NEW YORK – Becton Dickinson revealed last week that it has acquired NAT Diagnostics, a molecular diagnostics firm focused on rapid point-of-care testing. The NAT Dx isothermal technology will be further developed by BD with an eye toward offering customers decentralized molecular testing options in early 2023.
The deal was signed last year, according to BD, but it was not finalized until last quarter. Terms of the agreement have not been disclosed.
The acquisition was unveiled in a call to recap the firm's first quarter earnings last week, during which BD CEO Tom Polen described NAT Dx as "an early-stage company with a very innovative platform in the fast-growing molecular point-of-care market," a market in which BD currently does not have an offering.
When BD takes the NAT Dx technology to market it will be competing against entrenched competitors such as Cepheid, Roche, Abbott, BioFire, and Mesa Biotech, and perhaps also companies with systems in development, like Quidel and Meridian.
BD CFO Chris Reidy commented on the call that BD has "been very specifically developing additional solutions for the non-acute sector," citing its Rowa platform for medication storage and dispensing in retail pharmacies, and the Veritor system for point-of-care immunoassay testing. This decentralized space is "a faster growing segment," Reidy said, adding, "We'll certainly only increase in that direction going forward."
Reidy also said he expected that the ultimate NAT Dx technology-based platform will have "similar time to resolve" as the firm's lateral flow-based Veritor system. Overall, he described the technology acquisition as an investment BD has made in light of a continuing shift in diagnostics toward testing in non-acute settings.
"We definitely see it as a trend. It's something we've been investing in and will only continue to double down on that as we go forward," Reidy said.
BD already has a strong position in two other spaces where molecular testing is deployed, according to Dave Hickey, president of integrated diagnostic solutions at BD.
Specifically, the BD Cor system is useful to large central labs that need high-throughput testing, Hickey said, while the BD Max system targets STAT and acute test settings, such as hospital-acquired, sexually transmitted, and gastrointestinal testing, which need turnaround times of two to three hours.
But decentralized, point-of-care testing is a third area where there is a large need for molecular tests, so, "It was critical for us to identify a technology and a collaboration in the point of care," Hickey said. "This is a very deliberate part of our strategy to become a leading player in molecular diagnostic infectious disease testing."
Other firms in the POC MDx space are focused on respiratory tract infection testing, such as influenza A and B, respiratory syncytial virus, and Strep A. Hickey said that BD sees potential in also having menu that includes other assays, such as COVID-19, chlamydia and gonorrhea, or bacterial vaginitis and vaginosis.
The firm is looking for opportunities to accelerate the development given the COVID-19 pandemic, he said, but it expects to fully commercialize the platform in early 2023.
Overall, "We have a really nice portfolio now to leverage molecular testing in a highly acute setting, and then also combine that with Veritor … and expand Veritor into non-acute segments like retail and CLIA-waived spaces," he said.
Hickey noted that BD has approximately 28,000 Veritor instruments placed in the US across a mix of acute and non-acute testing sites. The firm will now be able to reach out to those customers with the new, "highly complementary" molecular instrument, although Hickey said that reimbursement rates in different markets and geographies may determine whether customers will wish to bring on molecular testing or stay with the Veritor anchor platform.
BD also has a COVID-19 viral antigen assay in development on the Veritor, as previously reported, and expects to launch that in the coming weeks.
The NAT Dx tech
The patented core technology at NAT Dx involves real-time fluorescence molecular detection and a hyperthermophile polymerase from a single-celled organism.
Andrew Miller, formerly the CEO of NAT Dx and now a director of research and development, said the prototypical enzyme used in the patented technology is a commercially available one called 9°N, pronounced nine degrees north, which is used by archaea found in deep-sea hydrothermal vents near the equator.
"It allows for extremely rapid amplification and detection of target nucleic acids from both viral and bacterial pathogens," Miller said. The platform is also cartridge-based, "to provide an extremely simple workflow that can be used by people who have absolutely no laboratory training." The time to results is in the five-minute timeframe, Miller added.
The NAT Dx platform is fundamentally different than others on the market, and the core technology also differs from isothermal methods like LAMP, RPA, or NEAR, although it doesn't yet have a catchy acronym, he said.
NAT Dx has a legacy in the isothermal point-of-care molecular world. The company's founders, Miller and Honghua Zhang, were previously in charge of Ionian Technologies and had invented the isothermal nucleic acid amplification technology called NEAR. Ionian at one point had signed a deal to develop assays with Roche and received funding from the Department of Defense and the Gates Foundation before being acquired by Alere.
The Ionian NEAR technology was incorporated into the Alere i, which has subsequently become the Abbott ID Now system.
In 2015, the Alere i became the first rapid point-of-care molecular system to be CLIA waived, and it was heralded as a breakthrough. Soon, the Cobas Liat system from Roche and the Xpert Xpress from Cepheid were also designated as waived, enabling their use in more decentralized settings. Systems from BioFire and Mesa Biotech then entered the market with CLIA-waived testing instruments and assays.
The Abbott ID Now Emergency Use Authorized COVID-19 test has recently been criticized for lower-than-expected sensitivity. In general firms in the point-of-care molecular testing space differentiate themselves by whether the platform uses true PCR or isothermal amplification.
However, Miller speculated that sensitivity differences in isothermal-based technologies may in part be related to differences in sample prep, which can affect how much pathogen genetic material is available, as well as the presence or absence of amplification inhibitors. Isothermal tests tend to be done directly from patient samples.
"You have to lyse the bacterial DNA or RNA so it can be amplified and detected, you have to have stability of the reagents, and have an instrument and a cartridge that can combine all that," Miller said. "We feel like we have probably the strongest combination of those features available today, and I would expect the analytical performance to be equivalent to PCR," he said.