Almac Diagnostics, a Craigavon, UK-based firm, last week said that it has extended and widened an agreement with Affymetrix that will allow Almac to develop diagnostic products using Affy’s microarray technology over the next 15 years.
Almac, formerly known as ArraDx, signed an initial agreement with Affymetrix in 2005 to develop tests for breast cancer and colon cancer (see BAN 10/26/2005). Now the company has obtained the right to develop prognostics and diagnostics for all cancer areas with a long-term contract that the firm said will raise its profile among potential biotech and pharmaceutical customers.
“It was important to us to expand our product portfolio [so] that we had the right [to develop tests] for all cancer areas,” Paul Harkin, president and managing director of Almac Diagnostics, told BioArray News last week. “This means that we can move forward with our own internal in vitro diagnostics portfolio.”
Almac has designed a line of disease-specific arrays, or DSAs, for a number of conditions, including breast, colorectal, lung, prostate, and ovarian cancers, that it sells as research tools with a long-term goal of developing them into diagnostics.
The firm currently has three gene-expression signature-based tests in its pipeline based on the DSAs that could become commercially available within the next two to three years. The most advanced test is for stage 2 colorectal cancer recurrence and Almac is preparing to submit the assay for 510(k) clearance by the US Food and Drug Administration sometime next year (see BAN 5/29/2007).
In addition to the stage 2 colorectal cancer recurrence test, Almac also has diagnostics in development for stage 1 lung cancer and ductal carcinoma in situ, an early stage of breast cancer. Almac is collaborating with Cancer Research UK on a discovery project related to DCIS (see BAN 8/7/2007). Depending on the launch of the colorectal test, Harkin said it is possible that both the lung cancer test and the test for DCIS could become available during 2010.
All of Almac’s DSAs are designed to work with tissue from formalin-fixed, paraffin-embedded samples — an attribute that Harkin said has allowed the firm to line up a number of collaborators as its first three assays make their way to market.
In terms of the colorectal cancer recurrence test, Harkin said that Almac is working with “dozens” of centers to generate the data needed for a 510(k) submission. Partners include Massachusetts General Hospital, the University of Calgary, the Karolinska Institute, Queen’s University Belfast, Georgetown University, and St. Vincent’s Hospital in Dublin. Almac announced a collaboration with MGH to screen colorectal polyp tissue samples last April (see BAN 4/10/2007).
“We see ourselves as a company providing a pipeline of diagnostics to partners.” re
Ultimately the colorectal cancer recurrence test will be validated by a “major cooperative group” in the US, Harkin said. “We have an approval path agreed with the FDA, and we would hope to have that test launched by the end of 2009,” he said.
Almac’s lung cancer test is designed to identify patients with early stage, non-small-cell cancer. Harkin said that there are “over 200,000 patients diagnosed” with this kind of lung cancer worldwide each year, so he believes that a test for early identification will play in a “sizeable market.” Almac is working with 10 international centers, including Queen’s University Belfast, the University of Turin, and MD Anderson Cancer Center. “Based on our time lines for [the] colorectal [test], we think this test will be ready for commercialization in early 2010,” said Harkin.
Finally, Harkin said that it is in the process of designing a two-phase study for developing and validating its DCIS test. He suggested that the test could become available by late 2010. In addition to the tests for colorectal cancer, lung cancer, and DCIS, Almac also is at work on a test for prostate cancer, Harkin said.
According to Harkin, Almac does not intend to commercialize its first tests alone. Instead, he said the firm is in “advanced negotiations with a couple of large diagnostics companies” to license the stage 2 colorectal cancer recurrence test.
“We see ourselves as the innovator and solution provider because we have technology, but we want to be absolutely sure that we have a clear route to commercialization,” he said. “We see ourselves as a company providing a pipeline of diagnostics to partners.”
Almac Diagnostics is a division of the Almac Group, a 2,000-employee drug development services company with offices in the UK and the US. Almac Diagnostics employs around 100 people, 75 of whom are in Northern Ireland and the other 25 in Durham, NC. Harkin said that Almac sees the Durham facility as a launching point for marketing its tests to another group of clients — pharmaceutical and biotech companies.
This is where the lengthy contract with Affymetrix will come in handy for Almac, which needs to show its potential customers that it can provide chips over an extended period of time.
“We work with partners in those industries to provide companion diagnostics, and we wanted a mixture so we could cover broadly all type of cancer types,” Harkin said. The agreement with Affy “confirms our supply of those arrays for the long term, which allows us to provide DSAs to our partners in the long term as well,” he said. “It is this kind of commercial agreement that ensures that we have access to the technology and so do our partners.”
Harkin declined to name Almac’s pharma and biotech clients. He said that they are mostly using Almac’s chips for discovery work as well as biomarker validation. Harkin added that these firms are using Almac’s DSAs to stratify sample populations during clinical trials.
According to Harkin, Almac’s ability to work with FFPE samples as well as fresh frozen samples has made it an attractive partner for pharmas and biotech. FFPE is the “manner in which most clinical samples are stored,” he said. “If you want to design the right kind of validation study, you need access to older materials. The ability to go back and mine data sets from paraffin is quite powerful.”