IntelligentMDx announced that it’s developed an assay solution for influenza that can distinguish seasonal strains from the H1N1 variant, better known as the Swine Flu.
The company said the assay will be available during the autumn flu season and was designed to comply with Food & Drug Administration and other regulatory guidelines.
IntelligentMDx spokeswoman Elizabeth Holland wrote in an email that the test can also detect a patient’s potential resistance or susceptibility to anti-viral medications.
The company is pursuing FDA approval and a CE Mark from the European Union, Holland added, writing that the company is ahead of schedule for getting the test to market.
“We realize the importance of the assay … in light of the heightened concern with the coming flu season and are doing everything within our capacity to pull the timeline in even further,” she wrote.
The company is working on so-called “intelligent” diagnostic kits for rapid tests of infectious diseases. The devices make copies of genetic material from a small number of cells or fluid samples, simultaneously testing them for chemical markers specific to different diseases.
The devices also rely on mathematical algorithms to predict test failure and to simulate outside factors such as genetic mutations or contamination that could affect results. CEO Alice Jacobs and two other Boston-area researchers received a U.S. patent in June 2005 for a prototype of the devices now being readied for production.
The company recently completed renovations at its Cambridge facility, roughly doubling its size to about 18,000 square feet and adding new Biosafety Level 2 (BL2) laboratory space. BL2 labs allow for work on infectious agents, with numerous safeguards built into their designs to keep disease-carrying materials from escaping the workspace as well as preventing outside contamination.