In recent years, Americans have been warned each new flu season, beginning in the fall, that this year’s strain of influenza might trigger a pandemic.
But there’s a problem here — so many types of flu, so many lung diseases, so many symptoms, so many tests for all of these. What are we dealing with here — a bacteria, needing an antibiotic; a virus, needing an antiviral; or something simply requiring bed rest?
How to know?
Seegene (Rockville, Maryland), currently in its fourth year of having a U.S. presence — its primary headquarters being in Seoul, South Korea — moved into the molecular diagnostics business last year. Yesterday, the company reported the introduction of a multiplex-formatted diagnostic test for detecting 18 different pathogens, including 11 different respiratory RNA viruses, 2 DNA viruses and five pneumonia bacteria from samples including nasopharygeal aspirates, nasopharygeal swabs and bronchoalveolar lavage.
The test is based on what the company calls sleeplex technology that it says works in combination with automatic detection systems such as capillary electrophoresis and delivers “a benchmark in testing accuracy, efficiency and cost-effectiveness.”
The diagnostic, called the SeeplexR 18-plex Respiratory Test, is being pitched by the company as enabling healthcare personnel “to test for 18 different pathogens” at the same cost point as testing for a single pathogen.
The 18 pathogens the test detects are: influenza A virus; influenza B virus; human respiratory syncytial virus A; human respiratory synctial virus B; human parainfluenzae viruses 1, 2 and 3; human coronavirus 229E/NL63; human coronavirus OC43/HKU1; human rhinovirus; human enterovirus; human adenovirus; human bocavirus; Legionella pneumoniae; Streptococcus pneumoniae; Chlamydophila pneumoniae; Haemophilus influenzae; Mycoplasma pneumoniae.
“Our strategy is at first we are trying to provide our [test] as an ASR [analyte specific reagent]” to the reference laboratories in the U.S., Dae-Hoon Lee, principal investigator and director of R&D for Seegene, told Medical Device Daily. “They can use our primer system to develop their own evaluation data. After that, we will get [a great deal of] clinical data, and we can provide the documents for 510(k) to the FDA.”
In a statement, Jong-Yoon Chung, Seegene founder and CEO, said, “Our new 18-plex Respiratory Test is what the clinical healthcare industry has been asking for — the ability to routinely test for a wide spectrum of respiratory pathogens in a single test, at the price of a single pathogen test.”
The predecessor to this most recent test, in terms of having 18 pathogens tested at once, is the company’s 18-plex test for Human Papillomaviruses (HPV) introduced last month.
The company in 2006 introduced a respiratory test that detects 12 viruses. So this new test adds one virus and five bacteria to its detection capabilities, and does it using only one tube of sample.
By being able to use just one tube, the test “gives a lot of economic advantages,” said Jessica Joung, general manager, public relations and business development at Seegene. It works with samples including nasopharyngeal aspirates, nasopharyngeal swabs and bronchoalveolar lavage.
Joung said that the test has been in development for six months and has proven in Asian markets to be “robust, reliable and reproducible.”
By providing the exact nature of a patient’s problem, i.e., the specific type of virus or bacterial infection, Joung said that this will enable physicians to treat patients with a form of “personalized medicine” by knowing the correct drug therapy to choose as soon as possible.
Current tests for respiratory viruses and bacteria, such as viral culture and Ag-Ab test are “laborious, time consuming and cost inefficient,” the company says.
A study on Seegene’s dual priming oligonucleotide system technology was published Feb. 7, 2007, in Nucleic Acids Research.
In the study, the authors, including Jong-Yoon Chun, suggest that a “fundamental solution for eliminating non-specific priming still remains a challenge and limits the versatility of PCR in nucleic acid-based tests.”
The company says that the Seeplex system uses Dual Priming Oligo (DPO) and Annealing Control Primer (ACP to create its multi-pathogen tests.
In the abstract the researchers write that the “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.”
Joung said that the company has had a “great response” to its molecular diagnostics offerings in Korea and the Asian markets.
“We think it’s time to activate the U.S. business in molecular diagnostics,” she said. Seegene is in the process of forming a U.S. corporation. The company currently has four employees in the U.S. but is in the process of recruiting a direct sales force for its products.
Next month, Lee said that the company plans to introduce yet another 18-plex test focusing on sepsis, including both Gram-positive and Gram-negative types of this blood infection.