for Point of Care (POC) diagnostics & evaluation, focusing on business, financial, and growth levers, for the selection and partnering of med-tech start-ups

• Types of Tests

  • Diagnostic tests
    • Molecular tests (PCR and other NAATs tests)
    • Antigen tests (rapid tests or self-tests)
    • Samples for diagnostic tests are typically collected using an anterior nares (nasal) swab sample. Some diagnostic tests use other samples such as mid-turbinate, nasopharyngeal, oropharyngeal, or saliva samples.
  • Antibody tests
    • Look for antibodies in your blood that your immune system produced in response to SARS-CoV-2.
    • Should not be used to diagnose a current SARS-CoV-2 infection or COVID-19 and, at this time, should also not be used to check for immunity.
    • Samples for antibody tests are typically collected by a doctor or other medical professional by taking blood from a finger stick or your vein.

• Types of Samples

  • Swab samples use a swab (similar to a long Q-Tip) to collect a sample from the nose or throat. The types of samples include:
    • Anterior Nares (Nasal) – takes a sample from just inside the nostrils
    • Mid-turbinate – takes a sample from further up inside the nose
    • Nasopharyngeal – takes a sample from deep inside the nose, reaching the back of the throat, and should only be collected by a trained health care provider
    • Oropharyngeal – takes a sample from the middle part of the throat (pharynx) just beyond the mouth, and should only be collected by a trained health care provider
  • Saliva samples are collected by spitting into a tube rather than using a nose or throat swab.
  • Blood samples are only used to test for antibodies and not to diagnose COVID-19. Venous blood samples are typically collected at a doctor’s office or clinic. Some antibody tests use blood samples from a finger stick.

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• COVID-19 pandemic led to new trends in medical technology, with a focus on digital devices and remote monitoring
  • Increased use of telehealth services and digital technologies
  • Telehealth services were deemed transformative in reducing disease exposure for patients and healthcare workers
  • Remote patient monitoring surged after FDA issued new guidance in March 2020
• Point-of-care testing and diagnostics will continue to be a focus for medical devices
  • POC testing benefits from leveraging AI and machine learning for infectious disease testing
  • Home use devices and testing tools will be critical for provision of care
• Smart, connected devices are on the rise, and will play a crucial role in the future of medical technology
  • Greater interest in collecting and providing real-time data from patients to care providers
  • IoT and connected devices will be critical in expanding diagnostics access to the consumer and making both tests and results easier to access globally
• Increased collaboration through cross-collaboration of multiple companies will create new product offerings in medical technology
  • Augmented and virtual reality (AR/VR) technology will help facilitate higher quality of collaboration and training
  • Collaborations between device companies and healthcare developers have focused on core competencies for new solutions

• Hememics Biotechnologies
  • Private Fundraise
    • Interested in raising funds from accredited investors
  • Quick Signup TBD
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💭  Looking into

What are the common features of POC technologies authorized for emergency use for nucleic acid, antigen, and antibody tests?

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• Companies developing Point-of-Care (POC) Diagnostics solutions:
  • Hememics (US): point of care platform to rapidly identify infectious disease pathogens, tests for up to 17 different pathogens, provides real-time diagnostics to healthcare workers.
  • iFirst Medical Technologies (Singapore): point of care diagnostic device that integrates with iOS, uses a cartridge system to analyze samples, tracks a user’s coagulation profile in real-time and shares it over the cloud.
  • Bioloom (Cyprus): develops high sensitivity biochips using proprietary plasmonic interferometric sensors, currently developing biochips for the diagnosis of anaphylaxis and sepsis.
  • Biosensorix (Singapore): focuses on the development of low-cost and effective point of care solutions, three solutions include ELLI, StackPad and BioPen.
  • Docturnal (India): specializes in the development of a non-invasive point of care diagnostic solution for early and proactive detection of TB biomarkers and symptoms.
• Point-of-Care (POC) diagnostics use biosensors, microfluidics, and lab-on-chips, facilitate low cost and rapid diagnostics without requiring the extensive sample treatment processes used by laboratories.
• Pandemic has shifted global research and development of PoC diagnostics due to their benefits with significant investments towards startups creating these solutions.
• Startups utilize the abundant mobile phone market to develop PoC diagnostic solutions that use phone hardware for diagnostics which creates a more affordable self-diagnostic healthcare ecosystem.
• Biochip and biosensor manufacturers are creating more efficient manufacturing methods as they find use in healthcare applications such as wearables and Point-of-Care.
• Point-of-care testing focuses on the use of biosensors and advanced lab-on-chip systems to run lab equivalent tests and determine results.
• Point-of-Care testing aims to be rapid while being effective and affordable to the mass market which is difficult with lab-on-chip-based testing devices.
• WHO reports an estimated 1.4 million people died from tuberculosis (TB) in 2019.
• Doctunal’s solutions aim to solve the challenges of accessible and affordable tuberculosis care in developing countries.

• Point-of-care (POC) diagnostics review in pandemic age
  • Overview of developments in POC diagnostics during the COVID-19 pandemic
  • Holistic POC ecosystem framework, focusing on technological and non-technological points of interest
    • Design choices in assay chemistry, microfluidics, and instrumentation towards nucleic acid and protein detection for SARS-CoV-2
    • Developments that supported rapid development, scale-up, and deployment of POC devices outside the lab
  • Common features in POC technologies authorized for emergency use for nucleic acid, antigen, and antibody tests, and how they fit into four distinct POC use cases
  • Implications for future pandemics, infectious disease monitoring, and digital health
• Relevant figures:
  • Figure 1: Overview of the POC diagnostics ecosystem in a pandemic age
  • Figure 2: Images of selected industry examples of SARS-CoV-2 POC tests
  • Figure 3: Timeline of over-the-counter tests approved by the FDA from 1990 to 2020
  • Figure 4: Overview of in-vitro diagnostics (IVD) that have received FDA Emergency Use Authorization (EUA)
  • Figure 5: Relationships between company history, government funding, and time to first EUA
  • Figure 6: POC use cases, decoupling cost from infrastructure
  • Figure 7: Breaking down POC diagnostic platforms that have received FDA EUA by their use case
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• Relevant info from webpage:
  • Point-of-care (POC) diagnostics is expected to be one of the fastest-growing major in-vitro diagnostics (IVD) market segments in Asia-Pacific (APAC).
    • EIU Healthcare estimates the APAC POC diagnostics market to increase by 6.4% annually on average during the 2019-2024 forecast period.
    • The report highlights the decentralisation trend in testing, the regional solutions to improve healthcare access, and the growing role of POC testing in driving regional disease elimination and control goals.
    • The report offers deep insights into the rise of domestic IVD players amid the growing needs for POC testing.
    • IVD companies will have to adapt their market strategy to meet the region’s increased demand for affordable POC tests.
  • The report covers various topics related to POC testing, such as the top three fastest-growing market segments in POC diagnostics (2019-2024), growth outlook for POC testing for vector-based diseases (VBD) such as dengue and malaria, and connected blood glucose testing country spotlight.
  • The report also provides a malaria POC testing country spotlight that discusses how public-private partnerships are driving disease elimination by 2030.
  • The report mentions domestic POC diagnostics players to watch.
  • IVD Gateway is a go-to source for tracking and understanding market size, share, and trends in IVD, providing granular break-out of data and comprehensive coverage of international and domestic suppliers’ brand share across Asia, Europe, Latin America, and the Middle East.

• Point of care (POC) testing
  • Medical testing performed outside of a laboratory setting
  • Can be carried out in a variety of locations by healthcare providers
  • POC testing devices are handheld electronics or molecular collection tools
  • Examples of POC test tools include blood glucose monitors, thermometers, home pregnancy tests, and rapid strep tests
  • Useful for value-based healthcare where there is a need for more convenient diagnosis, accurate monitoring, early detection and the prevention and management of chronic conditions
  • Rapid strep tests can allow a patient to receive earlier treatment and avoid further risks associated with misdiagnosis.
• POC testing technology
  • POC technologies offer the potential to improve the management of various diseases and conditions
  • Adoption of smartphones and other mobile devices by clinicians, consumers and employees is enabling providers to bring about major changes in how they work.
• Benefits and drawbacks
  • Portability and accessibility of POC testing devices have brought several advantages
  • However, patients need to be well-educated on device directions and implications when healthcare is placed in patient’s hands
  • Medical devices need to be restricted to only the intended use and monitored for misinterpretation or inconsistencies
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💭  Looking into

What is the best Point of Care (POC) diagnostic and evaluation product for business, financial, and growth levers, for the selection and partnering of med-tech start-ups?