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Formerly GE Healthcare Life Sciences, Cytiva Moves Into Dx Arena to Help Startups Develop POC Tests

NEW YORK – Cytiva, formerly GE Healthcare Life Sciences, has long been a provider of diagnostic components, such as membranes for lateral flow devices and components for RNA extraction.

But in the wake of its $21.4 billion acquisition by Danaher last year, the subsidiary is moving further into the diagnostic space with a new service to help laboratories and diagnostic firms accelerate their test development. Cytiva helped drive up Danaher's third quarter revenues, in particular its life sciences segment revenues, which were up nearly 19 percent year over year. While Cytiva has no plans to start developing or selling its own diagnostic tests, Emmanuel Abate, VP of genomics and cellular research, said the new service is an "extension of our capabilities."

The company, which has diagnosic component manufacturing sites in Germany, China, and the UK, is building a laboratory in Germany, where it will be able to do end-to-end assay design, including some level of manufacturing, Abate continued. The German lab will be located in the same area where Cytiva manufactures its membranes and other components and will be focused specifically on rapid, point-of-care immunoassays, since that's the space the German operation specializes in. The firm is also working to duplicate its infrastructure in Asia, where it would provide help with both immunoassays and molecular diagnostic tests, he said.

"We're not a diagnostic company developing our own assays, but what we do is provide the components, some essential components, that go into these assays," he added. As customers have requested more help from Cytiva, the company has decided to deliver two different broad offerings – education, including workshops and tutorials to share the basics of starting test development and potential pitfalls; and actual development help, where Cytiva would work collaboratively with the customer to extend resources and "basically be an extension of their R&D team," Senior Product Leader Lee Jenkins said. 

"We can be very specific on what we help them with, so it's all about partnering with the customers to help people who aren't so familiar with this space, sharing our knowledge and to help them get the product onto the market in the best way possible," Jenkins said. In the past, Cytiva has been able to "serve our customers, to co-design with them," Abate said. "But to be very honest, we worked more on an ad-hoc basis." The new diagnostic service would provide more capabilities and allow Cytiva to do more for its customers.

The COVID-19 pandemic has caused many new companies to crop up while encouraging some start-ups to pivot to SARS-CoV-2 testing, and Cytiva believes it can help those companies with test development, especially in areas with which those companies are not familiar. Many of these companies don't have the infrastructure to produce their tests at high volumes. 

"Typically, when you're talking diagnostic tests, we've seen customers we work with take two to three years to get through development and get a product on the market," Jenkins said. "Our service is about accelerating, to get through to the market as quick as possible with the best product we can." Jenkins also said the diagnostic service is targeting start-ups or small companies entering the space as a customer base, people that may not have access to a full diagnostics lab.

Abate seconded Jenkins' comments, adding "It's really about providing more capabilities and the ability to work closely with customers to accelerate the development of their infrastructure," as well as providing smaller firms access to existing infrastructure to continue test development.

For many diagnostic firms. its sustainability as a business is an open question, and especially during the coronavirus pandemic, SARS-CoV-2 testing has provided an opportunity for many new firms to flourish. "The question is for those new entrants, is it going to be [only] opportunistic for a couple of years under certain regulatory accelerated processes, or is it something that will then be sustained with time." Abate said.

Beyond the diagnostics space, Cytiva sells products to help develop and manufacture therapeutics, including those used in drug discovery and protein purification and analysis, according to its website. In addition, its products are currently being used in multiple potential SARS-CoV-2 vaccines, Danaher CEO Rainer Blair said on the company's third quarter conference call.

One company Cytiva has been working with is Hutano Diagnostics, a firm based at the University of Oxford working to develop a disease diagnostic and surveillance program for emerging and dangerous pathogens in Africa, including the Ebola and Marburg viruses. Hutano won a diagnostics competition from GE, which resulted in support from Cytiva in developing the firm's lateral flow device. 

The technology is based on aptamers in lateral flow technology, and while team members were experts with aptamers, they were still learning about lateral flow tech. "Working with Cytiva significantly accelerated our learning process and increased our access to resources to use while learning," said Hutano CEO Atherton Mutombwera.

Some of the other help Cytiva can provide is in the regulatory process, such as assistance preparing documentation and putting in a credible submission for tests to regulators like the US Food and Drug Administration. "Knowledge and experience is key," Abate said. "The best people are the people that have done it for many, many, many years."

Manufacturing is another concern Cytiva can help with, since many of these companies may not have the capacity to meet demand for their tests. "You need to be able to manufacture with a repeat quality, sustained quality," but "few people know how to do it effectively and at scale," Abate said. "It's also very much about the supply chain expertise for those key components."

It can also be expensive for smaller companies to try to produce their tests, but Jenkins emphasized that Cytiva already has the expensive equipment and instrumentation these companies may need. "Combining the resources, the materials, the infrastructure, the quality processes, the experience, I think it's bringing all of that together into one package," he said.

When Hutano worked with Cytiva, the services ended with diagnostic device development and there wasn't manufacturing support, Mutombwera said. But the addition of manufacturing with the new service "helps overcome a significant barrier for companies like ours who do not have lateral device manufacturing capacity," he said.

Abate was careful to note that the Danaher acquisition was not the driver behind the development of the service, saying "those capabilities and the plans to do something bigger and with more offering was there pre-Danaher." However, Danaher's expertise in the diagnostic field and in making diagnostic platforms, with subsidiaries Cepheid and Beckman Coulter, as well as its larger reach, helped Cytiva trust the company as it moved into diagnostics. Danaher has also given Cytiva a wider reach and a larger customer base, he said.

Both Abate and Jenkins declined to specify exact pricing for the service, but Jenkins said it would be a fee-based service dependent on what the package of work is. He added that the goal "is not to maximize the revenue from the service charges." "The real incentive is to help our customers get to the market with the best product and then we'll get our return on that for the component sales," and design, he added.

Working with Cytiva will also allow start-ups and smaller labs to share the risk with Cytiva, giving them more freedom than they may have had if they were going it alone. One thing Cytiva has said it will not help directly with yet, however, is funding, although it can connect companies with people in their network who can help, Jenkins said. 

With the pandemic-related restrictions on travel, the services are currently digital, but once those restrictions are lifted it will become a face-to-face service. Companies will be able to travel to Cytiva's German laboratory, or Cytiva's diagnostic experts could come to the company's site, if it has its own site, Jenkins said. 

The education component of Cytiva's services will have a standard curriculum, but customers will be able to customize it depending on their specific needs, Jenkins said. While there are other companies who offer education and development services for diagnostic testing, such as Thermo Fisher Scientific, Jenkins said Cytiva is the only one offering components of the tests directly, which is a value add. Mutombwera said that although there are lateral flow device training courses offered by other organizations, the Cytiva diagnostic service offers more and is "a building block that enables young companies like ours to grow."

Abate said Cytiva's high-value manufacturing franchise is one of the key benefits for companies working with Cytiva, and added the company understands the kind of long-term commitments needed to "bridge the gap from very early stage to an actual product." 

However, Jenkins noted that the ultimate goal of the partnerships between diagnostic companies and Cytiva is to get those companies independent, and "the last milestone in our development packages is transferring the diagnostic company to a manufacturing site that can produce their products on an industrial scale." Although Cytiva will provide maintenance and troubleshooting for a period of time once the company has transferred, the partnership isn't meant to last forever. 

Despite the COVID-19 pandemic speeding up the need for more testing and development help, Cytiva plans to keep the diagnostic service offerings long after the pandemic is over. "This is not wholly on the back of COVID in 2020, this is really something we're committed to and want to replicate success over time," Abate said.