Everyone knows that laboratories are under pressure to achieve more with less—more testing and more cost savings with less staff and less money. But under the right circumstances, labs may discover that less is more.
In this case, the less intimidating that a laboratory finds molecular testing, the more likely it is to implement a molecular testing platform, and the more likely it is to reap the benefits. “Technological advances have significantly lowered the barriers for clinical labs to adopt molecular testing,” says Wade Stevenson, diagnostics marketing manager for Idaho Technology. “Anything that makes molecular testing easier and faster is a hot topic right now.”
Representatives of the other companies in this month’s product guide, which focuses on automated molecular testing platforms, agree. Shane McCann, Roche Diagnostics virology group marketing manager, says minimum hands-on time and maximum walk-away time are what lab managers say their operators need. “So, in addition to automated systems that are controlled using software, we’ve addressed those needs with things like ready-to-use reagents that don’t require mixing, labeling, pouring, and other labor-intensive activities; bidirectional LIS functionality; and very low instrument maintenance requirements.”
By way of example, his colleague Andy Plank, group marketing manager for women’s health, points to Roche’s Cobas 4800 system. “It automates nucleic acid purification, PCR setup, and real-time PCR amplification and detection, which translates into less hands-on time, true walk-away performance, and as a result, maximum efficiency for the lab,” he says. “For example, it takes less than 30 minutes of hands-on time to begin a run of 96 samples.”
Newly available on the Cobas 4800 is the Cobas HPV test, which individually identifies genotypes 16 and 18 while simultaneously detecting 12 other high-risk genotypes. “We’ve undertaken the largest cervical cancer registrational screening study in the U.S.—the ATHENA trial, with over 47,000 women—and it shows that the test provides important predictive information that Pap tests alone do not,” Plank says.
In the future, he adds, Roche will expand the menu for the Cobas 4800 to “allow small and medium-volume labs to maximize their investment in the platform.” One test now awaiting 510(k) clearance: an IVD nucleic acid amplification test for the qualitative detection of Chlamydia and gonorrhea. The test uses amplification of target DNA via PCR and nucleic acid hybridization to detect CT and NG DNA in endocervical or vaginal swab specimens, or in male or female urine.
At AutoGenomics, recent developments include the enhancement of throughput with the Infiniti Plus analyzer, which senior vice president Ramanath Vairavan calls “twice as fast, with double the sample handling capacity of the Infiniti.” It’s designed to meet the needs of laboratories processing 100 tests per day, he says, adding that at the same time, the company is developing a higher-throughput automated system—the Infiniti HTS—which will be capable of running more than 500 tests daily. “All the Infiniti analyzers will be able to process the same BioFilmChip microarrays with almost 50 applications,” such as the only 510(k)-cleared 2C19 test on the market and the newly added novel test for familial Mediterranean fever, he says.
Gen-Probe has introduced its new Panther molecular diagnostic instrument into European and other non-U.S. markets. The random-access system automatically downloads test requests via a bidirectional host interface when samples are loaded. Operators have continuous access to reagents and samples, and radio frequency identification tags on all universal fluids allow for replenishment of reagents and automated capture of lot numbers and dating.
“What sets this instrument apart from others in the molecular space is that it has been designed with features and functionality that are typically associated with a chemistry/immunochemistry platform,” says Chris Parkhouse, senior marketing director for infectious diseases and systems. “From a chemistry perspective, it has been designed to run both end-point and real-time TMA assays. Real-time studies will begin on the platform in 2012.” Meanwhile, Gen-Probe hopes this year to gain FDA approval for its Aptima HPV and Progensa PCA3 assays.
Idaho Technology’s latest: the FilmArray system, which “automates all the processes required for molecular testing” and “requires only two minutes of hands-on time,” says Stevenson. In April, the company received FDA clearance for its FilmArray respiratory panel, a multiplexed nucleic acid test designed to simultaneously detect 15 respiratory viruses in an hour. “We believe this is the most user-friendly multiplex PCR test for respiratory viruses available today,” he says. Among the other FilmArray applications Idaho is developing are gastrointestinal, blood culture identification, and STI panels.
Nanosphere, meanwhile, is nearing completion of clinical studies on its multiplexed gram-positive, gram-negative, and fungal blood culture assays for the company’s Verigene benchtop molecular diagnostics workstation. These assays “are capable of detecting over 95 percent of all microbial targets found in blood cultures,” says vice president Mike McGarrity. “These cartridge-based sample-to-result assays also provide antimicrobial resistance information in approximately two hours directly from a positive blood culture.”
“A great success”: That’s how Qiagen business director Line Martinsen describes the February launch of the company’s QIAsymphony RGQ molecular testing system in the United States. “In Europe, we have the broadest CE-IVD assay portfolio on the market on the RGQ, and our strategy is to take this assay portfolio global,” she says, calling the system “ideal for labs that run multiple parameters, receive samples at different times of day, and don’t want to wait to fill a batch.” The system consists of the company’s QIAsymphony SP for sample preparation, the QIAsymphony AS for assay setup, and ready-to-use assays on the Rotor-Gene Q real-time PCR cycler. “Several of our U.S. customers have installed the QIAsymphony RGQ to integrate into their Lean lab concept, as it enables the lab to consolidate all its assays onto one platform and features continuous loading,” Martinsen says.
This fall, Qiagen intends to launch QIAsymphony RGQ Certal kits for automated isolation and detection of residual DNA for research use. “Although the product is not yet officially launched, we already have sold several kits and QIAsymphony instruments, and are in discussion with several companies, which really shows the demand in the market,” Martinsen says. In addition, Qiagen submitted to the FDA the final module of a premarket approval for the Therascreen KRAS RGQ PCR kit, which she says will be the first KRAS in vitro diagnostic of its kind in the U.S.
Recent world events have implications for a product from Life Technologies, says Kim Caple, head of molecular medicine. “The recent E. coli outbreak in Europe is a good example of how next-generation sequencing, using Life Technologies’ Ion Torrent platform, led to creation of targeted molecular tests for a modified bacterial strain,” she says. “While these tests are for food testing, similar rapid translation of research results to clinical testing can be expected.”
In the meantime, her company has begun offering a FFPE KRAS control that she calls “our most innovative recent product introduction” and “the first full process control for FFPE, which will assist laboratories in assessing the accuracy of KRAS results.” Another recent launch: a group of standards and controls for HSV 1 and 2 and VZV testing, “which complement our existing transplant portfolio,” she says. In addition, Life Technologies plans to submit its Applied Biosystems 3500 Dx genetic analyzer to the FDA shortly, along with an HLA assay for transplant tissue typing. “The 3500 is a capillary electrophoresis sequencer specifically designed for the clinical lab,” she says.
Abbott reached a milestone in June with the one-thousandth global placement of its m2000 RealTime automated molecular diagnostics system. The system, which uses real-time PCR to detect and monitor infectious diseases, features proprietary MaxRatio data analysis to perform multiple validity checks on each patient result. Having added the HCV viral load assay to the system, Abbott says it is now the only U.S. molecular diagnostics supplier to offer viral load assays for HIV, HBV, and HCV and a combination test for Chlamydia and gonorrhea on one molecular platform.
The growing interest by clinical laboratories to perform multiplex testing has driven customer demand for GenMark Diagnostics’ eSensor XT-8 platform, says Jeff Hawkins, senior vice president of marketing and business development. In addition to FDA-cleared tests for cystic fibrosis genotyping, warfarin sensitivity, and thrombophilia risk, the company has several multiplex molecular diagnostic tests in various stages of development. Among them are the eSensor Respiratory Viral Panel for the simultaneous detection and identification of multiple respiratory viruses; the eSensor 2C19 test for the multiplex detection and genotyping of the *2 through *10, *13, and *17 alleles of the cytochrome P450 (CYP450) 2C19 gene locus; and the eSensor HCV Genotyping test for typing/subtyping of HCV 1a, 1b, 2a/c, 2b, 3, 4, 5, and 6a/b.
Finally, Siemens Healthcare Diagnostics has introduced Trugene HIV-1 GuideLines Rules 16.0, the latest edition of the company’s interpretation algorithm for HIV-1 drug resistance testing.
CAP TODAY’s product guide to automated molecular testing platforms includes products from the companies abovementioned and from BD, BioMérieux, Cepheid, and Meridian Biosciences. Vendors supplied the information listed. Readers interested in a particular product should confirm it has the stated features and capabilities.
Anne Ford is a writer in Evanston, Ill.