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NIH Seeks Partner to Commercialize Low-Cost Tissue Microarrayer


By Justin Petrone

The National Institutes of Health is looking for a partner to commercialize a new tissue microarrayer that its inventor claims could cost one-tenth the price of similar instruments on the market.

The offer, listed as "Simplified Tissue Microarray Instrument for Clinical and Research Settings," is available under NIH's technology transfer contract program, an initiative under which NIH licenses technologies to small businesses with the aim of moving them into the marketplace.

The agency said it is willing to spend up to $1.7 million over the next three years to develop the arrayer. Stephen Hewitt, chief of the Tissue Array Research Program at the National Cancer Institute, said he developed the device because he was dissatisfied with the capabilities and high costs of existing platforms.

"Nobody can afford the technology [on the market today], and I want something cheap," he said. "When I was in graduate school, PCR machines were $50,000 and each lab had one and every one had to sign up to use it. Now every postdoc has a PCR machine on his desk. That is my paradigm: I want every laboratory that needs a tissue arrayer instrument to have one."

Hewitt said the tool, which when finished will be able to array both frozen and formalin-fixed paraffin-embedded samples, is a "very simple" template arrayer that anybody without "extra skills" can build.

"Instead of trying to control a complicated instrument with moving parts, it is more of a jig," he explained.

Hewitt is the lead inventor on the patent covering the technology, US Patent No. 7,854,899, entitled, "Template methods and devices for preparing sample arrays." It was issued Dec. 21, 2010.

According to the patent, the claimed methods include placing a recipient block with receptacle holes over a first surface, and a template that contains corresponding openings.

Through those openings the instrument can array samples via needles or punches that are inserted into the receptacle holes in the recipient block, the patent adds.

In the contract proposal summary, the NIH says such tissue microarrayers are needed to "validate the accuracy" of diagnostic immunohistochemical assays.

"In the clinical setting, most new diagnoses of cancer use immunohistochemical assays of tissue samples to support the diagnoses, and these immunohistochemical assays must be carefully calibrated and validated," it states.

The NIH envisions two phases for paying the contract recipient to help develop and commercialize the arrayer: The first, estimated to last nine months, will pay the partner $900,000 to help develop the arrayer, while the second will pay it $1.5 million over two years to begin selling it.

Proposals are due Nov. 7.

NIH's offer also specifies what the contract recipient is expected to deliver over each phase of the project. During the first phase the contractor will be responsible for developing a prototype instrument that can fabricate replicate arrays on a microscope slide with a 100-sample capacity for immunohistochemical analyses

The contract recipient is also expected to provide controls for immunohistochemistry and clinical assay validation. Finally, the recipient must provide "process and cost estimates for manufacture of the minimum number of tissue arrayers to accommodate 10 percent of the current market."

If the NIH determines that the contractor has fulfilled its expectations for phase I, the contractor can continue on to the second phase, where the multi-recipient-block tissue arrayer will be "capable of daily run, large core, low multiplicity immunohistochemical controls" and "capable of immunohistochemical assay validation for use with samples of moderate core size and scalable multiplicity."

Additionally, the arrayer should be "capable of fabricating arrays in substrates other than paraffin blocks, including, but not limited to, other solid or semi-solid embedding substrates and frozen materials," the proposal states.

The contractor will also be expected to "provide data on the use of the tissue microarray by research facility staff for routine analytic protocols and of staff training in using the prototypes, as compared to other comparably priced arrayers." Lastly, it will be required to develop a "robust and scalable process" to manufacture the arrayer.

'Demand is Still There'

A number of companies currently sell tissue microarrayers. One is Sun Prairie, Wis.-based Beecher Instruments, which offers its Manual Tissue Arrayer, or MTA-1, which enables "relatively easy construction of tissue microarrays with several hundred specimens," according to the firm.

Beecher also offers its Automated Tissue Arrayer, or ATA-27, which "eliminates the tedious manual punching procedure from array construction workflow," according to the firm's website.

The tool creates array blocks automatically using robotics to measure block heights, retrieve donor tissue cores, create holes in paraffin matrix, and deposit tissue cores into holes. Additionally, the ATA-27 can produce up to 26 replicate array blocks in a single run, the firm claims.

Both instruments are distributed and supported by Estigen, a Tartu, Estonia-based biomedical research-equipment manufacturer.

Another tissue arrayer vendor is Pathology Devices, based in Westminister, Md., which sells a semi-automated platform called TMArrayer. While position movements are controlled by an automated touchscreen interface, the extracting and placing of donor cores remains under user control, the firm states.

Hewitt criticized such offerings, stating that they cost around $12,000, and that his arrayer could sell for as little as $1,200.

However, tissue microarrayers' high costs haven't stemmed demand for them. Hewitt said that his lab has outsourced the production of more arrays in recent years as researchers prefer this method. Given the government's view of the technology, Hewitt said that he expects demand to continue to increase.

"People are buying tissue microarrays, but recent guidelines for immunohistochemistry in a clinical setting endorse the use of tissue microarrays for controls and validations," Hewitt said. "Now the [US Food and Drug Administration] is very interested in seeing the technology being used more to improve assay quality. Demand is still there."

Have topics you'd like to see covered in BioArray News? Contact the editor a1t jpetrone [at] genomeweb [.] com.