Seegene, a molecular diagnostics company based in Rockville, Md., and Seoul, Korea, this week launched a multiplex-formatted diagnostic that simultaneously detects 18 of the most common respiratory pathogens to determine whether infections are bacterial or viral.
The company said that its PCR test, which it claims is the first of its kind, could improve how physicians treat respiratory infections by increasing accuracy, decreasing analysis time, and lowering costs.
“The use of this new diagnostic test enables health care personnel to rapidly determine whether a patient's respiratory ailment is caused by a virus or bacteria, and subsequently prescribe the best course of treatment — whether an antibiotic, antiviral, or bed rest,” the company said in a statement.
Seegene’s Seeplex 18-plex respiratory test is designed to detect 11 different respiratory RNA viruses, two DNA viruses, and five pneumonia bacteria from biological samples such as nasopharyngeal aspirate swabs and bronchoalveolar lavage.
The test detects the following viruses: influenza A and B; human respiratory syncytial virus A and B; human parainfluenza virus 1, 2, and 3; human coronavirus 229E/NL63 and OC43/HKU1; as well as human rhinovirus; enterovirus; adenovirus; and bocavirus.
The product also tests for bacteria, including Legionella pneumoniae, Streptococcus pneumoniae, Chlamydophila pneumoniae, Haemophilus influenzae, and Mycoplasma pneumoniae.
According to Seegen the test “breaks the mold of a ‘single pathogen, single test’ testing regime and high false positive/negative results also associated with conventional multiplexing.”
Company officials told Pharmacogenomics Reporter last week that the cost of testing for patients will likely range between $20 to $30.
According to the company, traditional Ag-Ab tests or products that use viral cultures must test for each infection one at a time, making them “laborious, time consuming, and cost-inefficient,” Seegene said. The company added that Seeplex results can be ready in as little as four or five hours, compared with two days to up to a week for traditional methods.
Rapid detection of pathogens causing respiratory infections is critical during the flu season, particularly in the elderly and pediatric populations. “Children or the elderly do not have a strong immune system,” Dae-Hoon Lee, director of R&D molecular diagnostics at Seegeene, told Pharmacogenomics Reporter last week. “If they have a high fever, or other symptoms, then it’s better to determine what is the main cause of the symptom.
“Unfortunately, there is no commercially available test to screen for all of these pathogens. So our approach can cover most of the respiratory viruses or bacteria,” Lee added.
The company already markets a respiratory virus detection system and a respiratory bacterial detection system. Gauging physician demand for a one-step product that will test for all of the major common respiratory pathogens, the company decided to combine the capabilities of the two detection systems into a single test.
When developing Seeplex, the company applied the same dual-priming oligonucleotide technology used for its respiratory virus detection system and automated it for high throughput.
In a Feb. 7 article in Nucleic Acids Research, the company explain that the dual-priming oligonucleotide contains two separate priming regions joined by a polydeoxyinosine linker that “assumes a bubble-like structure which … delineates the boundary between the two parts of the primer.”
This DPO-based system is “a fundamental tool for blocking extension of non-specifically primed templates, and thereby generates consistently high PCR specificity even under less than optimal PCR conditions,” the study authors wrote.
According to the company, this technology eliminates the drawbacks of so-called “single pathogen, single test” systems by “multiplexing without cross-reactivity,” allowing for rapid test results.
Also, in a study conducted by Korea University Hospital using 90 patient samples that compared culture and IFA versus Seegene’s older 12-virus detection system that uses the same DPO technology as the 18-plex test, Seegene’s system was able to detect respiratory infections in nearly twice the number of people.
While by culture and indirect immunofluorescence assay 35 patients were identified as having respiratory infections by a single pathogen, Seegene’s system was able to discern that 61 patients had infections — 52 infected by a single pathogen, eight by two pathogens, and one by three pathogens.
“Seegene's 12-virus detection system also used DPO technology and [was] thus is comparable in accuracy to the 18-plex,” Lee said of that research.
“Unfortunately, there is no commercially available test to screen all of these pathogens. So our approach can cover most of the respiratory viruses or bacteria.”
A Seegene spokesperson told Pharmacogenomics Reporter last week that the Seeplex 18-plex test, which is compatible with common auto sequencers or common capillary electrophoresis machines, will be marketed in the US through clinical reference laboratories.
Seegene supplies the reagents to its clinical lab customers, while reference labs obtain appropriate state licenses and promote the product.
The spokesperson said that the company recently signed a contract with an undisclosed major US reference lab.
While Seegene may be first to market a multi-pathogen multiplexing test, it may eventually have competition in this space. Qiagen in May launched for research use only a single test based on its QIAplex PCR multiplex technology, which would enable doctors to test for up to 12 pathogens at one time [see PGx Reporter 05-30-2007].
QIAplex PCR technology was designed for Luminex detection platforms and is optimized for use with Qiagen’s LiquiChip200 Workstation. The company said the product will require FDA regulatory approval before entering the market.
“Future commercialization of clinical in vitro diagnostic products based on the QIAplex technology requires extensive clinical validation in large scale clinical studies and submission of this testing data to regulatory agencies like the US FDA,” Michael Benecky, Qiagen’s director of regulatory affairs told Pharmacogenomics Reporter this week.
Benecky noted that while the investment costs for the detection platforms are higher than traditional methods, “the market trend clearly goes towards molecular systems with high throughput providing faster diagnosis with improved sensitivity and specificity.”
Additionally, market research indicates that there is a demand for improvements in routine diagnostic methods for respiratory infections, since infections caused by different pathogens have similar symptoms.
“Considering the similar symptoms caused by respiratory pathogens, new multiplex technologies offer great advantages for diagnosis and treatment,’ Benecky said. “The costs for the detection tests pay off … In the long run it is cheaper than testing individual pathogens, making multiplex testing affordable.”