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Nuclea Bio Plans Entry into Clinical Proteomics with Launch of Mass Spec-based Assays in 2015

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NEW YORK (GenomeWeb) – Seeking to capitalize on a market that has proven elusive for other companies, Nuclea Biotechnologies is moving into clinical proteomics with plans to offer mass spectrometry-based assays later this year, officials from the firm told GenomeWeb this week. 

Last week, the Pittsfield, Mass.-based firm announced the hiring of six people from Thermo Fisher Scientific's Biomarker Research Initiatives in Mass Spectrometry (BRIMS) Center, continuing Nuclea's transformation into a commercial business from an R&D operation, and in advance of the company's planned launches of its first mass spec-based tests. 

Nuclea President and CEO Patrick Muraca told GenomeWeb that the firm is now clinically validating a mass spec-based test for quantifying native insulin and its therapeutic analogs and another for type 2 diabetes. The company's first assays are expected to be available this year, though Muraca declined to be more specific. 

It initially will offer its products as laboratory-developed tests to be run at its CLIA laboratory. Eventually, Nuclea plans to develop the tests into ELISA-based kits for other laboratories to use, and possibly as mass spec-based kits for facilities that have the instruments. 

Muraca added that the firm is also considering seeking FDA approval when the company begins offering the tests as kits. 

While to date Nuclea has offered only protein-based tests in an ELISA and immunohistochemistry formats, the company has dabbled in mass spec-based proteomics for several years, starting in 2011 when it and Clark University announced the creation of a center to use proteomic and metabolomic methods for biomarker research into cancer. More recently, Nuclea and Thermo Fisher entered into a two-year deal last June to develop and eventually commercialize mass spec-based insulin assays.

Muraca said that as the firm looked at the proteomics space, it saw "a huge opportunity" for proteomics assays in the fields of cancer, metabolic syndromes, and cardiovascular disease, as well as liver disease and kidney disease. Additionally, such assays would have diagnostic and prognostic use, as well as use for monitoring disease and as companion diagnostics, he said. 

Nuclea COO Mary Lopez, one of the hires from BRIMS, said that in adding mass spec-based methods to the company's test portfolio, it will be using the approach to complement Nuclea's existing technologies "and really give Nuclea an unprecedented breath in the proteomics clinical diagnostics field." 

Nuclea's strategy is to develop mass spec-based tests for disease indications for which ELISA and IHC tests aren't specific enough. "And so we're going to be very pragmatic about what tests we develop and how we handle the complete portfolio," Lopez said.  

In seeking a spot in clinical proteomics, Nuclea is moving into a challenging market that few firms have been able to navigate successfully. Companies that currently offer mass spec-based proteomic tests include Biodesix and Integrated Diagnostics. Meanwhile, Caprion, Sera Prognostics, and Applied Proteomics are also developing such tests. 

According to Lopez, though, both the instrument technology and sample prep technology have advanced significantly in the past few years "and the ability to multiplex and to bring a more robust type of workflow into a clinical diagnostic environment has only recently come about. … For protein-based mass spec-based assays, I think you're going to see that we're reaching an inflection point here, and this is just going to increase now exponentially." 

Most protein-based tests are ELISAs and immuno-based, but "for a lot of these diseases that are complex — like metabolic syndromes, like diabetes, like cancer — the ability to very accurately measure and quantify specific protein isoforms is a need and the only way to do that right now is [by] using a mass spectrometer," she added. 

Along with Lopez, others joining Nuclea from BRIMS are Bryan Krastins, Maryann Vogelsang, and Gregory Byram. Krastins is now director of Nuclea's CLIA proteomics lab, Vogelsang is director of bioinformatics, and Byram is a senior technologist in clinical proteomic discovery. 

The firm also has hired a clinical proteomics manager and a director of business and biomarker development. Both are from BRIMS, though Nuclea has not yet publicly identified them. 

Lopez and her team will be responsible for increasing the adoption of all of Nuclea's tests, those that are mass spec-based as well as those that are not. 

At BRIMS, Lopez and her colleagues focused on developing workflows and applications for mass specs in the clinical environment. While Nuclea will use some of those workflows, it will also use workflows developed elsewhere.   

"Certainly we will build on some of the workflows and the applications that we developed for collaborators and customers at the BRIMS, but these are really only a starting point," Lopez said. "Because we are going to be in a much more regulated environment and a CLIA environment, we will have to [bring] different aspects to the actual technology and workflows that we apply here." 

The mass specs that Nuclea is using are Thermo Fisher's TSQ Vantage triple quadrupole and its Q Exactive Plus hybrid quadrupole Orbitrap. Other platforms from other vendors may be added to the mix in the future, Lopez said. 

To fund its proteomics goals, Muraca said that about half of the company's R&D spending will be directed at its mass spec tests, with the other half going toward its ELISA and IHC tests. For 2015, he forecast revenues of $12 million for Nuclea from its mass spec-based tests and its other tests.

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