Coronavirus disease

Adaptive Biotechnologies Announces FDA Emergency Use Authorization for T-Detect™ COVID to Confirm Recent or Prior COVID-19 Infection

Retrieved on: 
Friday, March 5, 2021

People who have been unsure about a prior infection will now have another way to know if they had the virus, said Chad Robins, chief executive officer of Adaptive Biotechnologies.

Key Points: 
  • People who have been unsure about a prior infection will now have another way to know if they had the virus, said Chad Robins, chief executive officer of Adaptive Biotechnologies.
  • The authorization of T-Detect COVID represents a true breakthrough for patients and a pivotal milestone for the diagnostic testing paradigm.
  • EUA was based on a clinical validation study showing that T-Detect COVID demonstrated sensitivity of 97.1% from date of diagnosis using RT-PCR.
  • This is the first commercially available T-cell test that confirms recent or prior SARS-CoV-2 infections in people.

Humanigen to Present at Roth Conference

Retrieved on: 
Friday, March 5, 2021

Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.

Key Points: 
  • Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.
  • Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity.
  • In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders.
  • For more information, visit www.humanigen.com and follow Humanigen on LinkedIn , Twitter and Facebook .

Coronavirus (COVID-19) Update: FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test

Retrieved on: 
Friday, March 5, 2021

The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material fromSARS-CoV-2 virus present in the nostrils.

Key Points: 
  • The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material fromSARS-CoV-2 virus present in the nostrils.
  • The test is the first molecular test authorized for at-home use without a prescription.
  • "Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription.
  • The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public."

EMA Advises Use of AbCellera-Discovered Bamlanivimab, Alone or Together with Etesevimab, to Treat Confirmed COVID-19 Patients

Retrieved on: 
Friday, March 5, 2021

Several EU countries have authorized bamlanivimab, and the EMAs CHMP recommendation provides a mechanism for more EU countries to quickly access these antibodies to treat patients in need.

Key Points: 
  • Several EU countries have authorized bamlanivimab, and the EMAs CHMP recommendation provides a mechanism for more EU countries to quickly access these antibodies to treat patients in need.
  • The EMA reviewed Phase 2 and Phase 3 results from Eli Lilly and Companys (Lilly) BLAZE-1 trial to support the CHMP opinion.
  • Details regarding the CHMP opinion and Lillys plans to make COVID-19 therapies broadly available to patients can be found here .
  • It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

INmune Bio, Inc. Announces Fourth Quarter and Full Year 2020 Results and Provides Business Update

Retrieved on: 
Thursday, March 4, 2021

Our Phase 2 trial of Quellor for the treatment of for pulmonary complications patients with COVID-19 continues to enroll patients.

Key Points: 
  • Our Phase 2 trial of Quellor for the treatment of for pulmonary complications patients with COVID-19 continues to enroll patients.
  • Announced interim Phase 1b data demonstrating that XPro1595 decreased biomarkers of neuroinflammation and neurodegeneration, as measured by multiple analytic platforms in patients with Alzheimers disease.
  • As of December 31, 2020, the Company had cash and cash equivalents of approximately $22.0 million and no debt.
  • Our two platforms are beginning clinical trials and there cannot be any assurance of the success of these trials.

Oxford Immunotec Submits Emergency Use Authorization Request to the FDA and CE Marks T-SPOT®.COVID, a Test for the Detection of a Cell Mediated (T cell) Immune Response to SARS-CoV-2 Infection

Retrieved on: 
Thursday, March 4, 2021

In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection5.

Key Points: 
  • In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection5.
  • The T-SPOT.COVID test therefore complements results obtained by antibody serology to give a more comprehensive view of an individual's adaptive immune response to SARS-CoV-2 infection.
  • Phill Keefe, Senior VP, Product Design, Development and Delivery at Oxford Immunotec said, "T cells and antibodies are two arms of the adaptive immune response.
  • Our T-SPOT.COVID test is tailored specifically for the detection and measurement of an individual's T cell response to SARS-CoV-2 infection.

Oxford Immunotec Submits Emergency Use Authorization Request to the FDA and CE Marks T-SPOT®.COVID, a Test for the Detection of a Cell Mediated (T cell) Immune Response to SARS-CoV-2 Infection

Retrieved on: 
Thursday, March 4, 2021

In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection5.

Key Points: 
  • In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection5.
  • The T-SPOT.COVID test therefore complements results obtained by antibody serology to give a more comprehensive view of an individual's adaptive immune response to SARS-CoV-2 infection.
  • Phill Keefe, Senior VP, Product Design, Development and Delivery at Oxford Immunotec said, "T cells and antibodies are two arms of the adaptive immune response.
  • Our T-SPOT.COVID test is tailored specifically for the detection and measurement of an individual's T cell response to SARS-CoV-2 infection.

Study Shows SARS-CoV-2 Virus Not Detected in Human Semen

Retrieved on: 
Thursday, March 4, 2021

Cryos International Sperm and Egg Bank announced the results of a seven-month long study on the presence of the SARS-CoV-2 virus in human semen.

Key Points: 
  • Cryos International Sperm and Egg Bank announced the results of a seven-month long study on the presence of the SARS-CoV-2 virus in human semen.
  • The study was approved by the Western Institutional Review Board and is published here in the Journal of Assisted Reproduction and Genetics.
  • Study participants included 18 men who had tested positive for COVID-19 within 30 days of providing their ejaculate.
  • For over 30 years we have provided specialized reproductive products, excellent customer care, and personal consultation to our customers.

Statement from the Chief Public Health Officer of Canada on March 4, 2021

Retrieved on: 
Thursday, March 4, 2021

/CNW/ - I would like to thank the Canadian Armed Forces for its contribution to the national response to COVID-19.

Key Points: 
  • /CNW/ - I would like to thank the Canadian Armed Forces for its contribution to the national response to COVID-19.
  • Their expertise in logistics and their ability to rapidly deploy anywhere in Canada are key to our efforts, especially as vaccine supplies ramp-up in the coming weeks.
  • They also tell us, together with results of serological studies, that the vast majority of Canadians remain susceptible to COVID-19 .
  • Any easing of public health measures must be done slowly with enhanced testing, screening, and genomic analysis to detect variants of concern.

TurnSole Announces Regulatory Authority Approval and Subsequent Initiation of a Phase Ib/II Trial to evaluate the efficacy and the safety of TS-020 in acute COVID-19 viral infection in Patients with Severe Infection with Risk of Progression

Retrieved on: 
Thursday, March 4, 2021

"Preclinical studies demonstrated that TS-020 interferes with SARS-CoV2 replication, triggers antiviral mechanisms of the infected cells and promotes anti-inflammatory immune cell differentiation.

Key Points: 
  • "Preclinical studies demonstrated that TS-020 interferes with SARS-CoV2 replication, triggers antiviral mechanisms of the infected cells and promotes anti-inflammatory immune cell differentiation.
  • COVID-19 patients with acute respiratory distress syndrome due to viral infection are at risk of secondary complications like invasive aspergillosis.
  • TurnSole utilizes its breakthrough proprietary SEMY-TEC platform to develop personalized medicine for major unmet clinical needs within weeks of diagnosis.
  • The Companys asset portfolio contains compounds across a variety of indications and are protected by global composition of matter Intellectual Property.