The firm was incorporated in May as a privately held subsidiary of PositiveID Corporation to continue the commercialisation of the FireflyDX product line.
FireflyDX-Portable launch is planned for summer of 2018 and FireflyDX-Handheld in 2019.
The systems combine sample lysis, purification, real time PCR analysis and reporting of results.
It takes 30 minutes or less from sample capture to test results as sample preparation occurs within the cartridges and not as a separate process.
An on-site option
Kimothy Smith, chief science officer, said the FireflyDX concept uses well-known RT PCR and TaqMan chemistry with standard input and reaction volumes.
“The purpose is lab grade results at point of care and point of need (POC/PON) or at the place of sample with an answer in 30 minutes or less,” he told us.
“There is a market pull for testing that you can do onsite. Producers want to assure self-compliance. Natural first targets are Salmonella and pathogenic E. coli.
“We will never replace the centralised lab with a particular high throughput but there is a desire to perform tests at a remote location rapidly.
“We adopted an open assay architecture as there are many different assays out there from different regulatory agencies and commercially. We can put an existing assay onto the platform in around two weeks. For custom assays we have partnered with GenArraytion to do that.”
The partnership with GenArraytion will provide access to their cleared assays in the AgBio space.
FireflyDX-Portable has a multiplex-PCR approach (four targets) to generating pathogen detection results and uses single-use, disposable cartridges with pre-programed RFID chips.
The presence/absence device does not give an answer on viability.
Instrument display can be programmed to show red or green for positive or negative results or give details such as amplification curves and Ct values for more sophisticated users.
Use of microfluidics
Most current Polymerase Chain Reaction (PCR) systems for pathogen detection typically require a professionally trained operator working in a lab setting and/or are heavy, bulky and tied to a personal computer.
“As a benchmark for sample preparation efficiency and PCR limit of detection (LOD) we use a Qiagen kit for sample preparation and we achieve equal or better returns of nucleic acid and with the ABI 7500 we achieve equivalent results in LOD,” said Smith.
“We can analyse anything provided it is in a liquid matrix. With a swab or environmental we have to make sure it is in buffer before going on.
“There is no universal sample preparation protocol, milk’s high fat content is problematic and plant materials can be problematic.”
PositiveID specializes in development of microfluidic systems for automated preparation of biological assays and has an office in Delray Beach, Florida and a lab in Pleasanton, California.
“Recent market developments have inspired us to expand our development efforts onto a new path, one that will require little if any regulatory oversight initially, yet, we believe, will allow us to solve the challenges faced by several markets,” said Lyle Probst, president, CEO and founder of ExcitePCR.