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Roche provides molecular testing solutions to identify and differentiate SARS-CoV-2 Omicron variants of concern
Roche and its subsidiary,TibMolbiol, confirm that it has tests for research use that identify the SARS-CoV-2subvariants of concern, Omicron: BA.1, BA.1.1, BA.2, BA.2.2, BA.3 and DeltaThe World Health Organization (WHO) has recently reported that the BA.2subvariant is steadily increasing in prevalence, specifically in Denmark Use of these tests assess the spread of circulating variants and can help monitor the potential impact of therapeutics, vaccines and public health interventionsAll Roche SARS-Cov-2 tests correctly identify the virus including these newsubvariantsBasel, 16 March 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)...
Source: Roche Investor Update - March 16, 2022 Category: Pharmaceuticals Source Type: news

Roche has rapidly developed additional testing options to differentiate mutations in the Omicron SARS-CoV-2 variant
Basel, 3 December 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and TIB Molbiol, a newly acquired subsidiary within the Roche Diagnostics division, have added three additional Research Use Only (RUO) test kits for the detection of mutations present in the novel B.1.1.529 Omicron SARS-CoV-2 variant: VirSNip SARS Spike ins214EPE (RUO), VirSNiP SARS-CoV-2 Spike S371L S373P (RUO), VirSNip SARS Spike E484A (RUO). The World Health Organization (WHO) has classified the recently emerged SARS-CoV-2 variant, Omicron (B.1.1.529), as a COVID-19 variant of concern (VOC).The VirSNiP variant kits allow differentiation between unique mutation...
Source: Roche Investor Update - December 3, 2021 Category: Pharmaceuticals Source Type: news

Updates and Challenges in Fecal Microbiota Transplantation for Clostridioides difficile Infection in Children
Fecal microbiota transplantation (FMT) is currently the most effective but loosely regulated therapy, for recurrent Clostridioides difficile infection (rCDI) in pediatrics. Over the last 2 years, there have been mounting challenges in the ability to provide FMT to pediatric patients. Firstly, an Food and Drug Administration (FDA) safety alert in 2019 reported transmission of a multidrug resistant organism from FMT donor to recipient resulting in the death of 1 patient. Secondly, the coronavirus disease 2019 (COVID-19) pandemic induced further safety and regulatory challenges. Biotherapeutics are promising and more readily ...
Source: Journal of Pediatric Gastroenterology and Nutrition - September 29, 2021 Category: Gastroenterology Tags: Topic of the Month Source Type: research

Beginning to understand clinical events and immune responses of hematopoietic cell transplant recipients receiving SARS-CoV-2 vaccination
The clinical strategy of vaccination for severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) is a preventative therapy authorized by the Food and Drug Administration (FDA) under Emergency Use Authorization (EUA), and is the most important development in the fight against the SARS-CoV-2 pandemic. Patients with hematological cancers are at increased risk of severe coronavirus disease and death [1]. The development of two mRNA vaccines [2] and an adenovirus vaccine [3] represents SARS-CoV-2 technology that has been studied in healthy adults.
Source: Biology of Blood and Marrow Transplantation - August 26, 2021 Category: Hematology Authors: Jo-Anne H. Young Tags: The Bottom Line Source Type: research

F.D.A. Authorizes Third Covid Shot for Immunocompromised
The authorization applies to people who received solid organ transplants and others with similarly compromised immune systems.
Source: NYT Health - August 13, 2021 Category: Consumer Health News Authors: Noah Weiland and Sharon LaFraniere Tags: Vaccination and Immunization Coronavirus (2019-nCoV) Food and Drug Administration Moderna Inc Pfizer Inc Source Type: news

FDA Authorizes Booster Shot of COVID-19 Vaccine for People With Weakened Immune Systems
WASHINGTON (AP) — U.S. regulators say transplant recipients and others with severely weakened immune systems can get an extra dose of the Pfizer or Moderna COVID-19 vaccines to better protect them as the delta variant continues to surge. The late-night announcement Thursday by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders. Several other countries, including France and Israel, have similar recommendations. It’s harder for vaccines to rev up an immune system suppressed by certain medications and ...
Source: TIME: Health - August 13, 2021 Category: Consumer Health News Authors: AP / Lauran Neergaard and Matthew Perrone Tags: Uncategorized COVID-19 Source Type: news

F.D.A. Aiming to Speed Vaccine Booster Shot for Immunocompromised Patients
Worried about a vulnerable population as the Delta variant surges, administration officials are taking a new tack.
Source: NYT Health - August 7, 2021 Category: Consumer Health News Authors: Apoorva Mandavilli and Sharon LaFraniere Tags: your-feed-science Immune System Transplants Vaccination and Immunization Coronavirus (2019-nCoV) Food and Drug Administration Disease Rates Centers for Disease Control and Prevention Fauci, Anthony S Source Type: news

Important Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the 2019 Novel Coronavirus Outbreak
Source: U.S. Food and Drug Administration (FDA). Published: 2/14/2020. While respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of human cells, tissues, or cellular or tissue-based products (HCT/Ps), the potential for transmission of COVID-19 (2019 novel coronavirus) by HCT/Ps is unknown at this time. According to this information from the Food and Drug Administration (FDA), there have been no reported cases of transmission of COVID-19 via these products. The FDA will continue to monitor the situation and will issue updates as information becomes available. (Text)
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - February 14, 2020 Category: International Medicine & Public Health Source Type: news