August 29, 2019 | August featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Shield Diagnostics, GNA Biosolutions, Quantabio, and more.
Shield Diagnostics announced that it has been awarded accreditation by the College of American Pathologists (CAP). "Receiving CAP accreditation is an important recognition of our laboratory. It means that our test results are meeting and exceeding industry standards for clinical laboratory testing," said Arthur Baca, Laboratory Director, in a press release. Shield Diagnostics' Chief Executive Officer, Fred Turner, upon learning of the laboratory's accreditation, said in an official statement: "We are proud of our diligent and experienced clinical lab team. Their meticulous work ensures that we maintain the highest standards of excellence in laboratory practices. By providing accurate and rapid test results for the susceptibility of pathogens to less potent antibiotics, we hope to end the abuse of our last defense antibiotics." Press release
GNA Biosolutions announced that it has completed a $13.5M round of financing. The Series C financing round was joined by new investors including GreyBird Ventures, Occident, and Wachstumsfonds Bayern, and existing investors SHS Gesellschaft für Beteiligungsmanagement, Robert Bosch Venture Capital, UVC Partners, Mey Capital Matrix, KfW, and btov Partners. Proceeds from the financing will be used to advance development and secure IVD-CE marking of GNA’s first Point of Care molecular diagnostic platform. "We are very appreciative of the enthusiastic response from our new investors and the continued support of our existing consortium. This Series C funding will help us execute our regulatory strategy and bring PCA to the clinic," said Federico Buersgens, co-founder and Managing Director of GNA Biosolutions, in a press release. GNA plans to launch its POC platform first in the EU, followed by the US. "We believe having this unique combination of European and US investors on board gives GNA an edge – we have assembled a great consortium which will provide us not only with a tremendous depth of experience but also visibility and access to decision makers across our key launch markets." Press release
Quantabio announced the Wisconsin State Laboratory of Hygiene has adopted its technology to improve newborn screening for Spinal Muscular Atrophy (SMA) and Severe Combined Immunodeficiency (SCID). Scientists are using the Quantabio Extracta DBS technology and PerfeCTa Multiplex qPCR ToughMix kit to develop and validate a real‐time PCR assay to simultaneously screen for both disorders. In addition, the Extracta DBS reagent was also used for an optimized digital PCR (dPCR) assay for additional SMN2 copy number assessment following up on positive SMA. The information about SMN2 can help assess the severity of the condition. SMA is one of the most common lethal recessive genetic conditions, with an incidence of one in 11,000 births. Public health laboratories have been searching for methods to identify affected children earlier to provide more effective care. The new multiplex PCR and digital PCR assays developed by the Wisconsin State Laboratory provide a faster, easier and more affordable screening approach. Compared to traditional methods, the Extracta DBS reagent provides more efficient DNA extraction from dried blood spots and the PerfeCTa Multiplex qPCR ToughMix reagents enable more sensitive assays. Press release
Gradientech announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 14/903,032, "Use of Fluidic Device". The patent application covers the proprietary minimum inhibitory concentration (MIC) determination of a bacterial sample within a microfluidic controlled environment that is part of the technology platform of the company’s diagnostic system QuickMIC for ultra-rapid AST in development. Press release
Biological Specialty Company (BSC) announced the introduction of a series of enhancements to the donor experience at its centers in Colmar, Allentown and Reading, PA. BSC specializes in collecting blood, plasma, serum, white cells, red cells, and other biofluids from consented donors. "We greatly value our donors and their contributions of blood products and biospecimens to further medical research," said BioIVT VP of Donor Center Operations Jeff Widdoss, in a press release. "We wanted to show our appreciation in tangible ways, such as by providing upgraded refreshments, improved compensation, additional entertainment options during donations, and a dedicated donor services team." Press release