NEW YORK (GenomeWeb) – Adding to an expanding menu of molecular diagnostic assays on its Illumigene platform, Meridian Biosciences is developing a test for the malaria-causing plasmodium parasite.
The assay uses the firm's loop-mediated isothermal amplification-based (LAMP) platform to detect all five species of plasmodium directly from patient blood samples.
Meridian presented preliminary data on the test at the recent annual meetings of the American Society of Tropical Medicine & Hygiene and the Association of Molecular Pathology. The test, which has a reported analytical sensitivity of two parasites per microliter, has been developed through interactions with the US Centers for Disease Control and Prevention, and the agency reportedly helped Meridian set up recently-concluded clinical trials in Senegal. The trial data will now be used to support CE-marking of the assay.
Including the malaria test, the Cincinnati, Ohio-based firm will soon have a worldwide menu of nine assays, Meridian Senior Product Manager Luke Maitland told GenomeWeb.
Specifically, the firm launched the Illumigene C. difficile assay in 2010, and it has added about one test each year since then. The menu now includes Group B Strep, Group A Strep, mycoplasma pneumoniae, bordetella pertussis, and HSV 1 and 2. Those tests are CE-marked and have also been approved by the US Food and Drug Administration. Meridian also markets a CE-marked chlamydia and gonorrhea assay on Illumigene, and it is developing a campylobacter test in addition to the malaria assay.
"We've had a great deal of success with these commercial assays over the past five years, and have about 1,465 people using this platform right now," Maitland said.
Unlike PCR-based tests, isothermal nucleic acid amplification tests only require samples to be heated to a single temperature. Meridian's tests run on the firm's Illumipro-10 instrument for the reaction and detection.
Slava Elagin, the firms' executive vice president of research and development, told GenomeWeb that the malaria test required invention of a new sample prep method for Illumigene. There was very little inhibition reported in the clinical trials due to the proprietary chemistry for whole blood and the fact that LAMP is less sensitive to inhibitors than typical PCR tests, he added.
The total hands on time to set up the malaria test is about one minute. "It goes through one simple sample manipulation and then goes directly to our incubator and reader — the total time from start to finish is about 42 minutes. It's very quick," Elagin said.
Maitland also noted that the test demonstrates high sensitivity and specificity. "The kit has every component needed to run the assay, and we always try to ensure that the storage conditions are ambient temperatures with a shelf life of 18 months," he said.
The firm is now planning to launch the malaria test in January or February of 2016.
Meridian's test is not the only molecular malaria test available outside of the US, however. In fact, there are a number of lab-developed tests to detect plasmodium, including one using high-resolution melt and nested PCR developed by a lab in Kenya, an isothermal lateral flow test developed in Germany, and a test to differentiate malaria from dengue and leptospirosis being developed at Stanford. There are also a number of rapid immunoassays and microscopy techniques for plasmodium, though these are often either not very sensitive or require more complex workflows.
The challenge with these LDTs, Maitland said, "has been reproducibility, reagent stability, and extraction methods needed" — challenges Meridian's test addresses, according to the company. Indeed, Mike Shaughnessy, Meridian's executive vice president of global diagnostics, said the Illumigene test has "a sensitivity benefit that will allow for identification sooner and aid in eradication."
Meridian may find a more direct competitor in Eiken Chemical of Japan. Eiken's CE-marked molecular plasmodium detection test also runs on a LAMP platform — indeed, Meridian originally licensed the LAMP chemistry from Eiken in 2006.
But Meridian has enhanced the LAMP chemistry since then to optimize it for customer needs, making it easier to use and more accurate for the flagship Illumigene platform, Shaughnessy said. "Meridian is the only company who has an FDA cleared LAMP-based menu [and] currently we have seven assays on the Illumigene platform in the US," he noted.
And while the firm does have a close relationship with Eiken, the Illumigene malaria test was solely developed by Meridian. "We believe that our test has enhanced accuracy and features a simplified workflow," Shaughnessy added.
The Eiken test, which is highlighted on the Foundation for Innovative New Diagnostics (FIND) website, was CE-marked in 2012, and vetted in studies in the UK and Uganda in 2014.
FIND also partnered with Eiken and UK-based Lumora in 2013 to develop a malaria assay using that firm's bioluminescent assay in real-time (BART) technology. Lumora was recently acquired by ERBA Diagnostics Mannheim and the firm plans to further commercialize BART, although the specific fate of the malaria test is unclear. So for now, Meridian's competition in this space may be limited.
Shaughnessy said Meridian will launch its test in Europe first and will look to have "a distribution network that's going to address the available market."
Currently, the firm reaches hospital labs in small to large bed-size hospitals, as well as national and regional reference labs. "All of the assays apart from mycoplasma pneumoniae are moderately complex, [so] we also have physician office labs using a lot of the products as well," Maitland noted.
"We have distributor relationships that allow us to cover probably every call point, all supported by a direct sales force," Shaughnessy said. The firm's sales operation works through non-exclusive distributors, such as Cardinal or Fisher for hospital labs, or Henry Schein in the physician office labs.
All of this recent activity has also seemingly contributed positively to Meridian's bottom line. The company's fiscal year ended in October, and the firm reported modest growth that was notable relative to some other players in the MDx industry.
"We launched [a] Strep pneumo immunological test [and the] CT/NG on the Illumigene platform in Europe, and HSV in both Europe and the US, so it was a good year for new products for Meridian," said Shaughnessy, adding that the firm has seen "very good uptake" so far with the CT/NG test.
"HSV is looking good for us here in the US because it is a big send-out item for hospitals, so they can bring that testing in house," he said. "It also plays into our effort to address physician's office labs in OB/Gyn, where we can be doing HSV testing and maybe GBS, or in the pediatric arena where we have Group A Strep, pertussis, and HSV."