NEW YORK – Startup Anavasi Diagnostics is ramping up production of its Ascencio point-of-care molecular diagnostic system. The firm completed clinical trials of its COVID-19 test during the Delta and Omicron surges and submitted an Emergency Use Authorization application to the US Food and Drug Administration this week.
Founded in August 2020, Seattle-based Anavasi expects to capitalize on a simple instrument design offering high sensitivity at a low cost, as well as an experienced commercial team.
Although the COVID-19 pandemic is at an ebb in the US currently, rising cases abroad coupled with wastewater increases in certain spots forebode another potential increase in cases here, according to Michael Blaivas, chief medical officer of Anavasi Diagnostics.
The Ascencio COVID test performed well in the clinical trials, Blaivas said, and the firm is now scaling production of detectors and test kits, as well as planning an acceleration of production timed with the anticipated EUA.
The Ascencio is a handheld system that weighs less than one pound and detects a positive result in less than 25 minutes. It uses a fluorescent readout and can multiplex up to four targets. The firm's COVID-19 test detects three sites in the virus's N gene and one control, for example.
A recent technical paper from the team describing a slightly earlier version of the device also notes it can process four samples simultaneously, and that the COVID-19 assay had a limit of detection of 15 SARS-CoV-2 RNA copies per reaction.
Blaivas said that the proprietary chemistries are "easy to adapt" for other targets — the firm has influenza, respiratory syncytial virus, Strep A, and sexually transmitted infections on its list for future menus.
Anavasi was awarded $14.9 million in support last year from the National Institutes of Health RADx program, which also included guidance setting up automated manufacturing lines and support navigating supply chain challenges. According to CEO Nelson Patterson, the system was evaluated by NIH contract labs at Emory University, and it was found to have high sensitivity and specificity, an even lower limit of detection than the firm had initially claimed, and a simple test procedure in usability studies.
Anavasi's core technology incorporates proprietary real-time loop-mediate isothermal amplification (RT-LAMP) methods originally developed to detect HIV variants in the lab of biomedical device engineer Barry Lutz at the University of Washington.
Patterson said in an interview that the proprietary method is protected by four patents, including one for a "highly friendly" polymerase that is easily adaptable to different primers and probes, and one for the algorithm that computes the signal-to-noise detection.
The lab published a proof-of-concept study of the chemistries for HIV variant detection in 2019, showing it compared favorably to sequencing-based approaches. In that incarnation, the system used lyophilized PCR and ligation reagents, primers, and probes designed to detect five HIV variants, and had lateral flow strip detection and software to guide users as well as a proprietary algorithm to capture and interpret test strip results.
Patterson noted that adapting the HIV chemistries to COVID-19 detection was the brainchild of Enos Kline, a staff scientist in the Lutz lab. Another member of the lab, bioengineer Bob Atkinson, then wrote a new algorithm for the testing.
In search of an instrument for their chemistries, the team then reached out to Minh Duong, a cofounder of contract engineering and product development firm Simplexity.
"Mihn was so excited by it, he took a leave of absence from his firm and is one of our cofounders," Patterson said.
The device is manufactured domestically by a partner with a projected sale price of $249 to $349, and each system can perform a minimum of 3,000 tests in its lifetime. The test kits — which include pipettes, lyophilized beads, swabs, and buffers — are priced in the $30 to $40 range.
Gregory Tsongalis, the director of clinical genomics and advanced technology at Dartmouth-Hitchcock Health, noted in an email that a low price is important because POC testing is particularly cost-sensitive, in part because separate instruments are needed for each test site.
The projected pricing of the Anavasi system and tests is "super competitive," Tsongalis said. Although he has not yet himself tested the Ascencio system, he is keen to evaluate it and suggested that there is room for multiple systems in the rapidly expanding POC and at-home testing markets, provided they can deliver on performance.
Anavasi meanwhile expects to have some near-term manufacturing advantages over competitors in this space, should the supply chain issues impacting the diagnostics industry continue, or worsen. This is in part because the Ascencio system only requires a single microprocessor chip and the Anavasi team began sourcing these at the end of 2020, Patterson said.
The firm expects to announce a Series A funding round in the coming weeks.