestrant).
Guardant360 CDx's importance is underscored by the potential impact on clinical trials and treatment matching, as well as by the more than 400 peer-reviewed publications and its use by over 12,000 oncologists to date.
The test first received U.S. FDA approval in August 2020 and a CE mark for tumor mutation profiling in March 2021. It provides genomic results from a blood draw in seven days, covering all genes recommended by the National Comprehensive Cancer Network, including those relevant to non-small cell lung cancer treatment guidelines.
This certification is based on a press release statement.
InvestingPro Insights
Guardant Health, Inc. (NASDAQ: GH) has recently achieved a significant regulatory milestone with the IVDR certification of its Guardant360® CDx blood test in the EU. The financial metrics and analyst perspectives provided by InvestingPro offer additional context for investors considering the company's stock. Guardant Health's market capitalization stands at approximately $3.03 billion, reflecting the market's valuation of the company's potential in the precision oncology space.
The company's revenue growth has been notable, with a 25.21% increase in the last twelve months as of Q1 2024, and a quarterly revenue growth of 30.9% in Q1 2024. This indicates a strong demand for its diagnostic products and services. However, despite these revenue increases, Guardant Health is not currently profitable, with a negative P/E ratio of -6.27 and an adjusted P/E ratio for the last twelve months of -7.46. This aligns with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year.
InvestingPro Tips highlight that while the company is not profitable over the last twelve months, it has seen a strong return over the last month, with a 54.14% increase in its stock price. This could be a sign of growing investor confidence following the IVDR certification and the potential expansion in the EU market. Additionally, the company's liquid assets exceed its short-term obligations, which may provide some financial stability in the near term.
For investors looking for deeper insights and additional analyst perspectives, there are 7 more InvestingPro Tips available for Guardant Health at https://www.investing.com/pro/GH. These can be accessed with a special offer using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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