Access Biologicals LLC brought online newly released seroconversion panels that measure the level of antibodies against SARS-CoV-2 in blood samples, allowing researchers to determine vaccine efficacy. The panels can detect the point when seroconversion occurs and assess the efficacy of a vaccine against new and existing strains of the novel coronavirus. To build the panels, the Vista, Calif.-based company collected blood samples prior to vaccination and after the first and second doses. The plasma was then tested for IgG antibodies to the S1 and S2 spike proteins of the novel coronavirus using enzyme-linked immunosorbent assays (ELISA) and chemiluminescent assays (CLIA).
LONDON – Memed Diagnostics Ltd. has adapted the point-of-care test it developed to distinguish bacterial from viral infections to enable rapid assessment of the severity of COVID-19 infections in patients being admitted to the hospital. The triaging tool, Memed COVID-19 Severity, has received a CE mark in Europe and is ready for commercial rollout. After securing the CE mark, Memed is now pursuing emergency use authorization for the test from FDA.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbott, Alere, Beckman Coulter, Eyenuk, Gamidor Diagnostics, Pixcell Medical, Quidel, Speedx, Sqi Diagnostics.
LONDON – An attempt to develop an alternative sampling method to replace unpleasant nasopharyngeal swabbing in COVID-19 diagnosis has failed, with researchers at Owlstone Medical Ltd. finding the number of viral particles that can be collected from the breath of hospitalized patients is below the limit of detection. Owlstone is a specialist in collecting and analyzing breath samples to look for volatile organic compounds that are biomarkers of disease, such as lung cancer and asthma.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 908 Devices, Accuray, Biocrucible, CM Life Sciences, Daxor, Concordance Healthcare Solutions, Dermtech, Gemspring Capital Management, Grail, Graphenedx, Illumina, Invivoscribe, Koko, Kkr, Longuevue Capital, Lucid Diagnostics, Medical Microinstruments, Nanalysis, One Moon Scientific, Pacemate, Pavmed, RBC Medical Innovations, Relay Medical, Sema4, Starfish Medical, Transcenta, Twist Bioscience, Upscripthealth, Visualdx, Zavation Medical Products.
New preclinical data from Immunome Inc. gets the company closer to the clinic for studying its three-antibody cocktail’s effect on SARS-CoV-2. “We will file an IND this quarter and get into the clinic,” Immunome’s CEO, Purnanand Sarma, told BioWorld. “Since the number of cases is rising, unfortunately, we think a clinical study could be conducted reasonably quickly.”
Aditxt Technologies Inc. enhanced its immune response test for COVID-19 by adding a high-sensitivity neutralizing antibody quantification. With the expansion, the multidimensional test, Aditxtscore, provides a comprehensive measure of the strength of an individual's immune response to the novel coronavirus.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Foundation Medicine, NG Biotech.
