Abionic, a Swiss diagnostics company, has recently received FDA 510(k) clearance for its IVD CAPSULE PSP test, marking a significant milestone in the early detection of sepsis. This clearance paves the way for the commercialization of their sepsis test in the U.S., a crucial step in addressing a major public health challenge.
Sepsis is a life-threatening condition caused by the body’s extreme response to an infection. It affects approximately 50 million people globally each year, resulting in 11 million deaths1. In the U.S. alone, sepsis impacts 1.7 million patients annually and incurs healthcare costs of around $38 billion. Early detection is vital, as timely intervention can significantly improve patient outcomes.
The IVD CAPSULE PSP test utilizes the Pancreatic Stone Protein (PSP) biomarker, which is produced by the pancreas and immune cells in response to infections and inflammation. Elevated PSP levels can indicate the onset of sepsis 24 to 48 hours earlier than current diagnostic methods. This early detection capability is crucial for initiating prompt treatment and improving survival rates.
The test operates on the abioSCOPE platform, a rapid diagnostics system that delivers lab-quality results from a single drop of blood within minutes1. This integration into routine clinical workflows ensures that healthcare providers can quickly and accurately assess a patient’s risk of sepsis, enabling timely and informed treatment decisions.
The FDA clearance of Abionic’s IVD CAPSULE PSP test represents a significant advancement in the fight against sepsis. The ability to detect sepsis earlier than traditional methods can transform patient care in critical settings. By providing rapid, reliable results, this test can help reduce the high mortality rates associated with sepsis and alleviate the substantial economic burden on healthcare systems.
Moreover, the deployment of this test across the U.S. could set a new standard for sepsis diagnostics, encouraging further innovation in the field. The integration of nanofluidics technology in the abioSCOPE platform exemplifies how cutting-edge science can be harnessed to address pressing medical challenges.
In conclusion, Abionic’s FDA clearance is a promising development that underscores the importance of early detection in managing sepsis. As this technology becomes more widely available, it has the potential to save countless lives and improve the quality of care for patients at risk of sepsis.
What are your thoughts on this breakthrough? Do you think it will significantly impact sepsis management in the U.S.?
Atomo Diagnostics, an Australian medical device company, has been awarded a a $2.4 million grant by the Australian Department of Industry, Science, and Resources to develop a ground-breaking syphilis test. This funding will support the creation of a point-of-care and home-use test, addressing a critical need in public health.
Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. Despite being treatable, syphilis remains a significant public health issue, with rising infection rates globally. In Australia, the number of infectious syphilis cases has more than tripled over the past decade.
The new test being developed by Atomo Diagnostics aims to distinguish between active and previously treated syphilis infections. This is particularly important as it helps in accurately diagnosing and managing the disease. The test will utilize Atomo’s Pascal cartridge-based testing platform, which allows for rapid and reliable results from a simple finger-prick blood sample.
This project is a collaboration with the Burnet Institute, a leading medical research organization, and the IDE Group, which specializes in medical technology development and commercialization. The goal is to create a test that can be used both in clinical settings and at home, providing greater accessibility and convenience for patients.
The a $2.4 million grant awarded to Atomo Diagnostics is a significant step forward in the fight against syphilis. The development of a rapid, point-of-care test that can distinguish between active and past infections is a game-changer. It not only enhances diagnostic accuracy but also facilitates timely treatment, which is crucial in preventing the spread of the infection.
Moreover, the ability to use this test at home empowers individuals to take control of their health, reducing the stigma associated with sexually transmitted infections and encouraging more people to get tested. This innovation could lead to earlier detection and treatment, ultimately reducing the prevalence of syphilis.
Atomo Diagnostics’ success with their HIV Self-Test demonstrates their capability in developing effective diagnostic tools. Leveraging their existing commercial channels for the new syphilis test could accelerate its adoption and impact.
In conclusion, this grant and the subsequent development of the syphilis test highlight the importance of innovation in addressing public health challenges. By making testing more accessible and accurate, Atomo Diagnostics is poised to make a significant impact on the management and prevention of syphilis.
What do you think about this development? Do you believe it will make a substantial difference in syphilis management?
OralDNA Labs, a leader in salivary diagnostics, has acquired Sensible Diagnostics’ point-of-care qPCR technology, marking a significant advancement in rapid molecular diagnostics. This acquisition aims to enhance the speed and accuracy of diagnostic testing, providing clinicians with real-time, actionable results.
Quantitative Polymerase Chain Reaction (qPCR) is a powerful molecular technique used to amplify and quantify DNA sequences. It is widely used in diagnostics due to its high sensitivity and specificity. The point-of-care qPCR technology developed by Sensible Diagnostics allows for rapid detection of pathogens directly at the site of patient care, significantly reducing the time to diagnosis.
OralDNA Labs plans to integrate this technology into their existing diagnostic platforms, focusing initially on the oral microbiome. This integration will enable the detection of periodontal pathogens and other oral health-related conditions within minutes, using saliva or swab samples1. The technology’s microfluidic test cartridges and fast, 4-channel system are designed to deliver central lab-quality results quickly and efficiently.
The acquisition of Sensible Diagnostics’ qPCR technology by OralDNA Labs is a promising development in the field of molecular diagnostics. The ability to perform rapid, accurate tests at the point of care can revolutionize patient management, particularly in dental and oral health settings. By providing immediate results, clinicians can make informed decisions on treatment plans without the delays associated with traditional lab testing.
This technology also has the potential to expand beyond oral health, offering rapid diagnostics for a variety of infectious diseases. The convenience and speed of point-of-care testing can improve patient outcomes by enabling timely interventions and reducing the spread of infections.
In conclusion, OralDNA Labs’ acquisition of Sensible Diagnostics’ qPCR technology represents a significant step forward in enhancing diagnostic capabilities. This innovation underscores the importance of rapid, accurate testing in improving healthcare delivery and patient care.
What are your thoughts on this acquisition? Do you think it will significantly impact the field of molecular diagnostics?
The Advanced Research Projects Agency for Health (ARPA-H) has awarded $110 million to 23 commercial and academic teams as part of its Sprint for Women’s Health program. This initiative aims to address critical challenges in women’s health through innovative research and development.
Women’s health has historically been underfunded and under-researched, leading to gaps in treatment and care. The Sprint for Women’s Health program seeks to bridge these gaps by funding projects that tackle a wide range of conditions, including cancer, ovarian health, gynaecological care, endometriosis, obstetrics, menopause, lymphatics, pain management, neurological conditions, and cardiovascular conditions.
Among the awardees, several notable projects stand out:
- Aspira Women’s Health received $10 million to develop the EndoMDx test, a multi-marker blood test designed to aid in the detection of endometriosis.
- Washington University in St. Louis was awarded $3.4 million to create a blood test and mobile app for assessing endometriosis pain levels and guiding treatment decisions.
- Gravidas Diagnostics in Los Angeles received $3 million to develop a home test for the early detection of preeclampsia in pregnant women.
- Glaucus in Brooklyn was granted $3 million to develop the NanoBioChip, a microchip-based testing system capable of at-home testing for up to 50 sexually transmitted infections.
These projects were selected for their high-impact and novel approaches, with the potential to significantly improve women’s health outcomes.
The ARPA-H’s substantial investment in women’s health research is a much-needed and commendable initiative. By funding a diverse array of projects, this program addresses the multifaceted nature of women’s health issues, which have often been overlooked in traditional research funding.
The focus on point-of-care and at-home testing is particularly promising. These innovations can lead to earlier detection and treatment, reducing the burden on healthcare systems and improving patient outcomes. For instance, the development of the EndoMDx test by Aspira Women’s Health could revolutionize the diagnosis and management of endometriosis, a condition that affects millions of women worldwide but is often misdiagnosed or diagnosed late.
Moreover, the emphasis on integrating digital health solutions, such as mobile apps for pain assessment and management, aligns with the growing trend towards personalized and accessible healthcare. These tools empower patients to take control of their health, leading to better adherence to treatment plans and improved quality of life.
In conclusion, the ARPA-H’s Sprint for Women’s Health program is a significant step forward in addressing the long-standing disparities in women’s health research and care. By supporting innovative and high-impact projects, this initiative has the potential to transform the landscape of women’s health, leading to better outcomes and a brighter future for women globally.
What are your thoughts on this initiative? Do you think it will lead to substantial improvements in women’s health?
We are thrilled to announce a fantastic new feature in our Point of Care Weekly Newsletter! Starting this Monday, you’ll receive an extra edition every Monday morning, packed with exclusive insights and updates.
Missed last week’s edition? No worries! Our form updates weekly, so you can always catch up on previous companies and discover the latest additions.
Here’s what you can look forward to:
- Names of Companies & Leadership Teams
- Lead Partners
- Details of Funding Rounds
- Company Missions & Overviews
This is a valuable resource you won’t want to miss! Be sure to share this exciting news with anyone who might be interested. Stay tuned and get ready for your Monday mornings to be more informative and inspiring than ever! 🚀
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