NEW YORK (GenomeWeb) – EliTech, a manufacturer and distributor of diagnostic products, is currently validating a benchtop sample-to-answer quantitative PCR platform and a menu of assays for pathogen detection during transplant monitoring.
The platform, called Elite InGenius, would be EliTech's first commercial molecular diagnostics instrument system and has a number of unique features that could make it competitive with more established sample-to-answer offerings.
EliTech is perhaps best known as a reagents supplier, but the firm has been working on the new platform for about two years, Audrey Estampes-Barthelemie, international product manager for molecular diagnostics at EliTech Group, told GenomeWeb.
"It will be the first sample-to-result solution with a menu dedicated to transplant monitoring," Estampes-Barthelemie said. The company's tests are already developed and validated on other PCR platforms, so it will be possible for EliTech to "quickly and rapidly introduce a very complete CE-IVD menu for transplant monitoring," she added.
EliTech's ELITe MGB line of CE-IVD approved assays includes tests for common transplant-associated viruses like Epstein Barr and BK virus, as well as viruses in the herpes family, such as varicella-zoster, cytomegalovirus, and herpes simplex viruses 1 and 2. The firm's assay for Staphylococcus aureus and methicillin-resistant S. aureus, however, is the only one in the MGB line that is cleared by the US Food and Drug Administration.
The Elite InGenius is an integrated platform dedicated to molecular diagnostics, Estampes-Barthelemie said. It is able to automatically perform nucleic acid extraction with magnetic beads, followed by PCR amplification, and results analysis. Total hands-on time is "reduced to a few minutes," and is guided by a touchscreen interface.
Sample preparation begins with direct loading of a primary sample tube. Users can then mix and match three kinds of pretreatment: chemical treatment with lysis buffer, heat treatment, and sonication for difficult sample matrices. Elution is then done in a dedicated tube, so users also have the option to remove the purified nucleic acid from the system prior to PCR.
The latter step is not a feature of other products, Estampes-Barthelemie said. "If we compare it to all other CE-IVD sample-to-result instruments currently available on the market, it's a pretty unique feature."
The universal extraction also employs a ready-to-use cartridge, which the platform automatically pierces during processing, "so the user has only to load the cartridge in the instrument," Estampes-Barthelemie said. The same cartridge is used for genomic DNA, and for viral DNA and RNA, regardless of the matrix or application for transplant monitoring, and the process takes about 30 minutes.
The platform is organized with 12 parallel and independent tracks, and has a dozen independently controlled unitary thermal cyclers. This means that during the same session a user can chose different thermal profiles for each of the 12 samples, Estampes-Barthelemie said. "You can also have master mix with different kinds of chemistries," she said, such as MGB probes in one track and TaqMan in another.
The system also has a pipettor that enables parallel PCR tracks to start from a single extracted sample.
Each unitary thermal cycler, meanwhile, has six different optical channels, allowing for detection of up to six different targets per reaction. Users can also run laboratory-developed tests on the platform during the same run, essentially allowing for "a virtually unlimited menu," Estampes-Barthelemie said.
The BD Max from Becton Dickinson would be an example of a comparable platform currently commercially available. However, that platform does not allow multiple independent PCR reactions in parallel or removal and storage of extracted nucleic acid, and it has five optical channels versus six on the EliTech platform, noted Estampes-Barthelemie.
Another point of contrast is EliTech's quantitative CE-IVD applications. "That's not the case at the time being for the BD Max; if you look at the literature, there are several [BD] customers who have developed quantitative laboratory-developed tests, but their menu currently doesn't have any quantitative assays."
In terms of sample-to-result assays, Cepheid's GeneXpert and the upcoming Luminex Aries platform might also be comparable, "but no one at the time being is able to provide a complete transplant monitoring menu, and in general they provide only a qualitative menu," Estampes-Barthelemie said, adding that in terms of menu and flexibility EliTech has "a unique position."
The firm has already placed a few platforms in external labs for validation purposes and promoted the system at the Clinical Virology Symposium and the European Congress of Clinical Microbiology and Infectious Diseases, yielding "very nice feedback and nice potential opportunities," Estampes-Barthelemie said.
EliTech is based in France but has offices elsewhere, including Belgium and the Netherlands. The R&D for this platform was also conducted in the US and Italy.
Estampes-Barthelemie said the initial plan is to launch the platform and assays "very soon" in Europe as a CE-IVD marked system. The firm is also on track for clinical trials in the US, but declined to provide a specific timeline for FDA submission.
However, "It's not a European platform," Estampes-Barthelemie asserted, adding, "We have a strong plan for the US and we would like to use our presence in the US, where we believe that we have a strong opportunity in this market."
EliTech is also considering future applications for healthcare-associated infections such as MRSA and Clostridium difficile she said.
Transplant monitoring market
There are about 20,000 organ transplants in the US per year and about as many hematopoietic stem cell transplants. Currently, there are 123,300 organ transplant candidates on waiting lists, and 2,311 organ donors in January through February of this year resulted in 4,743 transplants, according to the US Department of Health and Human Services.
Transplant recipients are given immunosuppressant therapies to prevent rejection of the new tissue, making them vulnerable to infection. Common latent infections, like EBV and HSV, can also recur and turn fatal if not attended to.
Pre-emptive transplant monitoring — an alternative to giving the recipient expensive and toxic antiviral prophylaxis — is usually done weekly to catch the first sign of viral replication prior to the onset of clinical disease. The best method is quantitative PCR and quick turnaround time for lab tests is important because viral doubling time can be unpredictable.
The tests, therefore, must be both routine and sensitive. A recent study reported by GenomeWeb found that digital PCR, a highly sensitive technique, has potential but is still too small-scale and labor-intensive to use for routine monitoring of cytomegalovirus in transplant patients, for example.
A study last year in the journal Clinical Transplantation suggested that using World Health Organization international standards might enable better comparisons of viral load measures between labs, but also highlighted the diversity of methods used in the field. Each of the five different clinical labs in the study used different nucleic acid extraction methods and a mix of different amplification and detection platforms.