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BioArray Q&A: Clinical Microarrays Gears Up for Protein Biomarker Platform Launch

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Natick, Mass.-based Clinical Microarrays announced recently that it had received Series A funding of $7.5 million from investors including Oxford Bioscience Partners, Rock Maple Ventures, Fletcher Spaght Venture Partners, and a group of individual investors led by the firm’s chairman, Jean “Coco” Montagu, a former vice president of advanced technology at Affymetrix, who had provided seed funding for the company. The firm, which was founded in March 2002, is led by a group that worked for firms that had developed DNA microarray scanning systems, including PerkinElmer and Affy. Darren Lee, VP of marketing and sales for Clinical Microarrays, talked with BioArray News this week about the firm’s technology and future plans.

Where did the core technology come from?

The core technology is all self-developed. It wasn’t spun out of anything. Our chairman is a guy named Jean Montagu. He founded General Scanning, he founded Genetic Microsystems, who were working on DNA array tools, spotters and arrayers. The company was bought by Affymetrix for $220-plus million dollars. He worked with them for a couple of years and thought the next kind of growth would be in protein microarrays. Roger Dowd [the president and CEO of Clinical Microarrays] was working with him at General Scanning, and it was just the two of them for a while. There were two other people who came in, consultants, who helped develop the core technology.

Can you tell us more about the core technology?

We tried all of the commercially available slides and the problem we ran into was that you get high signal, but because of the surface — microslides have a lot of autofluorescence — you get a high background as well. So, your noise is proportionate to your signal. What we did was we created a surface that’s not 3D, but a 2D film, and it’s about a tenth of a micron thick of nitrocellulose. It dramatically reduces the background fluorescence, signal-to-noise compared to other surfaces.

Are you developing just substrates?

No. We’re also developing a very small, economical, but powerful imaging system that will read the substrate. Now, we’re not going after the research market — like the Axon or PerkinElmer scanners. We’ve licensed the substrate in its form on a one by three slide to GenTel Biosurfaces in Madison, Wis. They’re going to distribute the slide against the S&S, Corning, and PerkinElmers of the world in the research market. We take a small piece of that and put it in a disposable, bar-coded biochip that is assay-specific. If someone says we want these six protein markers for ovarian cancer, we make an assay for that chip. We supply them those chips and the system to read them.

What are the applications for the products?

We were really targeting initially near-patient diagnostics. Everything from diagnosing problems in the field of fire — in the army — but really in emergency rooms or hospital rooms. All of the things when you need a time-critical diagnosis that can aid the physician in the treatment regime. As we started looking into that, we realized there was a huge unmet need. The panels of biomarkers that are being used for lead candidates in early-stage trials ... the performance that [researchers are] getting now has to be better if they want to take those panels and then push them into FDA submission, as well as maybe pushing [them] out as a companion diagnostic to help physicians determine when to give the drug. That’s how we fell into the whole clinical trials testing, primar-ily safety and efficacy as well as patient stratification.

Will this be used for any gene expression applications?

None whatsoever. All protein biomarkers.

When do you expect a product launch or a beta?

Sometime in June or July next year.

Will you sell the system yourself?

We’ll sell directly to the pharmaceutical and biotech and CROs — the clinical trials segment of the drug development process. We’re in the process of making an offer to a VP of sales right now. We’re guessing right now we’ll have a minimum of four salespeople in the US and two in Europe. It could be larger based on how our volume goes. In the diagnostics world, if we do get to the point where we have diagnostic panels, we’ll have to sign up with somebody. You’ve got eight very large companies competing against each other for hundreds of millions of dollars. With thousands of people on their sales staffs, we couldn’t compete.

How much will the system cost?

I could tell you, but I probably shouldn’t.

Do you have development partners?

We do, but I can’t tell you that either. We’re working with collaborators on everything from proprietary content — there are going to be some assays that aren’t going to be off the shelf — to pharma companies that want to take a biomarker panel and implement them as a diagnostic to see what kind of results they get.

Who do you see as your main competitors?

Initially, we looked at Luminex, BioRad, Pierce, Beckman Coulter, and Zyomyx. Even some of the mass spec pattern recognition programs like those from Ciphergen and Petricoin’s group from NCI.

How about some of the microarray manufacturers that are pushing their way into diagnostics?

The bottom line is that what you saw with the CYP450 chip from Roche — that’s a harder road to hoe. When you try to use that as more than an ASR and you want to get a clinical trial test for that, there’s nothing comparative to that. We run a functional, full-performing ELISA. We just do it very fast. So, you can compare it to a single test ELISA, and I think it’s a little more justifiable and understandable to the FDA. I’m hoping we’re not going to get mired down in the same problem as the CYP 450 chip. That being said, I think a lot of the gene expression companies are going to run into the same problem until regulations get passed that clear it up.

 

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