Empowering Labs with Multiplatform Testing Options

Luminex has developed multiple cassettes and assays for ARIES®, the company’s real-time PCR-based molecular diagnostics platform. Cassettes contain extraction, purification, amplification, and detection reagents, as well as Sample Processing Control (SPC). In addition to supplying multiplex panels, Luminex is developing a broad in vitro diagnostics menu. ARIES also allows users to develop their own custom assays.

When labs decided to scale up their COVID-19 testing, they immediately faced a couple of problems. First, tests were not readily available. Second, it was clear that demand would largely exceed capacity even after tests came online.

To meet the challenges posed by COVID-19, labs turn to specialist companies such as Luminex, a supplier of assays and instrumentation. Founded in 1995, Luminex celebrated its 25th anniversary in May, by which time the company had developed multiple technologies and installed thousands of machines throughout the world. All these were ready to respond when the pandemic started.

First, Luminex began leveraging ARIES^®, a PCR-based molecular diagnostics platform that the company had previously validated for laboratory developed tests. Next, the company received BARDA funding to support development, testing, and commercialization of SARS-CoV-2 assays. And then Luminex secured emergency use authorization (EUA) from the FDA for both its NxTAG^® CoV Extended Panel and the ARIES SARS-CoV-2 assay as an in vitro diagnostic product.

NxTAG and ARIES offer increased flexibility to testing labs, enabling them to run high-throughput multiplexed assays as well as single-patient tests. High-complexity labs, for instance, might run the NxTAG bead-based assays to jumpstart their testing throughput. The EUA for that platform “opened testing to anybody who had the instruments,” says Charles Collins, PhD, senior vice president of R&D at Luminex.

Multiple platforms

Collins emphasizes that Luminex is advantaged because it has developed multiple platforms. “Competitors,” he points out, “tend to have only a single platform.”

For more comprehensive testing, labs may run the NxTAG Respiratory Pathogen Panel (RPP) next to the COVID-19 assay. “With 20 viral and bacterial pathogens, plus the SARS-CoV-2 assay, you can determine—cost-effectively—whether a person has COVID-19 or the flu or both or neither.”

Using multiple platforms helps a lab match testing solutions to its personnel’s skills. Less experienced personnel, perhaps newly hired to provide surge capacity, might run the ARIES sample-to-answer platform without special training. This automated molecular diagnostics platform can run up to 144 tests per day, and it can provide results in about two hours. Even before ARIES received an EUA, “customers could use our instruments and develop their own testing,” Collins notes.

Typically, customers are under pressure to increase throughput and contain costs. With COVID-19, those pressures are still there, but the testing demand is increased. “A lab that normally runs 100 samples now needs to run 1000,” Collins observes.

The industry’s move to sample-to-answer instruments eliminated the bottlenecks more complex testing methods may experience around workflow or reagents. However, it pushes potential bottlenecks to the manufacturers in the form of manufacturing throughput, which still requires reagents, buffers, and labware. A spike in demand for those items has been seen across the industry.

For customers trying to integrate Luminex instruments and assays into their labs, the Luminex white papers should be the first stop. If customers need deeper knowledge, they can seek personal assistance. “We have a team of field application specialists,” Collins states. “Customer help is their job.”

A second shift

During the spring, the greatest concern was the sudden spike in the demand for testing.

As soon as Luminex received its first EUA authorization, it began scaling up its production capabilities to meet the global need. “Our employees are working seven days a week, and we added a second shift,” Collins tells GEN. “I’m really proud of our employees. They’ve had to step up to the challenges. They’ve had to do whatever it takes, working outside their normal jobs, to get the job done.”

In some companies, intensified production might result in complications, but at Luminex, the extra effort might lead to improvements because it is occurring across departmental lines. “In quality control (QC),” Collins explains, “the people stepping in are often from R&D. They wrote the QC manual. In manufacturing, we’re pulling personnel from the engineering group that designed our instruments.”

While Luminex is accelerating its own manufacturing throughput, it’s also expanding its product capabilities. Notably, it is adding SARS-CoV-2 detection to its VERIGENE^® II Respiratory Flex Assay.

The VERIGENE platform was being designed by a company Luminex acquired. “That company already was developing a second-generation product, VERIGENE II, so we finished it,” Collins says. “It’s still under review by the FDA.” This is a sample-to-answer multiplex product. You can put a sample into the consumable, put it in the instrument, and get an answer that can be read without special training. Multiple assays are in development.

Made in the USA

In 2018, Luminex acquired MilliporeSigma’s flow cytometry portfolio and is onshoring its production. All Luminex instruments and consumables are manufactured in the United States, although some of the components are sourced internationally.

That allows a higher degree of responsiveness, a point Collins stresses: “If you’re making something yourself, and there are problems, you can bring in the R&D group and figure it out. That’s a huge advantage that goes across everything we do.”

Luminex’ drive to innovate stems from its problem-solving mindset. Its advanced technology group works closely with its strategic marketing group to keep the company well versed in external technologies and innovations and to predict how those innovations will affect the future.

Grounded in multiplexing

The partner model developed by Luminex during the company’s early days is another innovation driver. Initially, it helped the company develop bead-based multiplexing technology, which encompasses beads and the instruments that read them. “The licensed technology group signed up companies that needed multiplexing, covering many areas,” Collins recalls.

Around 2010, he continues, “Luminex decided to go direct to customers in the molecular diagnostics space.” That’s where ARIES and VERIGENE fit.

Then Luminex built an internal sales organization and built out its portfolio through targeted acquisitions. The acquisitions activity culminated in the addition of MilliporeSigma’s flow cytometry business in 2018. “That aligns with our original business,” Collins declares.

For Luminex, 2019 was a rough year. The company lost a major customer and had to work to recover. “At the most basic level, however, our plan is the same as before: building and growing all our different business segments,” Collins insists. Its plan appears to be working. First quarter revenues in 2020 were about 10% higher than in 2019.

This improvement is attributed to the company’s assays and instruments for detecting the SARS-CoV-2 virus. Additional improvement is expected as the company introduces new products. Aside from helping to address coronavirus concerns, Luminex is focusing on bringing the VERIGENE II platform to market. “We have a gastrointestinal and respiratory panel in review with the FDA, and many more assays to come,” Collins says.

“We’re also making a new bead reader, INTELLIFLEX,” he adds. “This flow cytometer is expected to go out later this year to the research community. It’s not a COVID-19-specific instrument, but it has capabilities that could prove very useful in this area.”

Looking forward, he predicts a renewal of research not related to coronavirus. “You’ll see a lot of research funding (from the National Institutes of Health and others) later in the fall. That funding drives our partner business.”

Although the pandemic crisis will subside, the need for testing will continue. For Luminex, abiding demand will keep the company busy well into the future.