COVID-19 In Vitro Diagnostic Medical Device - detail
MeduFlow
Manufactured by Medusa19 Life Sciences, United Kingdom
Device identification number
2905
CE Marking
?Yes
HSC common list (RAT)
×No
Physical Support
Lateral flow
Target type
Antigen
Targets
spike protein,
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma), B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-04-20 12:29:26 CET
Comments
The product is the first uk test to achieve home use approval.
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1 AU
Fn
4 AU
Precision
Evaluated
Accuracy
98.6 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.9 %
Clinical Specificity
99.5 %
Type of antigen
Spike protein
Meduflow Updated April
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2905
Updated 20th April
https://covid-19-diagnostics.jrc.ec.europa.eu/devices/detail/2426
Still Selling :
https://bioservuk.com/immunoassay-reagents-and-accessories/
https://bioservuk.com/wp-content/uploads/2021/06/SARS-CoV-2-S1-Affimer-Pair-ELISA-IFU.pdf
https://www.adeptrix.com/store#!/VIROLOGY/c/112388751
Haven't seen these before :
https://www.amerigoscientific.com/affimer-reagents-item-56814.html
15th April
Lateral flow assays (LFAs) widely deployed for on-site diagnosis have predominantly utilized antibodies as recognition molecules. Antibodies with limited thermal stability deteriorate the performance of the LFA over time. Herein, we demonstrate a stable and robust LFA by utilizing thermally stable peptide-based 12–14 kDa affimers as recognition molecules, in lieu of conventional protein-based antibodies to analyze complex samples with a significantly improved shelf life at room temperature. The model system studied here is that of interleukin-8 (IL8) biomarker for validating the efficacy of the proposed approach, using a pair of affimer probes that demonstrates dual functionality of capturing and reporting. Affimers immobilized on the test zone of LFA serve as capture probes for IL8-affimer-MB complexes. Whereas affimers conjugated with the MBs that enable extraction of IL8 from the sample matrix serve as reporters for visual detection. The MB complexes captured at the test zone resulted in brownish test bands that enable concentration-dependent detection of IL8. The assay yielded sensitive visual detection of IL8 at ng/mL levels (~?0.1 ng/mL and 1 ng/mL in buffer and human plasma, respectively), within 20 min, using sample volumes of?~?100 µL. Importantly, the stability of affimer-incorporated LFA improved significantly in contrast to antibody-incorporated LFA over time, even when stored at 4 °C. Therefore, the proposed affimer-based LFA in conjunction with MBs offer stable and reliable detection of biomarkers at clinically relevant concentration ranges in complicated matrices, even without requiring cold storage, hence, offering a promising avenue for on-site diagnosis in resource-limited settings.
https://link.springer.com/article/10.1007/s00216-022-04078-4
Must admit haven't seen these affimers being sold by Merck is it new ?
https://www.merckmillipore.com/GB/en/search/affirmer?search=&TrackingSearchType=SB+-+homepage-search-box+-+OLD&SearchContextPageletUUID=&SearchTerm=affirmer
Affimer Tagged Cubosomes: Targeting of Carcinoembryonic Antigen Expressing Colorectal Cancer Cells Using In Vitro and In Vivo Models
Abstract
Nanomedicines, while having been approved for cancer therapy, present many challenges such as low stability, rapid clearance, and nonspecificity leading to off-target toxicity. Cubosomes are porous lyotropic liquid crystalline nanoparticles that have shown great premise as drug delivery vehicles; however, their behavior in vivo is largely underexplored, hindering clinical translation. Here, we have engineered cubosomes based on the space group Im3m that are loaded with copper acetylacetonate as a model drug, and their surfaces are functionalized for the first time with Affimer proteins via copper-free click chemistry to actively target overexpressed carcinoembryonic antigens on LS174T colorectal cancer cells. Unlike nontargeted cubosomes, Affimer tagged cubosomes showed preferential accumulation in cancer cells compared to normal cells not only in vitro (2D monolayer cell culture and 3D spheroid models) but also in vivo in colorectal cancer mouse xenografts, while exhibiting low nonspecific absorption and toxicity in other vital organs. Cancerous spheroids had maximum cell death compared to noncancerous cells upon targeted delivery. Xenografts subjected to targeted drug-loaded cubosomes showed a 5-7-fold higher drug accumulation in the tumor tissue compared to the liver, kidneys, and other vital organs, a significant decrease in tumor growth, and an increased survival rate compared to the nontargeted group. This work encompasses the first thorough preclinical investigation of Affimer targeted cubosomes as a cancer therapeutic.
Abstract
Nanomedicines, while having been approved for cancer therapy, present many challenges such as low stability, rapid clearance, and nonspecificity leading to off-target toxicity. Cubosomes are porous lyotropic liquid crystalline nanoparticles that have shown great premise as drug delivery vehicles; however, their behavior in vivo is largely underexplored, hindering clinical translation. Here, we have engineered cubosomes based on the space group Im3m that are loaded with copper acetylacetonate as a model drug, and their surfaces are functionalized for the first time with Affimer proteins via copper-free click chemistry to actively target overexpressed carcinoembryonic antigens on LS174T colorectal cancer cells. Unlike nontargeted cubosomes, Affimer tagged cubosomes showed preferential accumulation in cancer cells compared to normal cells not only in vitro (2D monolayer cell culture and 3D spheroid models) but also in vivo in colorectal cancer mouse xenografts, while exhibiting low nonspecific absorption and toxicity in other vital organs. Cancerous spheroids had maximum cell death compared to noncancerous cells upon targeted delivery. Xenografts subjected to targeted drug-loaded cubosomes showed a 5-7-fold higher drug accumulation in the tumor tissue compared to the l
Apicel Therapeutics, a joint venture established in 2020 with British Avacta, is considered a representative achievement of open collaboration. Apicell Therapeutics aims to develop a new cell therapy drug that overcomes the limitations of existing antibody-based therapeutics by fusion of Daewoong Pharmaceutical's DW-MSC and Avacta's antibody-like protein 'Affimer' platform technology.
Currently, there are six new drug pipelines developed by Daewoong Pharmaceutical based on stem cells. Three treatments for acute severe pancreatitis, Alzheimer's disease and stroke are in preclinical stages, and Crohn's disease treatment is in phase 1 clinical trials. DWP710, which is being developed as a treatment for coronavirus, is undergoing clinical trials in Indonesia. Furestem-RA, a rheumatoid arthritis treatment in collaboration with Kangstem Biotech, is undergoing a phase 2 clinical trial.
https://www-thebell-co-kr.translate.goog/free/content/ArticleView.asp?key=202201071111496800107284&svccode=00&page=1&sort=thebell_check_time&_x_tr_sch=http&_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en-US&_x_tr_pto=wapp
Research / Development interesting Stem CeLL
https://www-daewoong-co-kr.translate.goog/kr/rnd/laboratory?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=wapp
dry eye treatment
immune anti-cancer antibody
Stem cell therapy
(immune / inflammatory / nervous system disease)
https://www-daewoong-co-kr.translate.goog/kr/rnd/project?_x_tr_sl=auto&_x_tr_tl=en&_x_tr_hl=en&_x_tr_pto=wapp
Worth another read ..... 'which considerable clinical data has already been generated '.....
https://www.thepharmaletter.com/article/avacta-rockets-as-it-inks-deal-with-bach-biosciences-tufts
The drug development partnership that the company is now initiating with Prof Bachovchin will develop the first example of this new class of drug conjugate based on the combination of Affimer PDL1 inhibitors and an I-DASH small molecule inhibitor, for which considerable clinical data has already been generated by the laboratory at Tufts. Avacta has exclusive rights to commercialize these novel drug conjugates.
Every little helps :
https://www.thisismoney.co.uk/money/markets/article-10700153/SMALL-CAP-MOVERS-Osirium-Engage-XR-Journeo-fly-flag-UK-tech-minnows.html
Apicel Therapeutics, a joint venture between Daewoong Pharmaceutical and British Avacta, announced on the 7th that it had signed a three-party business agreement with China's Biocytogen and Korea Non-clinical Technology Support Center.
The three parties plan to cooperate in the development of animal and disease models for the development of new drugs for immune diseases, supply and demand for animals, and non-clinical trials. In the process of drug development, animal models are used in the non-clinical stage. It studies the relationship between specific genes and diseases and plays a role in testing the safety and efficacy of new drug candidates.
Apicell Therapeutics is conducting proof-of-concept ( PoC ) and toxicity testing of a number of new drug candidates using animal and disease models developed through this collaboration. It plans to verify the efficacy of new drug candidates in various immune disease groups to increase the likelihood of success in new drug development.
Biocytogen is a Chinese company specializing in the development of new antibody drugs. Based on a mouse model that produces human antibodies, we have a gene editing and genetically modified animal development platform. Through this MOU, the company will be in charge of establishing non-clinical animal models related to immune diseases, supplying genetically modified animals, and conducting non-clinical tests.
The Korea Nonclinical Technology Support Center provides the necessary infrastructure (infrastructure) for nonclinical studies and provides overall technology support for efficient nonclinical studies.
Jong-sang Yoo, CEO of Apicell Therapeutics, said, "We will accelerate the development of cell and gene therapy to overcome immune diseases and contribute to improving the quality of life of patients with incurable diseases."
Werey Shen, CEO of Biocytogen, said, "We will contribute to the development of cell and gene therapy products of Apicell Therapeutics by developing various animal models and using non-clinical evaluation systems."
Song Young-jong, CEO of the Korea Nonclinical Technology Support Center, said, "This agreement has great significance in establishing a non-clinical infrastructure for the development of a next-generation cell and gene therapy platform.
Reporter Han Min-soo