Latest news with #BreakthroughDevicesProgram
Business Wire
3 days ago
- Business
- Business Wire
FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection (MCD) Test
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA's Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. 'Every late-stage cancer we avert is a win for patients and for the entire healthcare system,' said AmirAli Talasaz, Guardant Health co-founder and co-CEO. 'This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly.' The Breakthrough Device designation by the FDA of the Shield MCD test builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin. At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test showing that the blood-based test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operation' and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release.
Yahoo
3 days ago
- Business
- Yahoo
FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection (MCD) Test
PALO ALTO, Calif., June 03, 2025--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA's Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. "Every late-stage cancer we avert is a win for patients and for the entire healthcare system," said AmirAli Talasaz, Guardant Health co-founder and co-CEO. "This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly." The Breakthrough Device designation by the FDA of the Shield MCD test builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin. At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test showing that the blood-based test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release. View source version on Contacts Investor Contact: Zarak Khurshidinvestors@ Media Contact: Meaghan Smithpress@ Sign in to access your portfolio
Associated Press
3 days ago
- Business
- Associated Press
FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection (MCD) Test
PALO ALTO, Calif.--(BUSINESS WIRE)--Jun 3, 2025-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA's Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. 'Every late-stage cancer we avert is a win for patients and for the entire healthcare system,' said AmirAli Talasaz, Guardant Health co-founder and co-CEO. 'This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly.' The Breakthrough Device designation by the FDA of the Shield MCD test builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin. At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test showing that the blood-based test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit and follow the company on LinkedIn, X (Twitter) and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operation' and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release. View source version on CONTACT: Investor Contact: Zarak Khurshid [email protected] Contact: Meaghan Smith [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: FDA HEALTH ONCOLOGY MEDICAL DEVICES SOURCE: Guardant Health, Inc. Copyright Business Wire 2025. PUB: 06/03/2025 08:05 AM/DISC: 06/03/2025 08:03 AM
The Star
4 days ago
- Business
- The Star
Elon Musk's Neuralink closes Series E funding round
SAN FRANCISCO, June 2 (Xinhua) -- Elon Musk's brain computer interface startup Neuralink announced on Monday that the company has closed a 650-million-U.S.-dollar funding round. The Series E fundraise included investors such as ARK Invest, Founders Fund, Sequoia Capital, and Thrive Capital, among others, the company said in a blog post. Neuralink last raised a 280-million-dollar Series D funding round in 2023, with an additional 43-million-dollar tranche added months later. The company said it has now conducted more human clinical trials, implanting its brain chips in five individuals with severe paralysis. In May, Neuralink received Breakthrough Device Program from the U.S. Food and Drug Administration. The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, according to the Food and Drug Administration. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval.
New Indian Express
05-05-2025
- Health
- New Indian Express
Brain-Computer Interface: How an FDA 'Breakthrough Tag' could expedite voice to the mute
CHENNAI: It's nothing but the dance of mind and machine, where neurons whisper secrets and wires weave dreams. As the digital age revolutionises healthcare, it offers not just healing, but unlocks potentials once trapped in a cage, opening a new way to envision a future where mind and technology live in harmony. The speech restoration device—an AI-driven brain-machine interface designed to assist individuals with severe speech impairments caused by conditions such as stroke, spinal cord injury, amyotrophic lateral sclerosis (ALS), cerebral palsy, and multiple sclerosis—represents a true revolution in healthcare. Although it was a high-risk endeavor for Noland Arbaugh and Brad Smith when Neuralink, the neurotechnology company founded by Elon Musk in 2016, conducted its human trials of this technology in recent years, the prospect of this technology becoming a widely accessible, high-tech therapy for thousands with speech impairments may not be far off. Neuralink recently reached a major milestone in its mission to transform healthcare. Last week, the company announced that its speech restoration device had received the US Food and Drug Administration's (FDA) "Breakthrough Device" designation. This recognition, granted under the FDA's Breakthrough Devices Program, is intended to expedite the development and review of medical technologies that offer significant improvements over existing treatments for life-threatening or irreversibly debilitating conditions. Here's a detailed look at the brain implant's potential to help individuals with severe speech impairments: What Is A Breakthrough Device The FDA's Breakthrough Devices Program is designed to expedite the development, assessment, and review of medical devices that can provide significant improvements over current treatment options. The goal is to offer patients and healthcare providers faster access to innovations that could meaningfully improve health outcomes. By granting this designation to Neuralink's speech restoration device, the FDA aims to accelerate the device's journey toward becoming a clinically available treatment for individuals with severe neurological conditions. This speech restoration device has been specifically designed to assist individuals suffering from severe speech impairments caused by neurological conditions. These conditions include amyotrophic lateral sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, multiple sclerosis, and other disorders that impact the brain's ability to control speech. For individuals with these conditions, communication can become incredibly difficult, severely limiting their quality of life. The speech restoration device seeks to restore communication abilities by utilizing a brain-computer interface (BCI) that allows users to communicate through neural signals. The Revolution that Neuralink Technology offers: Currently there are three key BCI driven healthcare solutions that Neuralink has designed and developed. N1 Implant: At the heart of Neuralink's mission is its N1 implant, a small, coin-sized device designed to be implanted in the brain. Equipped with flexible threads containing electrodes, the N1 implant can detect neural activity and transmit these signals to external devices. This allows for direct communication between the brain and the device, bypassing damaged pathways in the brain and nervous system. The device is implanted using a robotic surgical system designed to minimize invasiveness and maximize precision. This technology is central not only to speech restoration but also to other treatments that Neuralink is exploring for neurological conditions. Blindsight: Another groundbreaking product from Neuralink is Blindsight, an experimental device aimed at restoring vision in individuals with total visual impairment. Instead of relying on the optic nerve, Blindsight directly stimulates the visual cortex of the brain, bypassing damaged pathways and enabling the brain to create a visual perception. The FDA has also granted Breakthrough Device Designation to Blindsight, highlighting its potential to change the lives of individuals who have lost their sight due to optic nerve damage. Speech Restoration Device: The speech restoration device, which earned FDA's Breakthrough Device Designation, is the latest in Neuralink's portfolio. This device aims to assist individuals with speech impairments due to various neurological disorders. The device's development underscores the company's commitment to improving the lives of individuals affected by debilitating conditions. Clinical Applications and Trials: A New Era in Neurological Care Neuralink has been actively testing its devices in human clinical trials. In January 2024, Noland Arbaugh became the first human recipient of a Neuralink implant. While the device faced some challenges, including the retraction of implant threads, it enabled Arbaugh to control a computer cursor with his thoughts, demonstrating the potential for BCIs to restore digital autonomy to individuals with paralysis. In April 2025, Brad Smith, a man paralysed by ALS, became the third recipient of a Neuralink implant. Smith's ability to use the device to type, edit videos, and communicate through brain-controlled cursor movements marked a significant leap forward in restoring the ability to communicate for individuals with severe neurological impairments. This success story illustrates how BCIs can dramatically improve the quality of life for people with disabilities, giving them a voice when traditional methods of communication are no longer viable. Ethical Considerations and Challenges As promising as Neuralink's technology is, it raises a host of ethical and technical questions. Some of the most pressing concerns include:
