Post by icemandios on Mar 20, 2020 13:27:58 GMT
Point-of-Care Coronavirus Test From Credo Diagnostics Biomedical Gets CE Mark
Mar 18, 2020
| staff reporter
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NEW YORK – Credo Diagnostics Biomedical announced on Tuesday it has obtained CE mark for an assay to detect SARS-CoV-2, the virus that causes coronavirus disease COVID-19. The test runs on the firm's point-of-care instrument and is now commercially available on countries accepting the CE designation.
The Credo platform, called VitaPCR, performs real-time PCR to detect pathogens in 20 minutes, with one minute of hands-on time. As previously reported, the system needs minimal training to run and involves no additional equipment.
Winston Wong, chairman of Singapore-based Credo, said that better tools are currently needed at front-line locations, like airports. "Rapid and accurate molecular screening [for the] COVID-19 strain will better help contain the virus and allow early actions to be taken, thus preventing tragedies," Wong said.
Todos Medical Inks Agreement to Distribute Coronavirus POC Test in US, Israel
Mar 19, 2020
| staff reporter
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Due an error by Todos Medical, 3D Medicines was incorrectly identified as 3D Biomedicine Science & Technology in an earlier version of this article. We have corrected the company name.
NEW YORK – Todos Medical said Thursday it has inked an exclusive agreement with Gibraltar Brothers & Associates to distribute a rapid point-of-care kit in the US and Israel that detects antibodies against SARS-CoV-2, the coronavirus that causes COVID-19.
Gibraltar Brothers is a US-based subsidiary of China-based Shanghai Liangrun Biomedicine Technology, the test supplier.
Financial and other terms of the agreement were not disclosed.
The test, called Colloidal Gold, which uses colloidal gold immunochromatography, can provide results in less than 10 minutes at the point of care, using blood from a fingerprick, according to Rehovot, Israel-based Todos.
The test has demonstrated 90.4 percent sensitivity and 100 percent specificity in a Chinese clinical trial located in Wuhan where the coronavirus disease COVID-19 outbreak originated. Investigators evaluated Colloidal Gold using 188 blood samples obtained from patients with clinically confirmed COVID-19 and 182 non-SARS-CoV-2 infected patients.
The test has received CE marking and Chinese National Medical Products Administration (NMPA) approval to detect the coronavirus, Todos said.
It anticipates pursuing US Food and Drug Administration Emergency Use Authorization for the test.
Jorge Leon, chief medical advisor for Todos, said that the "IgM antibody response to the SARS-CoV-2 virus appears at days [five to six] after infection, showing recent exposure to the virus, and lasts for up to three weeks."
He added that it "is an important test to increase the window of diagnostic sensitivity of true positive cases since molecular test…is not always positive in some patients during the early course of infection." The IgG antibody response peaks at day 21 and lasts for years, indicating the patient was infected with the virus.
Shanghai Liangrun Biomedicine has shipped test kits to Todos for validation. The Chinese firm has 500,000 Colloidal Gold test kits in stock and has indicated it can manufacture up to 300,000 test kits per day to help meet demand in the US. Todos said it will validate the assay in the US in the coming weeks in preparation for initial commercial launch as a laboratory-developed test. It will use Provista Diagnostics' lab in Alpharetta, Georgia to conduct validation activities.
Todos said that the rapid test could be used to triage and quarantine patients as quickly as possible after detection. A nurse practitioner can conduct the test in a doctor’s office or clinic, the firm said, but its distribution focus will be on nursing homes and senior care centers.
Todos noted that it has inked an exclusive option agreement to acquire Provista and anticipates the transaction will close in the second quarter of this year.
Because Colloidal Gold tests for antibodies to SARS-CoV-2, the test will complement a nucleic acid test that Todos is also validating, the firm said.
Todos Medical said Tuesday it has inked a non-exclusive agreement for distribution in the US and Israel of 3D Medicines' 3DMed 2019-nCoV Detection Kit, 3DMed 2019-nCoV & Flu A/B Detection Kit, and Andis350 3DMed Automated Solution real-time PCR machine.
Mesa Biotech Point-of-Care Coronavirus Test Development Receives $561,330 From BARDA
Mar 18, 2020
| staff reporter
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NEW YORK – Mesa Biotech has been awarded $561,330 from the Biomedical Advanced Research and Development Authority to support development and commercialization of a point-of-care diagnostic test for SARS-CoV-2, the pathogen that causes coronavirus disease COVID-19.
The firm's test runs on its Accula platform, requires minimal sample handling, and produces a result in 30 minutes. An influenza test on the system was previously cleared by the US Food and Drug Administration and CLIA waived.
The funding was awarded through the EZ-BAA mechanism of BARDA, which is part of the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, or ASPR.
BARDA will provide San Diego-based Mesa Biotech with the funding as well as technical expertise, with the intention that the firm attain Emergency Use Authorization from the US Food and Drug Administration in two months. Mesa has previously disclosed that it has been working on a SARS-CoV-2 test and is conducting clinical validations through a collaboration in China.
"Diagnostics are a critical need in the overall strategy to fight this newest global public health threat," said Rick Bright, director of BARDA, in a statement. "We need increased testing capacity in the US to rapidly identify, isolate, and treat those infected with COVID-19 in order to limit transmission of the virus, and we need those tests as close to the patients as possible."
Mesa's test is the fourth COVID-19 molecular diagnostic to receive development funding from BARDA. Others include Hologic, Qiagen, and DiaSorin Molecular.
The Accula platform is distributed exclusively in the US by Sekisui, under the brand name Silaris.
Mar 18, 2020
| staff reporter
Save for later
NEW YORK – Credo Diagnostics Biomedical announced on Tuesday it has obtained CE mark for an assay to detect SARS-CoV-2, the virus that causes coronavirus disease COVID-19. The test runs on the firm's point-of-care instrument and is now commercially available on countries accepting the CE designation.
The Credo platform, called VitaPCR, performs real-time PCR to detect pathogens in 20 minutes, with one minute of hands-on time. As previously reported, the system needs minimal training to run and involves no additional equipment.
Winston Wong, chairman of Singapore-based Credo, said that better tools are currently needed at front-line locations, like airports. "Rapid and accurate molecular screening [for the] COVID-19 strain will better help contain the virus and allow early actions to be taken, thus preventing tragedies," Wong said.
The VitaPCR SARS-CoV-2 Assay is now also pending Emergency Use Authorization from the US Food and Drug Administration and Emergency Use Listing from the World Health Organization, the firm noted in a statement.
Todos Medical Inks Agreement to Distribute Coronavirus POC Test in US, Israel
Mar 19, 2020
| staff reporter
Save for later
Due an error by Todos Medical, 3D Medicines was incorrectly identified as 3D Biomedicine Science & Technology in an earlier version of this article. We have corrected the company name.
NEW YORK – Todos Medical said Thursday it has inked an exclusive agreement with Gibraltar Brothers & Associates to distribute a rapid point-of-care kit in the US and Israel that detects antibodies against SARS-CoV-2, the coronavirus that causes COVID-19.
Gibraltar Brothers is a US-based subsidiary of China-based Shanghai Liangrun Biomedicine Technology, the test supplier.
Financial and other terms of the agreement were not disclosed.
The test, called Colloidal Gold, which uses colloidal gold immunochromatography, can provide results in less than 10 minutes at the point of care, using blood from a fingerprick, according to Rehovot, Israel-based Todos.
The test has demonstrated 90.4 percent sensitivity and 100 percent specificity in a Chinese clinical trial located in Wuhan where the coronavirus disease COVID-19 outbreak originated. Investigators evaluated Colloidal Gold using 188 blood samples obtained from patients with clinically confirmed COVID-19 and 182 non-SARS-CoV-2 infected patients.
The test has received CE marking and Chinese National Medical Products Administration (NMPA) approval to detect the coronavirus, Todos said.
It anticipates pursuing US Food and Drug Administration Emergency Use Authorization for the test.
Jorge Leon, chief medical advisor for Todos, said that the "IgM antibody response to the SARS-CoV-2 virus appears at days [five to six] after infection, showing recent exposure to the virus, and lasts for up to three weeks."
He added that it "is an important test to increase the window of diagnostic sensitivity of true positive cases since molecular test…is not always positive in some patients during the early course of infection." The IgG antibody response peaks at day 21 and lasts for years, indicating the patient was infected with the virus.
Shanghai Liangrun Biomedicine has shipped test kits to Todos for validation. The Chinese firm has 500,000 Colloidal Gold test kits in stock and has indicated it can manufacture up to 300,000 test kits per day to help meet demand in the US. Todos said it will validate the assay in the US in the coming weeks in preparation for initial commercial launch as a laboratory-developed test. It will use Provista Diagnostics' lab in Alpharetta, Georgia to conduct validation activities.
Todos said that the rapid test could be used to triage and quarantine patients as quickly as possible after detection. A nurse practitioner can conduct the test in a doctor’s office or clinic, the firm said, but its distribution focus will be on nursing homes and senior care centers.
Todos noted that it has inked an exclusive option agreement to acquire Provista and anticipates the transaction will close in the second quarter of this year.
Because Colloidal Gold tests for antibodies to SARS-CoV-2, the test will complement a nucleic acid test that Todos is also validating, the firm said.
Todos Medical said Tuesday it has inked a non-exclusive agreement for distribution in the US and Israel of 3D Medicines' 3DMed 2019-nCoV Detection Kit, 3DMed 2019-nCoV & Flu A/B Detection Kit, and Andis350 3DMed Automated Solution real-time PCR machine.
Mesa Biotech Point-of-Care Coronavirus Test Development Receives $561,330 From BARDA
Mar 18, 2020
| staff reporter
Save for later
NEW YORK – Mesa Biotech has been awarded $561,330 from the Biomedical Advanced Research and Development Authority to support development and commercialization of a point-of-care diagnostic test for SARS-CoV-2, the pathogen that causes coronavirus disease COVID-19.
The firm's test runs on its Accula platform, requires minimal sample handling, and produces a result in 30 minutes. An influenza test on the system was previously cleared by the US Food and Drug Administration and CLIA waived.
The funding was awarded through the EZ-BAA mechanism of BARDA, which is part of the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, or ASPR.
BARDA will provide San Diego-based Mesa Biotech with the funding as well as technical expertise, with the intention that the firm attain Emergency Use Authorization from the US Food and Drug Administration in two months. Mesa has previously disclosed that it has been working on a SARS-CoV-2 test and is conducting clinical validations through a collaboration in China.
"Diagnostics are a critical need in the overall strategy to fight this newest global public health threat," said Rick Bright, director of BARDA, in a statement. "We need increased testing capacity in the US to rapidly identify, isolate, and treat those infected with COVID-19 in order to limit transmission of the virus, and we need those tests as close to the patients as possible."
Mesa's test is the fourth COVID-19 molecular diagnostic to receive development funding from BARDA. Others include Hologic, Qiagen, and DiaSorin Molecular.
The Accula platform is distributed exclusively in the US by Sekisui, under the brand name Silaris.