Akonni Biosystems, a Frederick, MD-based molecular diagnostics company that develops, manufactures, and intends to market advanced MDx systems, secured an additional $4M in bridge financing.
Backers included existing investors.
The company, which is preparing for a significant institutional financing round, will use the funds to continue to develop its platform.
Founded in 2003 and led by Charles Daitch, CEO, Akonni is preparing its first FDA submission for a clinical IVD pharmacogenomic test on the TruDx®2000 platform, utilizing its proprietary TruArray® 3D gel-drop microarray technology. In addition, the company plans to list its automated sample prep instrument with the FDA as a Class-I device. It is also accelerating development of its TruDx®3000. Two prototype systems are being deployed to international collaborator sites this year, and pre-clinical studies are planned to begin in 2018 along with additional instrument placements.
As part of its commercialization focus, Akonni plans to use a portion of the new funding to bring its manufacturing facilities and processes under cGMP compliance and achieve ISO13485 certification, and to work with KOLs and collaborators to expand its test menu.
Akonni has 17 US and 24 International issued patents primarily covering sample preparation, microfluidic devices, bio-instrumentation, and integrated systems. Commercial products in its near-term pipeline include rapid sample preparation technologies for nucleic acid extraction and multiplex panel assays for detecting clinically relevant genotypes for pharmacogenomics, human chronic diseases (i.e. cancer and neurodegenerative), and genotypes for infectious diseases such as multidrug-resistant tuberculosis (MDR-TB), extensively drug-resistant tuberculosis (XDR-TB), upper respiratory infections, viral encephalitis, and hospital-acquired infections (MRSA).