Severe acute respiratory syndrome-related coronavirus

Roche announces the filing for FDA Emergency Use Authorization for SARS-CoV-2 Rapid Antigen Test, allowing healthcare professionals to make fast decisions at the point of care

Retrieved on: 
Monday, February 8, 2021

The test is designed to help healthcare professionals quickly identify a SARS-CoV-2 infection, typically in 15 minutes, in people exhibiting symptoms of the virus.

Key Points: 
  • The test is designed to help healthcare professionals quickly identify a SARS-CoV-2 infection, typically in 15 minutes, in people exhibiting symptoms of the virus.
  • The test is highly beneficial where timely decisions are needed and PCR tests are not readily available.
  • "This new rapid antigen test will provide a much needed resource to the healthcare system, as broad access to testing will be critical for re-opening our society."
  • This test will be a valuable addition to the comprehensive Roche diagnostic portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point of care.

Oxford Immunotec Enters a Memorandum of Understanding (MOU) with GC MS (Green Cross Medical Science Corp. – South Korea) to Market the T-SPOT® Discovery SARS-CoV-2 Kit, for the Measurement of the T Cell Immune Response to SARS-CoV-2 Infection, in South

Retrieved on: 
Monday, February 8, 2021

Under this agreement, GC MS will market/sell, MESDIA will import, and Oxford Immunotec Korea will provide overall support for the T-SPOT Discovery SARS-CoV-2 kit.

Key Points: 
  • Under this agreement, GC MS will market/sell, MESDIA will import, and Oxford Immunotec Korea will provide overall support for the T-SPOT Discovery SARS-CoV-2 kit.
  • GC MS is an industry leader in the field of medical devices and diagnostic reagents, and a member of the GC Pharmaceutical companies, in South Korea.
  • T-SPOT Discovery SARS-CoV-2 will enable them to add a research test to measure the T cell response to SARS-CoV-2 infection to their offering.
  • Walt Ling, VP commercial APAC for Oxford Immunotec said, We are delighted to work in partnership with GC MS.

How Biotech Developers Are Working Towards New Diagnostic Solutions to Help Combat Covid-19

Retrieved on: 
Monday, February 8, 2021

In a recent US study ,the presence of SARS-CoV-2-specific effector T-cells is likely a predictor of a person's ability to recover from severe COVID-19.

Key Points: 
  • In a recent US study ,the presence of SARS-CoV-2-specific effector T-cells is likely a predictor of a person's ability to recover from severe COVID-19.
  • Diagnostic solutions represented a whopping 111.1% growth year-over-year, with $2.4 billion in COVID-19 testing revenue boosting that segment to more than $4.3 billion in sales.
  • Abbott has delivered more than 400 million COVID-19 diagnostic tests since the global health crisis began, with 300 million in Q4 2020 alone.
  • Abbott's two tests are its BinaxNow rapid antigen test and its international counterpart, the PanBio COVID-19 Ag rapid diagnostic.

How Biotech Developers Are Working Towards New Diagnostic Solutions to Help Combat Covid-19

Retrieved on: 
Monday, February 8, 2021

In a recent US study ,the presence of SARS-CoV-2-specific effector T-cells is likely a predictor of a person's ability to recover from severe COVID-19.

Key Points: 
  • In a recent US study ,the presence of SARS-CoV-2-specific effector T-cells is likely a predictor of a person's ability to recover from severe COVID-19.
  • Diagnostic solutions represented a whopping 111.1% growth year-over-year, with $2.4 billion in COVID-19 testing revenue boosting that segment to more than $4.3 billion in sales.
  • Abbott has delivered more than 400 million COVID-19 diagnostic tests since the global health crisis began, with 300 million in Q4 2020 alone.
  • Abbott's two tests are its BinaxNow rapid antigen test and its international counterpart, the PanBio COVID-19 Ag rapid diagnostic.

Kantaro and Atrys Health Partnership Expand Global Footprint of Quantitative COVID-19 Antibody Tests in Europe and South America

Retrieved on: 
Monday, February 8, 2021

Atrys Health will offer COVID-SeroKlir and COVID-SeroIndex, Kantaro's quantitative SARS-CoV-2 IgG antibody test kits, in select European and South American territories, including Spain, Portugal, Colombia, Brazil, Peru and Chile.

Key Points: 
  • Atrys Health will offer COVID-SeroKlir and COVID-SeroIndex, Kantaro's quantitative SARS-CoV-2 IgG antibody test kits, in select European and South American territories, including Spain, Portugal, Colombia, Brazil, Peru and Chile.
  • Atrys Health is a distributor for Kantaro quantitative antibody tests in select European and South American territories.
  • This agreement represents another critical step forward in bringing the Kantaro quantitative antibody tests to doctors, patients and researchers in regions affected by COVID-19," said Sara Barrington, Kantaro's chief commercial officer.
  • Isabel Lozano, CEOof Atrys Health, said: "Our partnership with Kantaro diversifies and widens our portfolio of diagnostics at the forefront of innovation.

Kantaro and Atrys Health Partnership Expand Global Footprint of Quantitative COVID-19 Antibody Tests in Europe and South America

Retrieved on: 
Monday, February 8, 2021

Atrys Health will offer COVID-SeroKlir and COVID-SeroIndex, Kantaro's quantitative SARS-CoV-2 IgG antibody test kits, in select European and South American territories, including Spain, Portugal, Colombia, Brazil, Peru and Chile.

Key Points: 
  • Atrys Health will offer COVID-SeroKlir and COVID-SeroIndex, Kantaro's quantitative SARS-CoV-2 IgG antibody test kits, in select European and South American territories, including Spain, Portugal, Colombia, Brazil, Peru and Chile.
  • This agreement represents another critical step forward in bringing the Kantaro quantitative antibody tests to doctors, patients and researchers in regions affected by COVID-19," said Sara Barrington, Kantaro's chief commercial officer.
  • Isabel Lozano, CEOof Atrys Health, said: "Our partnership with Kantaro diversifies and widens our portfolio of diagnostics at the forefront of innovation.
  • We humbly embrace the opportunity to make the Kantaro quantitative antibody testsavailableto our customers in Europe and South America and bepart of the globaleffort to increase testing and begin to recover from the COVID-19 pandemic."

Veru Reports Positive Phase 2 Clinical Results of VERU-111 in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome

Retrieved on: 
Monday, February 8, 2021

Veru conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for Acute Respiratory Distress Syndrome (ARDS).

Key Points: 
  • Veru conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for Acute Respiratory Distress Syndrome (ARDS).
  • Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled.
  • It is expected that the Phase 3 clinical trial will be conducted in approximately 200 hospitalized patients who have SARS-CoV-2 virus infection and are at high risk for Acute Respiratory Distress Syndrome.
  • Veru Inc. will host a conference call today at 9:00 am ET to discuss the positive clinical results from the Phase 2 trial.

Theragen Bio analyzes Korea's largest COVID-19 patient and coronavirus genomic data

Retrieved on: 
Tuesday, July 28, 2020

SEOUL, KOREA, July 28, 2020 - (ACN Newswire) - Theragen Bio is conducting joint research on developing a new coronavirus (COVID-19) genomic big data in collaboration with the Korea Research Institute of Chemical Technology (KRICT), Kyungpook National University Hospital, and the Daegu Metropolitan Government.

Key Points: 
  • SEOUL, KOREA, July 28, 2020 - (ACN Newswire) - Theragen Bio is conducting joint research on developing a new coronavirus (COVID-19) genomic big data in collaboration with the Korea Research Institute of Chemical Technology (KRICT), Kyungpook National University Hospital, and the Daegu Metropolitan Government.
  • The study will analyze the full genome of each patient and the SARS-CoV-2 virus using samples from approximately 1,000 COVID-19 patients in Daegu and Gyeongsangbuk-do provence, the largest coronavirus genomic analysis to be conducted in Korea.
  • Through this study, Theragen hopes to identify the infection correlation between patient genome and the SARS-CoV-2 virus genome, and apply it to future vaccine development.
  • Theragen identified the genetic correlation while establishing big data for SARS-CoV-2 mutations.

Pfizer and BioNTech Announce Agreement with the United Kingdom for 30 Million Doses of mRNA-based Vaccine Candidate against SARS-CoV-2

Retrieved on: 
Monday, July 20, 2020

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to clinical success and regulatory approval.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the United Kingdom to supply 30 million doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2, currently in development, subject to clinical success and regulatory approval.
  • Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses.
  • This agreement is a testament to our shared goal to have millions of doses of a vaccine against COVID-19 available before the end of the year.
  • We are in advanced discussions with multiple other government bodies and hope to announce additional supply agreements soon.

FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use

Retrieved on: 
Saturday, July 18, 2020

Quest is the first lab provider to receive FDA authorization for the technique for COVID-19 testing in the United States.

Key Points: 
  • Quest is the first lab provider to receive FDA authorization for the technique for COVID-19 testing in the United States.
  • With the new pooling EUA, the Quest Diagnostics SARS-CoV-2 RNA ("Quest SARS-CoV-2 rRT-PCR") test* may be used with pooled upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs).
  • "Pooled specimen testing is a proven technique that will help us to optimize testing capacity at this critical time for our country."
  • Yesterday, the FDA also granted three emergency use authorizations to Quest Diagnostics for the use of its Quest Diagnostics Self-Collection Kit with the Hologic Panther Fusion, Hologic Aptima and Roche cobas molecular platforms.