EUA

 Celltrion Awarded up to $626 Million From the Department of Defense to Supply COVID-19 Point-of-Care (POC) Rapid Antigen Test Kits

Thursday, September 23, 2021 - 8:00am

Celltrion (KRX:068270) announced today that the Defense Logistics Agency (DLA) under the Department of Defense has awarded Celltrion USA, Inc., a subsidiary company of Celltrion, a procurement contract for its DiaTrustTM COVID-19 Ag Rapid Test.

Key Points: 
  • Celltrion (KRX:068270) announced today that the Defense Logistics Agency (DLA) under the Department of Defense has awarded Celltrion USA, Inc., a subsidiary company of Celltrion, a procurement contract for its DiaTrustTM COVID-19 Ag Rapid Test.
  • Celltrions supply capability for the contract volume is sufficiently supported by the large-scale production facility in Korea.
  • The test kits to be supplied through this contact are point-of-care tests (POCT) which can only be used in the presence of medical professionals.
  • Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs.

Chembio Announces EUA Submission for DPP Respiratory Antigen Panel

Wednesday, September 22, 2021 - 1:00pm

HAUPPAUGE, N.Y., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission of an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for the companys DPP Respiratory Antigen Panel test system.

Key Points: 
  • HAUPPAUGE, N.Y., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced the submission of an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for the companys DPP Respiratory Antigen Panel test system.
  • The DPP Respiratory Antigen Panel test system is designed to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from a single patient sample using a simple nasal swab.
  • The contract also supports preparation of a submission to the FDA in pursuit of 510(k) clearance for the DPP SARS-CoV-2 Antigen test system.
  • Chembios portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA).

Failure of National Pandemic Plan Examined in the Journal of American Physicians and Surgeons

Tuesday, September 21, 2021 - 12:00am

Americans lives have been tragically disrupted and permanently altered by the COVID-19 pandemic.

Key Points: 
  • Americans lives have been tragically disrupted and permanently altered by the COVID-19 pandemic.
  • The U.S. has had a validated National Pandemic Response Plan since 2000, and it was updated in 2017.
  • This virus, SHCO14-CoV, was analogous to the 2003 SARS virus, and was capable of jumping directly from bats to humans.
  • The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943.

Junshi Biosciences Announces Expansion of Emergency Use Authorization for Etesevimab and Bamlanivimab Administered Together to Include Post-Exposure Prophylaxis for COVID-19

Sunday, September 19, 2021 - 12:29pm

The pseudovirus and authentic virus studies demonstrated that the Therapy retains neutralization activity against the Alpha and Delta variants.

Key Points: 
  • The pseudovirus and authentic virus studies demonstrated that the Therapy retains neutralization activity against the Alpha and Delta variants.
  • Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology of the Chinese Academy of Sciences.
  • Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China.
  • Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

BioFluidica Announces Commercialization of its High Throughput LiquidScan™ Automated Liquid Biopsy System for Capturing Rare Biomarkers on a Single Scalable Platform.

Friday, September 17, 2021 - 4:00pm

SAN DIEGO, Sept. 17, 2021 /PRNewswire/ -- BioFluidica, a privately held biotechnology company, announced its plans to commercialize the market's first and only high throughput rare biomarker (circulating tumor cells, exosomes, and cell-free DNA) enrichment solution, the LiquidScan Automated Liquid Biopsy System.

Key Points: 
  • SAN DIEGO, Sept. 17, 2021 /PRNewswire/ -- BioFluidica, a privately held biotechnology company, announced its plans to commercialize the market's first and only high throughput rare biomarker (circulating tumor cells, exosomes, and cell-free DNA) enrichment solution, the LiquidScan Automated Liquid Biopsy System.
  • BioFluidica has succeeded in designing and manufacturing an automation-ready liquid biopsy instrument compatible with Hamilton Robotics Microlab STAR series liquid handlers.
  • "I am very excited that BioFluidica is moving into the commercialization stage of the LiquidScan system for large scale liquid biopsy applications," said Rolf Muller, BioFluidica CEO.
  • The LiquidScan system has been clinically validated to repeatably capture and isolate rare disease biomarkers, such as Circulating Tumor Cells (CTC's).

Dalrada Corporation’s Pala Diagnostics Free COVID-19 Point-of-care Tests Proved Compliance for Nearly 3,000 Outdoor Festival Attendees

Thursday, September 16, 2021 - 8:16pm

Pala Diagnostics, LLC (Pala Diagnostics), a joint venture between Dalrada Health and Vivera Pharmaceuticals, Inc., is a fully operational national laboratory that processes point-of-care, EUA approved, rapid antigen testing, and lab-based PCR testing for COVID-19.

Key Points: 
  • Pala Diagnostics, LLC (Pala Diagnostics), a joint venture between Dalrada Health and Vivera Pharmaceuticals, Inc., is a fully operational national laboratory that processes point-of-care, EUA approved, rapid antigen testing, and lab-based PCR testing for COVID-19.
  • Pala Diagnostics performed both RT-PCR Tests and FDA-authorized Antigen Tests throughout the three-day Boise Pride Festival and Parade .
  • All recipients of Pala Diagnostics HIPAA compliant test results received a text message to retrieve evidence of COVID-19 testing.
  • Established in 1982, the Company has since grown its footprint to include the business divisions: Dalrada Health, Dalrada Precision, and Dalrada Technologies.

Adaptive Biotechnologies to Present New SARS-CoV-2 Data from its Immune Medicine Platform During IDWeek 2021

Thursday, September 16, 2021 - 1:03pm

In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map.

Key Points: 
  • In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map.
  • Adaptive Biotechnologiesis a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease.
  • Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in life sciences research, clinical diagnostics and drug discovery.
  • We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

COVID-19 Scoop: Epoch-Making GoldenBiotech's Oral COVID-19 New Drug Trial Got Green Light from the FDA to Extend Recruiting Severe COVID-19 Patients

Thursday, September 16, 2021 - 11:05am

The total trial subjects will remain the same, 174 patients in total.

Key Points: 
  • The total trial subjects will remain the same, 174 patients in total.
  • The trial recruiting is expedited in full swing covering the USA, Peru and Argentina where the new upheaval pandemic is rampant with highly transmitted SARS-CoV2 variants.
  • "So far, there is no oral drug approved or receives the EUA from the FDA for COVID-19 treatment.
  • It also received the ODD for the treatment of Pancreatic Cancer from European EMA in 2017.

Psomagen, Inc. Expands into Women’s Health Testing with Vaginal Microbiome Research Study - The VProject

Wednesday, September 15, 2021 - 7:34pm

This move began with The VProject , which is recruiting 1,000 women aged 18 and older in the United States to participate in a vaginal microbiome research study.

Key Points: 
  • This move began with The VProject , which is recruiting 1,000 women aged 18 and older in the United States to participate in a vaginal microbiome research study.
  • For their involvement, participants receive a no-cost personalized test of their vaginal microbiome which can be used to understand the state of their vaginal health.
  • This analysis will help us understand how lifestyle factors can impact the vaginal microbiome and womens health overall.
  • Their offerings include gut microbiome testing, genetic trait analysis, vaginal microbiome health, and more.

Therma Bright Successfully Up-lists to the OTCQB Venture Market Under Symbol TBRIF

Tuesday, September 14, 2021 - 12:00pm

Provides Update on FDA-EUA Application Process

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - September 14, 2021) - Therma Bright Inc. (TSXV: THRM) (OTCQB: TBRIF) ("Therma" or the "Company"), developer of its smart-enabled AcuVid COVID-19 Rapid Antigen Saliva Test and other progressive diagnostic and medical device technologies, announced today its successful up-listing from the OTC Pink Sheets to the OTCQB Venture Market (the "OTCQB").
  • Therma Bright will commence trading on the OTCQB with the market open on September 14, 2021, under the symbol "TBRIF".
  • "We're excited to be up-listed to the OTCQB, which is an important milestone for Therma Bright," shared Rob Fia, CEO of Therma Bright.
  • Therma Bright Inc. trades on the TSXV (TSXV: THRM) (OTCQB: TBRIF) (FSE: JNX).