Immunetics, an immunological and molecular diagnostic testing firm, has begun working under a new Phase II SBIR grant awarded this January to clinically validate a PCR amplification- and array hybridization-based test for about 30 fungal pathogens.
The funding, a total of $3 million over three years from the National Institute of Allergy and Infectious Diseases, will support the final steps of development and optimization, as well as both retrospective and clinical validation of the assay with two academic medical centers, Andrew Levin, Immunetics' president and CEO, told GenomeWeb this week.
Using the data collected in its clinical validation — which should be complete by the end of the three-year grant period — the company then plans to submit the assay for approval by the US Food and Drug Administration.
"This would be the first product of this type that the FDA would approve," Levin said.
According to Levin, as the population of patients susceptible to severe fungal infection — mainly those who are immunosuppressed or immunocompromised due to transplantation, cancer treatment, or diseases like HIV — has grown, so has a recognition that the field requires much better tools for diagnosis than traditional culture methods.
"Fungal pathogens have been sort of a backwater for many years … but it's becoming more recognized and has emerged as a field that really needs and deserves a lot more medical attention," he said.
Immunetics is not the only company or group heeding this call. For example, a team from the University of Texas Health Science Center in San Antonio last year published a new method for extraction and amplification of fungal DNA for sequence-based identification of fungi.
Commercial products aimed at diagnosing infectious pathogens in cases of sepsis also frequently include a handful of fungal species, Levin said. For example, T2 Biosystems has seen success with its sepsis assay focused specifically on Candida.
Meanwhile, Abbott is continuing to develop its Iridica platform (previously Plex-ID), which includes a panel to differentiate 200 families of fungi. The Iridica system, however, requires a large, relatively expensive instrument, and is available for research use only in the US.
According to Levin, there has yet to be a technology commercialized for clinical use in the US that offers rapid identification of a broad range of fungal species without an expensive instrumentation requirement, and Immunetics hopes its assay will fill this unmet need.
"The fact that T2 has made such an impact suggests that there really is a need here. We wanted to look beyond Candida, which is fairly common, to develop a panel that would allow detection of a broad range of these esoteric pathogens in one fell swoop," he said.
According to the Immunetics' grant abstract for its new second phase of funding, the company's fungal infection test relies on PCR amplification followed by hybridization on a microarray using species-specific probes.
"The uniqueness of the assay is really the combination of our primer sequences, which are aimed at amplifying a broad range of fungi, and these species-specific probes that allow us to identify a range of different species very specifically," Levin explained.
"The array is built on the use of these species-specific probe sequences, which allow us to do a single amplification and then identify what is amplified among these targets," he said.
According to Levin, Immunetics is still working on final development steps for the assay.
"We have some time ahead of us to finish developing the product to the point where it can be put in someone else's lab," he said. "We are still working on the instrument format, but we are aiming at something that will be very available and accessible to users — not requiring something too sophisticated or exotic."
According to the company, the assay is expected to have an approximately five-hour turnaround time.
Once the test is solidified enough to be used in outside labs, the company will begin its clinical validation, working with partners in two large clinical centers that see significant numbers of fungal infection patients.
"When we get to the right point they will help us with validation of the assay in real time – on actual patient populations," Levin said. "The aim is to take the prototype assay we developed in phase I and fully develop it as a commercial product."
This validation study will likely begin in the second and third year of the company's Phase II funding, and will finish by the end of the three-year grant, enabling Immunetics to then submit the assay to the FDA.
The funding, a total of $3 million over three years from the National Institute of Allergy and Infectious Diseases, will support the final steps of development and optimization, as well as both retrospective and clinical validation of the assay with two academic medical centers, Andrew Levin, Immunetics' president and CEO, told GenomeWeb this week.
Using the data collected in its clinical validation — which should be complete by the end of the three-year grant period — the company then plans to submit the assay for approval by the US Food and Drug Administration.
"This would be the first product of this type that the FDA would approve," Levin said.
According to Levin, as the population of patients susceptible to severe fungal infection — mainly those who are immunosuppressed or immunocompromised due to transplantation, cancer treatment, or diseases like HIV — has grown, so has a recognition that the field requires much better tools for diagnosis than traditional culture methods.
"Fungal pathogens have been sort of a backwater for many years … but it's becoming more recognized and has emerged as a field that really needs and deserves a lot more medical attention," he said.
Immunetics is not the only company or group heeding this call. For example, a team from the University of Texas Health Science Center in San Antonio last year published a new method for extraction and amplification of fungal DNA for sequence-based identification of fungi.
Commercial products aimed at diagnosing infectious pathogens in cases of sepsis also frequently include a handful of fungal species, Levin said. For example, T2 Biosystems has seen success with its sepsis assay focused specifically on Candida.
Meanwhile, Abbott is continuing to develop its Iridica platform (previously Plex-ID), which includes a panel to differentiate 200 families of fungi. The Iridica system, however, requires a large, relatively expensive instrument, and is available for research use only in the US.
According to Levin, there has yet to be a technology commercialized for clinical use in the US that offers rapid identification of a broad range of fungal species without an expensive instrumentation requirement, and Immunetics hopes its assay will fill this unmet need.
"The fact that T2 has made such an impact suggests that there really is a need here. We wanted to look beyond Candida, which is fairly common, to develop a panel that would allow detection of a broad range of these esoteric pathogens in one fell swoop," he said.
According to the Immunetics' grant abstract for its new second phase of funding, the company's fungal infection test relies on PCR amplification followed by hybridization on a microarray using species-specific probes.
"The uniqueness of the assay is really the combination of our primer sequences, which are aimed at amplifying a broad range of fungi, and these species-specific probes that allow us to identify a range of different species very specifically," Levin explained.
"The array is built on the use of these species-specific probe sequences, which allow us to do a single amplification and then identify what is amplified among these targets," he said.
According to Levin, Immunetics is still working on final development steps for the assay.
"We have some time ahead of us to finish developing the product to the point where it can be put in someone else's lab," he said. "We are still working on the instrument format, but we are aiming at something that will be very available and accessible to users — not requiring something too sophisticated or exotic."
According to the company, the assay is expected to have an approximately five-hour turnaround time.
Once the test is solidified enough to be used in outside labs, the company will begin its clinical validation, working with partners in two large clinical centers that see significant numbers of fungal infection patients.
"When we get to the right point they will help us with validation of the assay in real time – on actual patient populations," Levin said. "The aim is to take the prototype assay we developed in phase I and fully develop it as a commercial product."
This validation study will likely begin in the second and third year of the company's Phase II funding, and will finish by the end of the three-year grant, enabling Immunetics to then submit the assay to the FDA.