AACC 2018: Clinical and Diagnostic Companies Stress Integration and Partnerships

The American Association of Clinical Chemistry (AACC) hosted its 70th Annual Scientific Meeting & Clinical Lab Expo in Chicago, Illinois, from July 29 to August 2.  According to preliminary figures provided by conference organizers, attendance declined 6.5% from last year’s event held in San Diego, California, but increased 2.6% from the 2014 conference, the last time the even was held in Chicago. The conference marked the largest number of attendees at the annual meeting when it has been held outside of California. The total number of exhibitors increased year over year by 3.8% to 819. The 71st Annual AACC Annual Scientific Meeting and Laboratory Expo will be held August 4–9, 2019 in Anaheim, California.

The exhibit hall was a sight to see as clinical lab professionals from around the world came together to discover the latest advances in clinical diagnostics and gain insight into the future of lab medicine and translational research. New products were introduced and new advancements were proudly communicated by many companies, including Fujirebio and MedTestDx. Fujirebio Diagnostics announced that it received FDA clearance for the company’s Lumipulse G B•R•A•H•M•S PCT Assay for testing on its LUMIPULSE G1200. This is a significant event because the Lumipulse G B•R•A•H•M•S PCT Assay aids in clinical decision making as it pertains to antibiotic treatment decisions for patients with suspected or confirmed sepsis and also lower–respiratory tract infections.  MedTest Dx unveiled its new products, MedTest DX’s BA-800M Clinical Analyzer and BC-5390 Hematology Analyzer, described as solutions to common challenges of higher volumes in various clinical testing environments.

Roche showcased several additions to its cobas product line, which featured the 6800/8800 systems and m 511 Hematology Analyzer, both of which demonstrate fully integrated and automated solutions in core labs and hematology, respectively.

Continuing to pave the way for MS in clinical settings, SCIEX Diagnostics unveiled its Topaz Prep Station, an automated workstation for labs regularly processing a high volume of samples. The new sample preparation workstation works with the Topaz LC-MS/MS System, which designed to be easy enough to operate for those new to MS. Michael Jarvis, technical marketing manager, Clinical, at SCIEX, discussed the importance of keeping the clinical lab community abreast with the benefits of MS in the clinical setting. “It’s our job to educate and train the [clinical lab] community on new advancements in technology,” he said. Mr. Jarvis further detailed SCIEX’s commitment to engage the clinical diagnostics community through the SCIEX University, SCIEX’s education portal that offers support, training and continuing education on LC/MS and LC/MS/MS.

On the other side of the exhibit hall, Sysmex celebrated 50 years serving labs with products and solutions in hematology, urinalysis and flow cytometry. Sysmex showcased its ability to provide personalized, convenient lab education through the VIRT (Virtual Instructor-Led Training) training, which is offered as a free and unlimited educational resource. Designed for labs, students are trained by Sysmex’s technical professionals through streaming HD instructional videos on lab technology and workflows. Stephanie Post, senior director of Marketing Communications, Commercial Operations, Training & Development Program Management, for Sysmex America informed IBO of the latest developments in customer engagement. She cited the company’s BeyondCare Quality Monitor (BCQM), designed to proactively detect any issues and alert customers when potential problems with their hematology analyzers. The BCQM can also place a service call on the customer’s behalf if issues are detected.

In an interview with Porex, a supplier of porous polymers used across a variety of areas in clinical sciences, including sample prep for IVD, molecular and clinical diagnostics, liquid handling and microfluidic applications, IBO learned more about their newly unveiled Collection to Detection solutions. Maria DeCapua, vice president of Marketing and BioMedical Sciences, detailed the importance of sample integrity and knowing if a sample is contaminated on the front end, before analysis. Precision is especially crucial when the result of the test could mean the difference between the diagnosis of a terminal or benign illness. Ms. DeCapua explained that, in labs, when a sample is found contaminated after it is tested, it can damage a lab’s operation, and if enough contaminated samples are discovered, a lab’s credibility.  On July 31, Porex revealed results from an independent study that demonstrated Porex’s diagnostics materials hold clinical compatibility for up to seven days. She emphasized that in the face of challenges such as decreasing sample sizes, clean samples void of contaminants are integral to reaching accurate conclusions or diagnoses.

 

Mission Acquisition: Collaboration and Comprehensive Portfolios

IBO also had the opportunity to interview several clinical diagnostics executives on the subject of integration and the latest business developments and acquisitions.

In an interview with PerkinElmer and EUROIMMUN, which PerkinElmer acquired in 2017 (see IBO 6/30/17), Dennis Flannelly, PerkinElmer’s vice president of Diagnostics, along with EUROIMMUN’s CEO Hamid Erfanian and Wolfgang Schlumberger, PhD, vice chairman of EUROIMMUN Medizinische Labordiagnostika, discussed the company’s enriched diagnostics portfolio as a result of the integration of EUROIMMUN as well as the purchase of Vanadis Diagnostics in 2016 (see IBO 4/15/16).

EUROIMMUN specializes in diagnostic products for autoimmune diagnostics, infectious serology, allergy diagnostics, antigen detection, molecular genetic diagnostics and automation. The company offers tests to diagnose a vast array of diseases, infections, bacteria, viruses and parasites, along with emerging viruses (i.e., Zika) using its ELISA products and systems, such as the EUROLab Workstation, which provides a fully automated processing of ELISA.

According to PerkinElmer, EUROIMMUN’s portfolio EUROIMMUN is designed to provide its customers with what they need on a custom basis, with menus of tests based entirely on the needs and demands of a given laboratory. As Mr. Erfanian stated, “Laboratories are looking to have partners who understand what they need. We look to provide the customer with a personalized service.”

Vanadis Diagnostics, a provider of non-invasive prenatal testing (NIPT) products, endeavors to make accurate NIPT solutions accessible for all women and simplify NIPT through the use of its proprietary enzymatic sample preparation tools. This sample preparation technique creates and quantifies fluorescent DNA, eliminating the steps involving complex DNA sequencing or microarrays. Vanadis’ NIPT platform also offers a complete solution and processes the entire test (sample to result) without the need for extensive technician supervision.

In an interview with IBO, Gus Salem, group president of the Scientific Fluidics & Optics Group at IDEX Health & Sciences, discussed the company’s latest business developments, including the acquisition of Finger Lakes Instrumentation (FLI), announced on July 25, just days before AACC. FLI provides low-noise, cooled CCD and high-speed, high-sensitivity, cooled CMOS cameras for scientific and astronomical imaging, complementing the existing IDEX portfolio of solutions for the life sciences and analytical instrumentation markets. As Mr. Salem told IBO, “FLI is a great strategic fit in terms of our [IDEX’s] product portfolio.” In another acquisition to complement an existing product line, last year, IDEX acquired microfluidics company thinXXS Microtechnology, a microfluidic consumables business serving the life sciences, point-of-care and veterinary markets.

Discussing these acquisitions, Mr. Salem noted that the range of industry applications that exist for technological innovations in the IDEX product portfolio uncover additional possibilities in fluidics and microfluidics, and FLI opens doors as a supplier of solutions used in furthering research in astronomy. As the clinical diagnostics and instrumentation market dynamic shifts to servicing industry partners in an advisory or consultative capacity, an increased focus on partnering and collaboration is what will ultimately drive IDEX, he explained and its extensive network of solutions, products, brands and industry partners forward.

In the press conference hosted by Roche Diagnostics, Roche Diagnostics CEO Ron Diggelmann, Jack Phillips, the president and CEO of Roche Diagnostics North America, and Justin Bruek of NorthShore University Health System spoke in depth about health care information management. Throughout the briefing, Roche cited several acquisitions and partnerships, conveying that collaboration is an integral part of their strategy for the future. The acquisitions and partnerships were depicted as part of a continuum involving multiple variables: research, laboratory, clinical settings and payers.

The company’s recent acquisitions of Foundation Medicine, Flatiron Health, Viewics and Navify, as well as its partnership with GE Healthcare were noteworthy mentions throughout the meeting.  One commonality among the acquired entities is that they generate and house a tremendous amount of patient health information and data that can be used to overcome challenges in the gray area of reimbursement to solving for unmet needs in cancer diagnostics and personalized medicine. With these acquisitions and partnerships comes the challenge of managing data, and leveraging that information to make better clinical decisions and yield improved patient outcomes. The partnership with GE conveys the commitment to this effort by developing a clinical decision support platform that will integrate in-vivo data from medical imaging provided by GE and Roche’s in-vitro data from their biomarkers, genomics and sequencing and tissue pathology products. As Mr. Phillips stated in the session, “Our intent is to provide tools and solutions to make sense of all of this [data].”

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