Akonni Biosystems receives FDA 510(k) clearance of Its TruDiagnosis multiplex diagnostic system

FDA clearance is part of company’s three-part strategy to change the business paradigm for the molecular diagnostic industry

Akonni Biosystems announced that the US Food and Drug Administration (FDA) has provided 510(k) clearance for its TruDiagnosis^® System. With this approval, Akonni is poised to enter the $8B molecular diagnostics market. The TruDiagnosis^® System is a compact point of service molecular diagnostic device which includes the TruDx^® 2000 Imager and the TruArray^® consumable test kit, both unique and patented technologies developed at Akonni. The FDA cleared assay is a non-invasive saliva test that identifies genetic signatures associated with patient metabolization of the drug Coumadin^® which will assist doctors in adjusting a patient’s therapeutic dose to safer and more effective levels. “This is an important first step in our goal to bring personalized medicine to the general population at a cost-effective price point without sacrificing diagnostic accuracy and precision,” said Akonni CEO, Dr. Charles Daitch.

Akonni’s science and technology comprise a breakthrough diagnostic platform which will enable the further development of tests in oncology, cardiology, infectious disease, and pharmacology that are more accurate, reliable and cost-effective than products currently available on the market.  “This clearance was vital to Akonni’s three-step regulatory strategy where step one was to get the instrument, software and consumable test to meet the stringent regulatory requirements for the design and manufacturing of a high-quality FDA-cleared in-vitro diagnostic (IVD) device,” said Dr. Daitch. “Step two is to ‘crank the handle’ on expanding the assay test menu via Akonni’s internal content development program, and to work with partners to build-out their own diagnostic content. Step three is to scale manufacturing to provide even lower unit pricing than available.”

“The FDA clearance enables Akonni to work with a whole new class of partners who have their own internal diagnostic assays (LDT or RUO) which will benefit from a market strategy that includes an FDA-approved instrument,” Dr. Daitch said. “Partners can develop their assays for use on the TruArray^® consumable device. The unique microfluidic design of the TruArray test integrates on-chip PCR with one to hundreds of microsensors in a single chamber resulting in a much faster workflow and a cost-effective consumable for multiplexed genotyping as compared to traditional microarray or sequencing-based technologies.”

“Very few companies have achieved FDA approval of non-contact piezo-electric printed microarrays and we are delighted to have supported Akonni from product development through this key milestone for full commercialization,” says Alastair Malcolm, CEO of Applied Microarrays Akonni’s contract manufacturer. “Akonni’s exciting form factor and the unique flow-cell microarray production process is going to open up a new era in IVD clinical diagnostic testing of complex diseases, the same way immunochromatographic test strips changed the single-analyte, over-the-counter diagnostic landscape.”

“The molecular diagnostic industry has been burned by high-end research technologies being force fitted into the quality-stringent, price-sensitive world of clinical diagnostics,” Dr. Daitch stated. “Companies have had to charge too much for over-engineered, complex test cartridges. It’s a broken business model for the healthcare industry and Akonni’s goal is to fix this. Many companies have had to penetrate and seed the market by giving away or subsidizing their high-cost consumables resulting in an artificially inflated installed base and a protracted path to profitability. Akonni will expand into the market and reach profitability faster as a result of our technology advancements built into the TruDiagnosis^® System.”