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Almac Initiates Talks With FDA; Plans to Market Colorectal Recurrence Dx in 2008

Almac Diagnostics, a Craigavon, UK-based company that has to date offered arrays for research purposes, said this week that it has initiated talks with the US Food and Drug Administration that it hopes will lead to clinical trials and the eventual submission of an array-based colorectal cancer-recurrence test sometime next year.
Almac officials on April 13 met with representatives of the FDA’s Center for Devices and Radiological Health to discuss the "proposed regulatory pathway for the company’s prognostic gene signature for relapse in colorectal cancer."
Based on that Investigational Device Exemption meeting, Almac has decided to accelerate the development and clearance of its colorectal test with the goal of submitting the assay as an in vitro diagnostic for 510(k) clearance perhaps as early as next year.
"The company will now finalize the design of analytical and clinical studies required for US marketing clearance," Almac said in a statement. "While there can be no assurance that FDA will ultimately clear the product through the 510(k) premarket notification process, the company has decided to pursue that route of market clearance based on the preliminary discussions with the agency."
Almac Diagnostics, previously known as ArraDx, has been an Affymetrix GeneChip service provider for years, and recently began introducing its own line of array research tools called Disease Specific Arrays for colorectal, breast, and lung cancer, all manufactured by Affy on its platform. Now the firm is living up to its name by moving forward with the first of what could become several clinical applications.
According to Almac, the company developed its prognostic gene signature for colorectal cancer test entirely from formalin-fixed, paraffin-embedded samples. It is designed to help clinicians determine the risk of cancer recurrence in patients diagnosed with stage II colorectal cancer.
The firm has been developing the IVD for several years. In September 2006, Almac showed a preliminary 42-gene signature for the indication at Discovery 2 Diagnostics in Boston. Last month, Almac said that it will partner with Massachusetts General Hospital to screen colorectal polyp tissue samples in an effort to discover a signature that could help physicians diagnose early-stage colorectal cancer (see BAN 4/10/2007).
Almac CEO and co-founder Paul Harkin told BioArray News in an e-mail last week that the company now plans to work with the FDA to design a clinical study and eventually introduce the test to the US market.
"We hope, subject to further FDA discussions, to submit the CRC Stage II test for clearance sometime in 2008," he wrote. "However the timeframe will depend entirely on clinical study design, which we hope to agree with FDA in the coming months. There can be no assurance that the product will be cleared in 2008," he added.
Through its parent company, the Almac Group, Almac Diagnostics has resources that it can draw upon to develop and market its test in the US. "We have very significant resources at our disposal to deliver the global commercialization of this test," Harkin wrote. Almac also has a "clearly defined commercial strategy," he said, though he declined to elaborate.
Colorectal cancer is the third most prevalent cancer in the US, after breast and ovarian cancer, according to the National Cancer Institute.
Harkin wrote that Almac plans to prepare the test from its laboratory in North Carolina and from its headquarters in Northern Ireland. As it moves forward with clinical trials, the company will probably count on its alliance with Mass General and other partners to provide useful data for the 510 (k) submission.

Through its parent company, the Almac Group, Almac Diagnostics has “very significant resources at our disposal to deliver the global commercialization of this test."

"A number of cancer centers and cooperative groups, both in Europe and the US, have assisted us in development of the range of Cancer DSA platforms and development of this CRC Stage II signature," Harkin wrote. "We will continue to work closely with these collaborators as we move through [the] clinical study phase."

Almac Diagnostics’ previous incarnation, ArraDx, which merged with Almac in late 2005, signed an agreement with Affymetrix earlier that year to develop diagnostics on the company’s GeneChip platform.

Recently, Affy has opened a clinical service laboratory where it hopes to run homebrew versions of tests on its platform before they are submitted for 510 (k) clearance. For instance, Ted Fong, director of market and business development at the Affymetrix Clinical Services Laboratory, told BioArray News last week in an e-mail that the company sees the "potential of [the Affymetrix Clinical Services Lab] as a CLIA lab to be a clinical trial site, a homebrew site, and an early-access site for signatures.”

However, Almac’s Harkin wrote that his company does not plan to introduce its test as a homebrew in the US before seeking FDA approval. "At present our tests have been designed to run on the Affymetrix platform," he wrote. "Almac Diagnostics [is] committed to a regulatory process for development of this test. We have no plans to offer this test in the 'homebrew' format.”

More IVDs and DSAs
In his e-mail, Harkin wrote that as Almac moves forward with the colorectal cancer test, it will continue to develop other clinically relevant gene signatures that may eventually mature into IVDs.
Almac launched its breast and colorectal DSA arrays over the past year, while its lung DSA array became available this spring and, according to Harkin, Almac is working with “a number of collaborators in pharma, biotech and academia” that are using the colorectal, breast, and lung cancer DSAs as research tools “to develop further IVD products.”
"We anticipate that CRC stage II test will be the first in a series of clinical applications to be developed, validated, and brought to market using this technology," he added.
Later this year Almac will launch prostate and ovarian cancer DSAs for research-use only, Harkin said, adding that the company is currently in the process of "identifying key partners" to help develop the platforms.

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