Company Product Description Indication Status
Avacta Group plc, of Wetherby, U.K. Affidx SARS-Cov-2 rapid antigen test Lateral flow rapid antigen test Detects SARS-CoV-2 viral antigens Reported initial performance data from ongoing clinical studies in Europe and the U.K.; 30 positive samples were tested with cycle threshold (Ct) values of 26 and below; the lateral flow test identified 29/30 of these correctly as positive, indicating a clinical sensitivity of 96.7% for samples with a Ct value below 26; out of a total of 26 negative samples tested with the lateral flow device, the test correctly identified all 26 as negative, giving a clinical specificity of 100%
Bandgrip Inc., of Chicago Bandgrip Micro-anchor skin closure device Surgical incision closure after orthopedic procedures Study published in the Journal of Wound Care concluded the Bandgrip is more than 5 times faster in closing orthopedic incisions vs. traditional sutures
Biocept Inc., of San Diego Target Selector Molecular assay kit Detects mutations in DNA derived from formalin-fixed paraformaldehyde embedded or blood plasma to give insight into a patient's cancer characteristics and provide tumor biomarker status In a pilot study, Target Selector detected mutations in up to 50% of tissue biopsy specimens, from patients diagnosed with non-small-cell lung cancer, that were deemed quantity not sufficient; results showed that EGFR mutations were detected in 50% (3/6) of patient samples, and KRAS mutations in 17% (1/6) of samples
Lumithera Inc., of Poulsbo, Wash. Valeda Light Delivery system Provides photobiomodulation (PBM) treatment Treats dry age-related macular degeneration (AMD) Reported interim data from the ELECTROLIGHT pilot study in dry AMD patients; 23 eyes from 15 subjects with intermediate dry AMD were treated with the Valeda system (3 times per week for 3 weeks); multi-luminance electroretinogram (ERG) magnitude AUC improved by 14.4% from baseline after completion of the Month 1 treatment (p = 0.001); a positive correlation between multi-luminance ERG and best corrected visual acuity (BCVA) was reported (p < 0.05); positive correlations between multi-luminance ERG and fixed luminance (R = 0.870) and chromatic ERG outcomes (R = 0.676) were also observed; subjects showed approximately 12.6 ± 1.25 letter improvement in BCVA at Month 1 vs. baseline scores
Seegene Inc., of Soul, South Korea Allplex SARS-CoV-2 assay and Allplex SARS-CoV-2/FluA/FluB/RSV assay Molecular PCR tests Detects SARS-CoV-2 and detects/differentiates SARS-CoV-2, influenza and RSV Study showed that Seegene's saliva test for COVID-19 gives just as accurate results as those of the nasopharyngeal specimen; both assays proved the saliva and nasopharyngeal test's percentage agreement for detecting COVID-19 was over 98.8%

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