NEW YORK (360Dx) – In an industry responding to laboratory consolidation and health systems looking to purchase systems that can handle larger volumes and broader test menus, Abbott believes that molecular labs can benefit from moving testing currently done by several instruments onto a single platform.
Its solution to facilitate this change is the Alinity m real-time PCR-based molecular platform.
On the heels of receiving CE marking for the system and a number of assays, Abbott discussed its strategy for positioning the platform at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam last week.
Many of the customers that the Abbott Park, Illinois-based firm is targeting with the Alinity m run up to eight different instruments for testing. That means a costly infrastructure is needed to support so many different platforms, said Khaudeja Bano, head of medical affairs at Abbott Molecular. "You need the footprint, you need to maintain the platforms, you need to train people for each one of the instruments, and they generally don't communicate with each other."
Switching to just the Alinity m, would mitigate such infrastructure demands, she said.
From a lab manager's perspective, Alinity m's random-access testing capability eliminates extensive logistical planning required of managers who currently process tests in batches, often according to a single indication. That feature has the potential to provide significant savings for the firm's hospital and reference laboratory customers and eliminate delays associated with getting lab results to clinicians, Bano said.
The new molecular system prioritizes urgent samples 16 minutes after they have been loaded and then takes 115 minutes to fully process them. Within its integrated reaction units, the Alinity m uses fluorescence to detect either DNA or RNA in samples that have undergone extraction and amplification and provides test results in less than two hours from the time a sample is aspirated, Abbott said.
The firm expects that the system's sample-to-answer automation will enable labs to eliminate many manual processes and let their technicians devote time to higher value assignments such as helping clinicians better interpret test results, Bano said.
A broader menu
Last month, Abbott received CE marking for eight initial assays running on the Alinity m, including virology testing for human immunodeficiency virus type 1, hepatitis B, and hepatitis C; sexual health testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium in a single CT/NG/TV/MG assay; and testing for high-risk human papillomavirus. The system has 20 positions for assay reagents.
Such a menu covers more than 70 percent of testing in molecular labs when measured by test volume, Jens Dhein, Abbott's scientific director of molecular systems, said at ECCMID. "We are seeing molecular tests take a broader piece of the [in vitro diagnostics] market, so our plan is to expand the menu and consolidate as much testing as possible onto this one machine."
The firm, he noted, is continuing to develop new tests that would run on its new molecular instrument. Assays that test for Epstein-Barr virus (EBV), cytomegalovirus (CMV), and respiratory viruses are in various stages of development to run on the Alinity m, for example. The firm is also developing the capability to offer laboratory-developed tests for use on the platform, and it is advancing with development of different sample types for some assays.
In a move that could have an impact on HIV testing in remote settings, the firm is also developing the Alinity m to test dried blood-spot samples, Bano said. Abbott is targeting the Alinity m instrument toward reference laboratories in African countries that would use such samples for HIV detection and viral load testing, she noted.
A blood spot taken from the heal of a patient, for example, can be collected on paper, dried, inserted in an envelope, and shipped to a reference lab without requiring complicated storage. That approach also eliminates risks associated with tubes breaking or spilling when they are being transported, and that kind of "access to the remotest villages is where we see the value" in use of dried blood-spot samples, Bano said.
For Abbott, the launch of its new molecular system in Europe completes a series of Alinity platform introductions that the firm has promised to customers for a few years, and it is the result of extensive customer research conducted by the firm, Bano noted.
Additional platforms in the Alinity series have already received CE marking and/or FDA clearance. The Alinity ci-series of instruments for clinical chemistry and immunoassays, for example, have been on the market for a few years after receiving CE marking in January 2017, followed by FDA clearance in October of that year.
With the Alinity m instrument now also available, Abbott's customers may be able to realize the benefits of combining the molecular system with the other Alinity systems, according to Abbott. Labs frequently detect an infectious disease using the clinical chemistry and immunoassay platform and use molecular testing for confirmation, though the specific protocol varies from one health facility to another, Bano said.
With CE marking in the bag, the firm anticipates that eventually it will receive 510(k) clearance from US Food and Drug Administration to market the system in the US though the timing of clearance is unclear.
Market dynamics
Nonetheless, to gain market share, Abbott will need to convince customers that the Alinity m molecular system can help it better meet testing demand than competing FDA-cleared platforms, and it will encounter other heavy hitters in the high-volume molecular testing market, such as Roche, Hologic, Qiagen, and Becton Dickinson.
Further, lab directors interested in highly multiplexed systems may not be interested in replacing their smaller molecular diagnostic systems with larger, high-volume systems that don't provided the same level of multiplexing, Piper Jaffrey analyst William Quirk said in an interview.
Given that most hospital labs at present are under market pressure due to the Protecting Access to Medicare Act of 2014 (PAMA), labs are more likely than in the past to add highly multiplexed testing to their menus that enables them to capture incremental gains in margin and provider broader pathogen coverage for their customers, he said.
At the same time, "there are certain economic benefits to consolidating those higher volume tests under a single platform, and certainly that's been the strategy of Roche and Hologic, two of the companies that were earlier [than Abbott] in offering fully automated high-throughput systems to the market," Quirk said.
In the molecular testing space, the Alinity m's impact on competitors' market share is likely to be seen in the "long term" and will probably begin to materialize in 2020, Evercore ISI analyst Vijay Kumar told 360Dx. It's been more than a decade since the firm received CE marking for the M2000 automated molecular batch processing platform, the predecessor to the Alinity m. That could leave Abbott at a "significant disadvantage" to peers in markets for high-volume molecular testing, Kumar wrote in a recent research note.
Nonetheless, the Alinity m's small footprint in an era of "labs complaining about space" is a "clear advantage," he said. Many of the initial CE-related approvals on the platform are focused on virology, and therefore, the Alinity is probably going to "take on Roche's Cobas," he wrote.
Other competitors in its sights include Hologic, which offers the Panther and Panther Fusion MDx systems and assays for sexually transmitted diseases and influenza, among other conditions; Qiagen and NeuMoDx, which announced a strategic partnership to offer next-generation systems for fully integrated molecular diagnostic testing with a focus on infectious diseases; and Becton Dickinson, which provides the Viper automated molecular system for detecting sexually transmitted diseases.
Roche got the FDA nod for its Cobas 6800 and Cobas 8800 molecular diagnostic platforms and associated hepatitis B and hepatitis C viral load assays in October 2015, and the firm has continued to receive clearances for assays on its system.
For example, a year ago, Roche received clearance for its Cobas CT/NG assay for use on its Cobas 6800 and 8800 systems. The assay and systems have been cleared to directly detect the DNA of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in symptomatic and asymptomatic individuals.
Both Abbott and Roche have reason to hope their high-throughput molecular systems will drive growth. Roche reported flat sales for its diagnostics division in the first quarter of 2019, driven by decreased sales in the centralized and point-of-care business and diabetes care business that were partially offset by strong growth in its MDx business.
Abbott's molecular diagnostics business has been growing at a pace below that of a peer group that includes Qiagen, Hologic, and Roche, and "we think Alinity m could accelerate this growth," Kumar wrote.