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Accelerate Diagnostics, Inc. develops rapid in vitro diagnostics for microbiology, with products aimed at sepsis, antibiotic resistance, microbial identification and antimicrobial susceptibility testing. Company updates center on FDA-cleared systems such as the Accelerate Arc system and BC kit, the Accelerate Pheno system and Accelerate PhenoTest BC kit, and regulatory submissions for the Accelerate WAVE system and related positive blood culture test menus.
Recurring disclosures also cover operating results, consumable product sales, Pheno instrument activity, customer contract activity, research and development spending for WAVE, cash resources, financing arrangements and capital-structure matters. Corporate-status updates include the company’s Chapter 11 proceedings and trading-status changes for its common stock.
Accelerate Diagnostics (NASDAQ:AXDX) has received FDA clearance for enhancements to its Accelerate Pheno® system. This upgrade improves antimicrobial susceptibility testing (AST) performance, particularly for treating Pseudomonas aeruginosa infections. The new tests expand the system's AST menu, aiding clinicians in personalized patient care. CEO Jack Phillips emphasized the company's commitment to continual improvement and announced upcoming product releases, including the Accelerate PhenoAST BC GN kit. These advancements aim to reduce testing time significantly, improving patient outcomes.
Accelerate Diagnostics (NASDAQ:AXDX) and BioCheck, Inc. announced FDA Emergency Use Authorization for their individual SARS-CoV-2 IgM and IgG Test Kits. This follows the EUA approval of their fully automated MS-Fast instrument. Accelerate will market and support this serology platform, which processes human serum samples in 30 minutes to detect antibodies indicating COVID-19 infection. The tests target the S1 protein to minimize false positives. The CEO emphasized the importance of flexible testing solutions as serology testing plays a crucial role in combating COVID-19.
Accelerate Diagnostics, Inc. (NASDAQ: AXDX) appointed Dr. Nedal Safwat as Chief Strategy Officer, effective immediately. Dr. Safwat, who previously held key roles at BioMerieux, is anticipated to lead the new product strategy and long-term growth initiatives. CEO Jack Phillips expressed confidence in Dr. Safwat's expertise in microbiology diagnostics. Accelerate Diagnostics focuses on combatting antibiotic resistance and sepsis, with its FDA-cleared Accelerate Pheno® system enhancing clinical outcomes by improving antibiotic therapy decisions.
Accelerate Diagnostics has received Emergency Use Authorization (EUA) from the FDA for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and the MS-Fast instrument. This collaboration enables Accelerate Diagnostics to market a serology-based platform that processes human serum samples in just 30 minutes. The test targets the S1 protein of the coronavirus, minimizing false positives. Leadership emphasizes its importance for COVID-19 demographic surveillance and potential global use. This marks a significant step toward wider adoption of antibody testing.
Accelerate Diagnostics, Inc. (Nasdaq: AXDX) reported its Q2 2020 financial results on August 6, showing a 17% increase in net sales to $2.1 million, compared to $1.8 million in Q2 2019. The company ended the quarter with 201 U.S. live revenue-generating instruments and an additional 213 contracted but not live instruments. However, the net loss stood at $19.2 million, or $0.35 per share. The gross margin decreased to 45% from 50% due to lower overhead absorption. The company launched the PhenoAST Test and plans to launch the PhenoPrep instrument in Q1 2021, bolstering its product portfolio amidst pandemic-related challenges.