Point of Care Diagnostics Weekly
25.01.25
Inflammatix Gets FDA Clearance for 30-Minute Sepsis Test, Preps for US Launch
Inflammatix, a California-based molecular diagnostics company, has received FDA clearance for its ground-breaking TriVerity Test System, a rapid diagnostic tool for sepsis and acute infections. This innovative test, which provides results in about 30 minutes, marks a significant advancement in the field of sepsis diagnosis and management.
The TriVerity test utilizes a precision medicine approach by measuring the expression of 29 immune-related genes. Using advanced AI algorithms, the test provides three distinct scores indicating the likelihood of bacterial infection, viral infection, and the risk of severe illness requiring critical intervention. This comprehensive approach addresses a fundamental issue in sepsis diagnosis - the need to determine both the presence of infection and the potential for disease progression.
The TriVerity system consists of a single-use test cartridge and the Myrna Instrument, a proprietary benchtop analyzer. The test measures messenger RNA (mRNA) levels to rapidly assess the body's immune response to infection. This approach offers several advantages over traditional diagnostic methods
The FDA clearance was based on results from the SEPSIS-SHIELD study, which demonstrated the test's diagnostic and prognostic accuracy across diverse patient populations.
The introduction of TriVerity could significantly impact sepsis management in emergency departments:
Improved triage: The test may help clinicians quickly identify patients at risk of severe illness, potentially reducing mortality rates.
Antibiotic stewardship: By differentiating between bacterial and viral infections, TriVerity could help reduce unnecessary antibiotic use.
Resource optimization: The test may assist in determining which patients require hospital admission, potentially alleviating strain on healthcare systems9.
The FDA clearance of TriVerity represents a potentially transformative development in sepsis diagnosis and management. By providing rapid, comprehensive information about a patient's infection status and risk of progression, this test could significantly improve clinical decision-making in emergency settings.
The test's ability to differentiate between bacterial and viral infections is particularly noteworthy, as it addresses a critical challenge in antimicrobial stewardship. This feature could play a crucial role in combating the growing threat of antibiotic resistance.
However, as with any new diagnostic tool, the true impact of TriVerity will depend on its successful integration into clinical practice. Factors such as cost-effectiveness, ease of use, and the ability to improve patient outcomes in real-world settings will be critical in determining its long-term success.
As Inflammatix prepares for the US launch of TriVerity, the medical community will be watching closely to see if this innovative approach can deliver on its promise to revolutionize sepsis diagnosis and management. If successful, TriVerity could set a new standard in the field of host response diagnostics and pave the way for more personalized approaches to managing acute infections.
Roche Gets 510(k) Clearance, CLIA Waiver for Liat Triplex Point-of-Care STI Test
Roche, a global healthcare company, has achieved a significant milestone in the field of sexually transmitted infection (STI) diagnostics. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for Roche's cobas liat STI multiplex assay panels. This ground-breaking development promises to revolutionize STI testing and management in various healthcare settings.
The cobas liat STI multiplex assay panels include tests for chlamydia and gonorrhea (CT/NG) as well as a triplex test for chlamydia, gonorrhea, and Mycoplasma genitalium (CT/NG/MG)2. These tests utilize gold-standard PCR technology to deliver results in under 20 minutes, allowing for rapid diagnosis at the point of care.
Clinical Implications
This new testing platform offers several advantages:
Rapid diagnosis: With results available in about 20 minutes, clinicians can diagnose and initiate treatment during a single patient visit.
Multiple pathogen detection: The ability to test for multiple STIs from a single sample streamlines the diagnostic process.
Improved patient care: Quick results can lead to faster treatment initiation, potentially reducing the spread of infections and improving patient outcomes3.
Antibiotic stewardship: Rapid, accurate diagnosis may help reduce unnecessary antibiotic use.
Broader Impact
The introduction of these tests could significantly impact STI management:
Decentralized testing: The CLIA waiver allows for testing in various near-patient settings, including urgent care centers and community health clinics6.
Addressing a global health issue: With over 1 million people acquiring an STI every day worldwide, this technology addresses a critical public health need2.
Tackling asymptomatic infections: The test's sensitivity may help identify asymptomatic cases that might otherwise go undetected5.
Roche plans to make these tests exclusively available in the U.S. market in the coming months, with CE mark commercialization expected to follow shortly2. This staged rollout will allow healthcare providers to integrate this new technology into their practice gradually.
Matt Sause, CEO of Roche Diagnostics, emphasized the transformative potential of this technology:
"Rapid molecular point-of-care testing can revolutionize the clinical management of STIs in decentralized and community-based healthcare settings, enabling informed treatment strategies, better health outcomes for patients, and contain further spread by providing timely diagnosis"
As Roche prepares to launch the cobas liat STI tests in the U.S. market, the medical community eagerly anticipates the impact this technology will have on STI diagnosis and management. The combination of speed, accuracy, and ease of use offered by these tests has the potential to significantly improve patient care and public health outcomes in the fight against sexually transmitted infections.
Osang Healthcare grabs FDA Clearance for COVID-19, Flu Combo Tests
OSANG Healthcare, a South Korean medical diagnostics company, has achieved a significant milestone in the field of infectious disease testing. The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for OSANG's QuickFinder COVID-19/Flu Antigen Self-Test and QuickFinder COVID-19/Flu Antigen Pro Test, marking a crucial advancement in rapid, multi-pathogen diagnostics
Key Features of the QuickFinder Tests
The QuickFinder tests offer several notable advantages:
Rapid results: The tests provide results in approximately 15 minutes
Multi-pathogen detection: They can simultaneously detect SARS-CoV-2, influenza A, and influenza B antigens
Ease of use: The tests utilize simple nasal swab specimens
Versatility: The Self-Test is designed for home use, while the Pro Test is intended for professional use in healthcare settings
The QuickFinder Self-Test is indicated for home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged two years or older
This broad age range makes it a versatile tool for at-home diagnostics, potentially reducing the burden on healthcare facilities during respiratory illness seasons.
CovarsaDx, a prominent Clinical Research Organization, played a crucial role in supporting OSANG Healthcare's FDA clearance. The CovarsaDx research team conducted key studies necessary to validate the tests' safety, effectiveness, and ease of use.
This FDA clearance positions OSANG Healthcare as a key player in the evolving landscape of at-home and professional-use combination tests for respiratory infections. As the medical community continues to grapple with the challenges of differentiating between COVID-19 and influenza, tools like the QuickFinder tests could prove invaluable in guiding treatment decisions and infection control measures. The clearance of OSANG Healthcare's combo tests follows a trend in the industry, with other companies also receiving authorizations for similar products. For instance, in October 2024, the FDA granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, which was the first over-the-counter combination flu and COVID-19 test to be marketed outside of emergency use authorization.
As we move forward, the availability of these combination tests is likely to play a crucial role in managing respiratory illnesses, particularly during peak seasons when multiple pathogens circulate simultaneously. The ability to quickly differentiate between COVID-19 and influenza could significantly impact patient care, public health strategies, and resource allocation in healthcare settings.
Kryptos Biotechnologies Gets $1.2M Grant
Kryptos Biotechnologies, a developer of innovative molecular diagnostic technologies, has secured a $1.2 million grant from the RIGHT Foundation to advance its rapid STI test platform. This significant funding boost marks a crucial step in the company's mission to revolutionize point-of-care diagnostics for infectious diseases.
Grant Details and Project Focus
The $1.2 million grant from the RIGHT Foundation will support Kryptos Biotechnologies in two key areas:
Optimization of their PCR-based test system
Development of a 30-minute test for detecting chlamydia, gonorrhea, and other sexually transmitted infections5
This rapid STI test aims to provide healthcare professionals with quick and accurate results, potentially transforming the landscape of STI diagnosis and treatment.
Technology Overview
Kryptos Biotechnologies' platform is built on groundbreaking technology:
Ultrafast photonic polymerase chain reaction
Fast photothermal heating plasmonic thin film activated by LED
Point-of-care molecular diagnostics1
These innovations enable rapid, cost-effective, and accurate diagnosis of infectious diseases, addressing critical needs in healthcare settings.
Company Background
Founded in 2017, Kryptos Biotechnologies emerged from research conducted at UC Berkeley. The company was co-founded by Dr. Jun Ho Sun, who worked as an Assistant Project Scientist and Postdoctoral Researcher in Professor Luke Lee's lab. This academic pedigree underscores the company's commitment to cutting-edge scientific innovation.
Jinyong Lee, a representative of Kryptos Biotechnologies, emphasized the grant's significance:
"This funding will further our mission to develop advanced point-of-care molecular diagnostics that can fight infections and save lives".
The development of a 30-minute STI test could significantly improve patient care by enabling rapid diagnosis and treatment initiation.
As Kryptos Biotechnologies moves forward with this project, the medical community eagerly anticipates the potential impact of their rapid STI test. If successful, this technology could play a crucial role in addressing the global challenge of sexually transmitted infections, improving public health outcomes, and reducing the spread of these diseases.
43rd Annual J.P. Morgan Healthcare Conference Overview
The 43rd Annual J.P. Morgan Healthcare Conference, held from January 13-16, 2025, in San Francisco, showcased numerous significant announcements and trends in the healthcare industry, particularly in diagnostics and point-of-care testing. Here are some key highlights:
NOWDiagnostics (NOWDx):
Presented their vision for transforming consumer healthcare through in-home testing.
Highlighted their FDA-authorized First To Know Syphilis Test.
Raised $22.5 million in Series B funding.
Announced collaboration with Labcorp for distribution of the First To Know Syphilis Test.
Nvidia:
Partnered with Mayo Clinic to accelerate pathology foundation model development.
Announced collaborations with Iqvia and Illumina.
Mayo Clinic:
Partnered with Nvidia, Microsoft, and Cerebras to test AI tools for imaging assessments and disease identification.
Teladoc:
Announced plans to join Amazon's Health Benefits Connector.
Sutter Health:
Signed a seven-year partnership with GE Healthcare, focusing on AI for accelerating diagnostics.
Johnson & Johnson:
Acquired Intra-Cellular for $14.6 billion, expanding their neuropsychiatric drug portfolio.
GSK:
Acquired IDRx for $1 billion, focusing on rare cancer drugs.
Eli Lilly:
Acquired a clinical oncology drug candidate from Scorpion Therapeutics for up to $2.5 billion in milestone payments.
Key Trends and Insights
AI in Healthcare:
Emphasis on AI's role in drug discovery, personalized medicine, and improving diagnostics.
Focus on leveraging AI for earlier and more accurate disease detection using image analysis, biomarkers, and predictive analytics.
Data Ownership and Sharing:
Increased discussions around data generation and ownership in multi-party collaborations.
Digital Pathology:
Mayo Clinic and Nvidia's partnership aims to accelerate the development of pathology foundation models.
Health Technology:
Companies showcased tools to enhance provider efficiency, advance research, and expand telehealth capabilities.
Personalized Medicine:
Growing importance of AI-driven personalized medicine, tailoring treatments based on individual genetic and clinical data.
Focus on Specific Therapeutic Areas:
Inflammation and immunology (I&I), oncology, and cardio-renal-metabolic diseases were highlighted as areas of strategic interest.
Outpatient Care:
Continued focus on outpatient care as a key growth strategy for healthcare providers.
These developments underscore the healthcare industry's ongoing commitment to innovation, particularly in leveraging AI and data-driven approaches to improve diagnostics, treatment, and overall patient care.
Did I miss any announcements or insider knowledge that I should of known about? Drop me a message and let me know.
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