FDA
17/6
During this unprecedented public health emergency, the Agency has received an exceedingly high volume of EUA requests and is working as quickly as possible to review each request. There are hundreds of pre-EUA and EUA requests for COVID-19 tests under review and FDA continues to receive new submissions on a daily basis. To address this high volume of work, we have brought in additional scientific review staff to double the number of teams working on submissions
FDA prioritizes EUA requests based on several factors that include, but are not limited to, the public health need of the product (e.g., point-of-care; high throughput), the extent to which the product would serve a significant unmet medical need (e.g., at-home specimen collection; at-home testing), and the availability and adequacy of the information concerning the likelihood that the product may be safe and effective in preventing, treating, or diagnosing the condition, as well as the availability of the product (e.g., the quantity and manufacturing capacity).
FDA strives to review Pre-EUA and EUA requests as quickly as we can. FDA will communicate with each sponsor regarding its pre-EUA or EUA request as soon as possible. The review team will be in contact with you when their review is complete or if there are questions.
Som man kan lese i andre avsitt prioriteres godkjenningene etter hvilken helse gevinst de gir. De blir også sortert etter når produktet kan være tilgjengelig i markedet. Leser dette som fordel til DD sin hurtigtest.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
Tenker og kun poste relevante linker på denne tråden
During this unprecedented public health emergency, the Agency has received an exceedingly high volume of EUA requests and is working as quickly as possible to review each request. There are hundreds of pre-EUA and EUA requests for COVID-19 tests under review and FDA continues to receive new submissions on a daily basis. To address this high volume of work, we have brought in additional scientific review staff to double the number of teams working on submissions
FDA prioritizes EUA requests based on several factors that include, but are not limited to, the public health need of the product (e.g., point-of-care; high throughput), the extent to which the product would serve a significant unmet medical need (e.g., at-home specimen collection; at-home testing), and the availability and adequacy of the information concerning the likelihood that the product may be safe and effective in preventing, treating, or diagnosing the condition, as well as the availability of the product (e.g., the quantity and manufacturing capacity).
FDA strives to review Pre-EUA and EUA requests as quickly as we can. FDA will communicate with each sponsor regarding its pre-EUA or EUA request as soon as possible. The review team will be in contact with you when their review is complete or if there are questions.
Som man kan lese i andre avsitt prioriteres godkjenningene etter hvilken helse gevinst de gir. De blir også sortert etter når produktet kan være tilgjengelig i markedet. Leser dette som fordel til DD sin hurtigtest.
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
Tenker og kun poste relevante linker på denne tråden
Redigert 20.01.2021 kl 00:10
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Detaljert om godkjente tester:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas
Daglig oppdatering fra FDA:
https://www.fda.gov/news-events/fda-newsroom/press-announcements
Digid på twitter:
https://twitter.com/digid_AG?lang=en
Lifecare på newsweb (børsmeldinger):
https://newsweb.oslobors.no/search?category=&issuer=12646&fromDate=&toDate=&market=&messageTitle=
https://www.lifecare.no/ og https://digid.com/
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas
Daglig oppdatering fra FDA:
https://www.fda.gov/news-events/fda-newsroom/press-announcements
Digid på twitter:
https://twitter.com/digid_AG?lang=en
Lifecare på newsweb (børsmeldinger):
https://newsweb.oslobors.no/search?category=&issuer=12646&fromDate=&toDate=&market=&messageTitle=
https://www.lifecare.no/ og https://digid.com/
Redigert 27.06.2020 kl 08:33
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Fox news! DD`s sterkeste konkurrent. En bør se denne videoen. Nevnes at FDA ser på godkjennig av denne testen: https://www.youtube.com/watch?v=sxJSMuHG1Fo
Abbot sin test:
False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis
“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.
https://khn.org/news/abbott-rapid-test-problems-grow-fda-standards-on-covid-tests-under-fire/
False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis
“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.
https://khn.org/news/abbott-rapid-test-problems-grow-fda-standards-on-covid-tests-under-fire/
Sofia 2. Også konkurrent til DD
“The test is about 85% sensitive. So, let’s say a hundred people come into a doctor’s office who have COVID-19, eighty-five of them are going to be able to be tested positive with this test very quickly. It’s a cheap test. It’ll probably be about five dollars a test and you can get a result within five minutes … you’re getting a very fast result and you can start to take action immediately.
https://www.darkdaily.com/fda-issues-its-first-emergency-use-authorization-for-an-antigen-based-diagnostic-as-top-ivd-manufacturers-race-to-supply-medical-laboratories-with-covid-19-tests/
https://finance.yahoo.com/news/bull-day-quidel-qdel-094709996.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAADu3QyqYBobVWSTLTMFXFW54hjfcfB2N6D0QdpAuaLaxHNoJDDuQt2JBOXGGEGRrP6LK-YOkF4n3bGxxk5Lda6YztTyPMG8jPmK-lBKKgZ1ciXTckmRg-Lh5LhI3NsEf5kaWtcTenYBlIHH1vzJBH0Xr1DNLRWn7taSz2_TvzNnQ
“The test is about 85% sensitive. So, let’s say a hundred people come into a doctor’s office who have COVID-19, eighty-five of them are going to be able to be tested positive with this test very quickly. It’s a cheap test. It’ll probably be about five dollars a test and you can get a result within five minutes … you’re getting a very fast result and you can start to take action immediately.
https://www.darkdaily.com/fda-issues-its-first-emergency-use-authorization-for-an-antigen-based-diagnostic-as-top-ivd-manufacturers-race-to-supply-medical-laboratories-with-covid-19-tests/
https://finance.yahoo.com/news/bull-day-quidel-qdel-094709996.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAADu3QyqYBobVWSTLTMFXFW54hjfcfB2N6D0QdpAuaLaxHNoJDDuQt2JBOXGGEGRrP6LK-YOkF4n3bGxxk5Lda6YztTyPMG8jPmK-lBKKgZ1ciXTckmRg-Lh5LhI3NsEf5kaWtcTenYBlIHH1vzJBH0Xr1DNLRWn7taSz2_TvzNnQ
Siste aksjonærliste. Man må registrere seg for og se den (.jpg kan ikke klippes og limes) :
https://s3.eu-west-1.amazonaws.com/uploads.euw1.cloud.rocket.chat/8f4gAGLLtLXhBBEut/uploads/2c577W8ssuESNFfWp/c6xjFYwLithyX65vT/fL8bPEFkat49boJZN?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=AKIAINPNEZDMKIWTQJQQ%2F20200627%2Feu-west-1%2Fs3%2Faws4_request&X-Amz-Date=20200627T064959Z&X-Amz-Expires=120&X-Amz-Signature=976d99b8f9adafbce5c5874bc11c06308d59af1152369ea6cced0b2622483775&X-Amz-SignedHeaders=host&response-content-disposition=inline%3B%20filename%3D%22LIFE.JPG%22
https://s3.eu-west-1.amazonaws.com/uploads.euw1.cloud.rocket.chat/8f4gAGLLtLXhBBEut/uploads/2c577W8ssuESNFfWp/c6xjFYwLithyX65vT/fL8bPEFkat49boJZN?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=AKIAINPNEZDMKIWTQJQQ%2F20200627%2Feu-west-1%2Fs3%2Faws4_request&X-Amz-Date=20200627T064959Z&X-Amz-Expires=120&X-Amz-Signature=976d99b8f9adafbce5c5874bc11c06308d59af1152369ea6cced0b2622483775&X-Amz-SignedHeaders=host&response-content-disposition=inline%3B%20filename%3D%22LIFE.JPG%22
Redigert 27.06.2020 kl 08:51
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Litt om markedet:
The global COVID-19 diagnostics market size was valued at USD 5.2 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 5.96% from 2021 to 2027.
https://www.grandviewresearch.com/industry-analysis/covid-19-diagnostics-market
The global COVID-19 diagnostics market size was valued at USD 5.2 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 5.96% from 2021 to 2027.
https://www.grandviewresearch.com/industry-analysis/covid-19-diagnostics-market
En veldig enkel og god forklaring på hvordan en antigen (anti body generator) test fungerer:
An antigen test for SARS-CoV-2 starts with a medical professional collecting a sample of mucus from the back of a persons throat or nose using a swab. They then dip the swab into a liquid to dissolve the mucus and release the virus.
The liquid is then applied to the surface of the test slide that is coated with antibodies. These antibodies are stuck to the slide and “grab onto” any coronavirus proteins that are in the sample.
https://theconversation.com/antigen-tests-for-covid-19-are-fast-and-easy-and-could-solve-the-coronavirus-testing-problem-despite-being-somewhat-inaccurate-137977
Weakness:
Because they look directly for evidence of the virus, there need to be a lot virus proteins available to stick to the antibodies to produce a detectable result.
Depending on the virus, qualitative antigen tests likely need a sample to contain many thousands of viral proteins in order to produce a positive test. If a sample doesn’t have enough virus or a person has a low-grade infection, the test might give a false negative result – and a sick person would get told they are uninfected.
Hvordan har DD løst dette?
An antigen test for SARS-CoV-2 starts with a medical professional collecting a sample of mucus from the back of a persons throat or nose using a swab. They then dip the swab into a liquid to dissolve the mucus and release the virus.
The liquid is then applied to the surface of the test slide that is coated with antibodies. These antibodies are stuck to the slide and “grab onto” any coronavirus proteins that are in the sample.
https://theconversation.com/antigen-tests-for-covid-19-are-fast-and-easy-and-could-solve-the-coronavirus-testing-problem-despite-being-somewhat-inaccurate-137977
Weakness:
Because they look directly for evidence of the virus, there need to be a lot virus proteins available to stick to the antibodies to produce a detectable result.
Depending on the virus, qualitative antigen tests likely need a sample to contain many thousands of viral proteins in order to produce a positive test. If a sample doesn’t have enough virus or a person has a low-grade infection, the test might give a false negative result – and a sick person would get told they are uninfected.
Hvordan har DD løst dette?
Redigert 27.06.2020 kl 09:04
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Er digid best i bransjen fordi deres test kan detektere selv den minste mengde virus?
Les: These nanomechanical spring bars made of silicon are extremely thin and can be bent by the application of even a tiny force
Micro-Electro-Mechanical Systems(MEMS)
The Digid Cantisense™ SARS-CoV-2 Test is based on cantilevers, which are integrated onto a microchip with the size of a fingernail. These nanomechanical spring bars made of silicon are extremely thin and can be bent by the application of even a tiny force. This makes them highly sensitive biochemical sensors. With the Digid Cantisense™ SARS-CoV-2 Test, the cantilevers are coated with a capture layer of antibodies. When applied to the chip, these antibodies bind any viruses contained in the test fluid. When the new coronavirus binds to the capture layer, changes in surface tension cause mechanical bending of thee cantilevers, which generates an electrical signal on the chip.
https://digid.com/en/new-5-minute-corona-virus-test-delivers-clear-results-on-infection/
Les: These nanomechanical spring bars made of silicon are extremely thin and can be bent by the application of even a tiny force
Micro-Electro-Mechanical Systems(MEMS)
The Digid Cantisense™ SARS-CoV-2 Test is based on cantilevers, which are integrated onto a microchip with the size of a fingernail. These nanomechanical spring bars made of silicon are extremely thin and can be bent by the application of even a tiny force. This makes them highly sensitive biochemical sensors. With the Digid Cantisense™ SARS-CoV-2 Test, the cantilevers are coated with a capture layer of antibodies. When applied to the chip, these antibodies bind any viruses contained in the test fluid. When the new coronavirus binds to the capture layer, changes in surface tension cause mechanical bending of thee cantilevers, which generates an electrical signal on the chip.
https://digid.com/en/new-5-minute-corona-virus-test-delivers-clear-results-on-infection/
Redigert 27.06.2020 kl 09:13
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WHO
The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.
The consolidated investment case calls for US$31.3 billion over the next 12 months[1]. US$3.4 billion has been contributed to date, resulting in a funding gap of US$27.9 billion, of which $13.7 billion is urgently needed.
Pillar plans published today show a path to the accelerated development, equitable allocation, and scaled up delivery of 500 million tests to LMIC’s by mid-2021, 245 million courses of treatments to LMICs by mid-2021, and 2 billion vaccine doses, of which 1 billion will be purchased for LMICs, by the end of 2021.
https://www.who.int/news-room/detail/26-06-2020-act-accelerator-update
Hvis DD sin test er veldig nøyakig og billig vil WHO stå langt fremme i køen for og sikre seg mange eksemplar.
The ACT-Accelerator has four areas of work: diagnostics, therapeutics, vaccines and the health system connector. Cross-cutting all of these is the workstream on Access & Allocation.
The consolidated investment case calls for US$31.3 billion over the next 12 months[1]. US$3.4 billion has been contributed to date, resulting in a funding gap of US$27.9 billion, of which $13.7 billion is urgently needed.
Pillar plans published today show a path to the accelerated development, equitable allocation, and scaled up delivery of 500 million tests to LMIC’s by mid-2021, 245 million courses of treatments to LMICs by mid-2021, and 2 billion vaccine doses, of which 1 billion will be purchased for LMICs, by the end of 2021.
https://www.who.int/news-room/detail/26-06-2020-act-accelerator-update
Hvis DD sin test er veldig nøyakig og billig vil WHO stå langt fremme i køen for og sikre seg mange eksemplar.
Redigert 27.06.2020 kl 09:36
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Ble veldig positivt overrsaket da jeg gravde litt i arbeidet Dr Konstantin Kloppstech (DD/LC) har utført.
Power point: https://simul-europe.com/2018/attd/Files/(andreas.pfuetzner@pfuetzner-mainz.com)ePoster%20NIA.pdf
Presentasjonen beskriver hvor mye mer nøyaktig deres nanosensor er kontra enzyme-linked immunosorbent assay (ELISA).
Ser at linken ikke fungerer ved å trykke direkte på den så klipp og lim hele adressen.
The ELISA reference method was shown to have a 100 % specificity within an observed linear detection range
from 10 ng/mL to 1000 ng/mL With similar specificity, the linear detection range of the NIA was shown to be
between 0.01 ng/mL to 1 ng/mL, i.e. the NIA was 1000fold more sensitive than the reference ELISA. Minor
unspecific binding of IgG was observed with the NIA technology at chicken IgG concentrations > 1000 ng/mL
"ELISAs are one of the most sensitive immunoassays available. The typical detection range for an ELISA is 0.1 to 1 fmole or 0.01 ng to 0.1 ng"
Forklaring om Elisa deteksjon: https://www.enzolifesciences.com/science-center/technotes/2019/september/why-are-sensitivity-and-specificity-important-parameters-for-an-elisa?/
Her står det altså "the NIA was 1000fold more sensitive than the reference ELISA"
NIA:
NANO-IMMUNO-ASSAY (NIA) - A CANTILEVER-BASED
NANOSENSOR TECHNOLOGY FOR POINT-OF-CARE
MEASUREMENT OF PROTEINS IN BIOLOGICAL SAMPLES
In our proof-of-concept experiment, the NIA in comparison to the classic ELISA was shown to be substantially
more sensitive, less time and resource consuming. With the NIA it is possible to determine the analyte-binding
directly within minutes and without any further labeling requirement. In addition, the small size of the NIA sensors
allows for integration into Lab-on-a-Chip technologies, which will enable point-of-care testing with a laboratory
quality level.
BULL
Power point: https://simul-europe.com/2018/attd/Files/(andreas.pfuetzner@pfuetzner-mainz.com)ePoster%20NIA.pdf
Presentasjonen beskriver hvor mye mer nøyaktig deres nanosensor er kontra enzyme-linked immunosorbent assay (ELISA).
Ser at linken ikke fungerer ved å trykke direkte på den så klipp og lim hele adressen.
The ELISA reference method was shown to have a 100 % specificity within an observed linear detection range
from 10 ng/mL to 1000 ng/mL With similar specificity, the linear detection range of the NIA was shown to be
between 0.01 ng/mL to 1 ng/mL, i.e. the NIA was 1000fold more sensitive than the reference ELISA. Minor
unspecific binding of IgG was observed with the NIA technology at chicken IgG concentrations > 1000 ng/mL
"ELISAs are one of the most sensitive immunoassays available. The typical detection range for an ELISA is 0.1 to 1 fmole or 0.01 ng to 0.1 ng"
Forklaring om Elisa deteksjon: https://www.enzolifesciences.com/science-center/technotes/2019/september/why-are-sensitivity-and-specificity-important-parameters-for-an-elisa?/
Her står det altså "the NIA was 1000fold more sensitive than the reference ELISA"
NIA:
NANO-IMMUNO-ASSAY (NIA) - A CANTILEVER-BASED
NANOSENSOR TECHNOLOGY FOR POINT-OF-CARE
MEASUREMENT OF PROTEINS IN BIOLOGICAL SAMPLES
In our proof-of-concept experiment, the NIA in comparison to the classic ELISA was shown to be substantially
more sensitive, less time and resource consuming. With the NIA it is possible to determine the analyte-binding
directly within minutes and without any further labeling requirement. In addition, the small size of the NIA sensors
allows for integration into Lab-on-a-Chip technologies, which will enable point-of-care testing with a laboratory
quality level.
BULL
Redigert 28.06.2020 kl 12:10
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