NEW YORK (GenomeWeb) – When Abbott recently received a CE mark for its most advanced point-of-care instrument, the milestone initiated an inaugural product launch from within a portfolio of next-generation Dx instruments that will soon be available to customers, the firm said.
The instruments are part of Abbott's Alinity family, which consists of diagnostic instruments and tests within the firm's point-of-care, immunoassay, clinical chemistry, hematology, blood and plasma screening, and molecular diagnostics product segments.
Abbott's newly CE-marked instrument, the i-STAT Alinity, is a next-generation, handheld blood testing system that can target a broad range of analytes on multiple cartridges using only two to three drops of blood, and can deliver results in two to 10 minutes, Abbott said. Since November, the instrument has been available for purchase in Europe and other countries that recognize the CE mark.
The next-generation instrument provides a broad menu of tests that allow healthcare professionals to make fast and accurate medical decisions without leaving a patient's side, Matt Bates, divisional vice president of R&D for Abbott's point-of-care business, told 360Dx.
"This is an unprecedented time within our broader Alinity family in terms of the variety and number of instruments that we are developing and bringing to the market," Bates said. "And we now have the first instrument within this family to make it into the market."
At the American Association for Clinical Chemistry Annual Meeting and Clinical Lab Exposition in August, Abbott introduced Alinity as its harmonized family of next-generation systems and said that each Alinity instrument will include features that help institutions, clinicians, and laboratorians "better navigate through a pressure-packed healthcare environment." The i-STAT Alinity is designed to cater to the needs of health systems that are facing pressures to perform testing as efficiently as possible with limited staff and space while also reducing costs, Abbott said.
On the back of the i-STAT release, the firm expects to launch its next-generation clinical chemistry and immunoassay Alinity instruments within the next few weeks, Abbott spokesperson, Rachael Jarnagin, told 360Dx. "We've seen other companies introduce next-generation systems, but there are none launching this number of systems in such a short time," she said.
Throughout 2017, the firm will continue to roll out instruments for other Alinity diagnostic product segments, including blood screening, hematology, and molecular, Jarnagin added.
Through Alinity, the firm seeks to provide a common look, feel, and user interface that flows across a broad range of test methods, so that when users approach an Alinity device they know what they're going to get. "Users know that they will receive a high-quality result, an intuitive user interface, and a common theme, approach, and menu across multiple devices that makes their workday more effective and efficient, and that transfers into better patient care," Bates said.
The i-STAT Alinity is Abbott's first CE-marked instrument within the Alinity family of next-generation instruments.
It runs tests for 19 analytes using 12 cartridges, including blood gases (such as oxygen and carbon dioxide levels) and blood chemistry (such as glucose and sodium levels). The firm is adding tests for coagulation (such as hematocrit and hemoglobin levels), and cardiac and pregnancy, for which it will use immunoassay technology.
The current-generation i-STAT instrument, the i-STAT 1, was launched in 1991 and is present in one out of every three hospitals in 55 countries, Abbott said. It tests for 26 analytes using 19 cartridges, spanning blood gases, blood chemistry, coagulation testing, and immunoassays.
"We have the broadest menu of tests available on a single hand-held device," Bates said. "And we'll continue to build that menu on the i-STAT Alinity through the release period."
For now, the team is focused on a delicate balance of getting the current menu of tests as soon as possible to customers while adding other tests to that menu, he added.
Bates noted that the range of tests on the i-STAT Alinity could be expanded to tests for brain injury, infectious disease, oncology, and others. The instrument is future proof so that multiple types of test methods can be implemented over time, he said. Molecular tests are under consideration, for example, but the team has not yet committed to developing them for the i-STAT Alinity.
Bates said that discussions are ongoing with the FDA related to receiving clearances for i-STAT Alinity tests after receiving 501(k) clearance for use of the i-STAT Alinity instrument with a sodium assay in July. The firm also is pursuing CLIA-waved status on several cartridges.
The firm expects that the platform's users will appreciate its intuitive nature and ease of use, which are extremely important for point-of-care use, said Bates. The device incorporates haptic features that are activated to make the user aware when test results are out of range, and it also provides advice to the user on follow-up actions as well as guidance that takes the user through how to apply the test.
For people who work in administration and management at clinical care settings, the system provides options that help with managing a fleet of instruments, Bates said. People who work in these positions need to know where instruments are located, that data are being properly collected, that actions are being implemented, and that somebody can take the appropriate action if the test demonstrates an out-of-range result, he added.
The instrument also includes features that help the user achieve regulatory compliance, he said. Only trained users can interact with the test because they must supply personal identification prior to initiating testing.
Competing in point-of-care
Abbott competes within the point-of-care market segment with several diagnostic tests including immunoassay-based rapid tests and molecular tests. The firm reported $473 million in POC diagnostics sales in 2015, a 10 percent increase over the previous year.
Bates said he believes that Abbott's i-STAT Alinity will enable the firm to stand out from competitor's offerings because of its breadth of menu options.
"When you look at most other options with a menu as broad as this, they are core lab analyzers or networks of large instruments that sit inside hospitals," he said. "The next category of alternatives are those instruments that sit on a bench in a stat lab, and because they are static, samples need to be transported to the instrument."
Among its competitors in the market are Abaxis, Siemens, Cepheid, Quidel, BioFire Diagnostics, and Roche, among others. Some of these companies have a presence only in the molecular point-of-care testing space, while others compete in more traditional markets of testing for things like cardiac markers, blood gas testing, and urinalysis.
Abbott's point-of-care testing business was poised to get a boost from Alere, which has a broad point-of-care testing portfolio and which Abbott agreed to acquire early last year for $5.8 billion. However, last week Abbott filed a complaint in the Delaware Chancery Court seeking to terminate the deal, citing numerous events since the agreement was signed that has damaged Alere's business.