"The Biomarker Generator is an integrated particle accelerator, kit-based microchemistry module and quality control," says Tom Welch, the company's president and CEO. "It's a low power accelerator, built around the concept of producing unit doses rather than a large batch of F-18. The Biomarker Generator's specification is to produce 20 millicuries of F-18 in 20 minutes, which will then be synthesized into FDG."

The Biomarker Generator fits inside a space of 300 square feet and doesn't need much additional infrastructure or extra staff support. A mere push of a button initiates the cyclotron bombardment, delivers the isotope to the chemistry module, where it is synthesized into FDG and then moves through the quality control (QC) process. At the conclusion, the operator receives the dose ready for injection. Since the system is integrated, it doesn't require any supplementary equipment or complex chemistry knowledge.


"Everything about PET is difficult. You've got a product that decays as you make it, you have a large radiation exposure burden that you have to deal with, you have complex reimbursement, you have a highly qualified trained staff that you have to hire, train and keep motivated," says Welch. "This is a way to make PET more easily accessible, simple to integrate and an economical entry point."

Still, the Biomarker Generator is not meant to be a competitor to commercial FDG suppliers in the United States. The product is generating a lot of interest in emerging markets that don't have access to PET, advanced imaging centers that are looking for more than just FDG and drug development programs that want to integrate PET into their businesses.

"For us, this is a new market," says Welch. "We're not really competing with a large conventional cyclotron, it's really creating a new market."

Anyone who invests in a cyclotron should expect to see a price tag that hovers over $5 million. The Biomarker Generator is anticipated to cost much less.

"We expect that it will be around 25 percent of the initial investment required for a conventional cyclotron," says Welch. "The ongoing operating costs will be even less than that considering the small footprint, low power and lack of requirement for additional staff for operation."

When the Biomarker Generator is able to produce C-11, it will create the possibility for the introduction of a commercial C-11 PET tracer to the market, says Welch. At this point, C-11 is not considered a strong candidate because of its 20-minute half-life.

"To me, it's going to change the way PET biomarkers are produced and qualified. When you have an integrated quality control model, there's no need to buy all the specific individual pieces of QC equipment. It will give people the access to PET in ways that they've never had before," says Welch.

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