Almac Diagnostics is on track to begin selling in the US its array-based diagnostics for colorectal cancer recurrence and early-stage lung cancer in the next two years, according to a company official.
Richard Kennedy, vice president of research and development at the Craigavon, UK-based firm, told BioArray News this week that Almac is planning to submit the colorectal recurrence test to the US Food and Drug Administration for 510(k) clearance next year, with a lung cancer test submission to follow in 2010.
He added that the company has benefited from a recent expansion in the US market of its parent company, the Almac Group, which has recently broken ground on a new North American headquarters near Philadelphia that is scheduled to open in 2010.
The tests use gene-expression signatures to detect colorectal cancer recurrence and early-stage lung cancer. A third test, for early-stage breast cancer detection, is also under development, though no launch date has been set. All three assays run on Affymetrix’s GeneChip platform, and Almac has been a Powered by Affymetrix diagnostics partner since 2005.
According to Kennedy, the colorectal test will be submitted for FDA clearance next year. The test is designed to help clinicians determine the risk of cancer recurrence in patients diagnosed with stage II disease.
Almac began talks with the FDA concerning the colorectal test in May 2007, and had initially hoped to get the test on the market this year (see BAN 5/29/2007). In April 2007, the firm embarked on a study with Massachusetts General Hospital to screen colorectal polyp tissue samples to identify a signature for early-stage colorectal cancer recurrence (see BAN 4/10/2007).
Lung Cancer Dx
Earlier this month, Almac announced a similar partnership with 15 research centers to develop an early-stage prognostic signature for patients with early non-small cell lung cancer, the most common form of lung cancer.
Among Almac’s 15 partners are Queen's University Belfast, UK; the University of Turin in Italy; St. James Hospital in Dublin, Ireland; the University of Texas MD Anderson Cancer Center; Royal Brompton and Harefield Hospital in London; and the Saccomanno Research Institute at St. Mary's Hospital & Medical Center in Grand Junction, Colo., Kennedy said.
The study is being led by Queen’s University Belfast medical oncologist Dean Fennell, and the team will analyze more than 1,500 non-small cell lung cancer tumor samples using Almac’s Lung Cancer Disease-Specific Array platform to identify a gene-expression signature that predicts which patients will likely go on to have disease-free survival after surgery and which are at risk for relapse.
“In our experience, it is sample collection that represents the rate-limiting step in diagnostic test development.”
Kennedy said that the Lung Cancer DSA has already been tested in pilot studies using archived formalin-fixed, paraffin-embedded lung cancer samples and “has been found to consistently retrieve in excess of 70 percent of the transcriptional information available from freshly frozen tissue.” Almac is “therefore satisfied that this platform will be suitable for the development of a prognostic non-small cell lung cancer test from archived tissue.”
According to Kennedy, there are nearly 1 million cases of NSCLC diagnosed internationally every year, presenting a “huge market” for diagnostic tests for the indication.
“In this study we are developing a prognostic test for patients with early-stage lung cancer who have had surgery,” he said. “Those with a high risk of recurrence could benefit from adjuvant chemotherapy whereas those with a low risk of recurrence should have surgery alone. At present there are no tests to help the clinician decide who should receive adjuvant chemotherapy, and who should have only surgery. This means the majority of patients receive toxic chemotherapy following surgery with no clear benefit.”
Kennedy said that the lung cancer study needs to be large, as Almac’s pilot studies have suggested that non-small cell lung cancer contains several distinct molecular subgroups.
“Essentially these sub-groups behave as different diseases with different biological characteristics,” he said. “We need to have large numbers of samples to ensure that each group is adequately represented in the test-generation phase of the study.”
One advantage that Almac has in the market is that its DSAs are designed to work with formalin-fixed, paraffin-embedded samples. Kennedy said that this has been an obstacle for other array-based diagnostic companies that are trying to bring tests to market.
“Our ability to work with archived FFPE tissues has clearly given us an advantage, as we can access huge numbers of samples both for test generation and subsequent regulatory validation,” Kennedy said. “It would not be possible to develop this type of prognostic test if we were to rely on freshly collected tumor tissue. In our experience, it is sample collection that represents the rate-limiting step in diagnostic test development.”
Another advantage for the firm is that it believes it has already established a route to clearance for its colorectal test that its lung cancer assay can follow. “We have gained considerable experience in the process of test development from the colorectal cancer test development program,” he pointed out. “Many of the infrastructural requirements for FDA approval are already in place.”
The bulk of Almac Diagnostics’ employees are split between the company’s site in Belfast and an office in Durham, NC. However, the company also benefits from its relationships with other Almac divisions, such as Almac Discovery, launched in June, which focuses exclusively on developing approaches to treat cancer and associated conditions, with the goal of developing biomarkers or diagnostics in parallel with new therapeutics (see BAN 6/17/2008).
Last month, Almac Group broke ground on a new $79 million, 240,000-square-foot headquarters campus in the Philadelphia suburb of Harleysville within Lower Salford Township.
The project, set to be completed in 2010, will allow Almac to add 265 staffers to its 495 current employees. They will relocate to the new HQ from facilities in Yardley, Pa., where Almac group now maintains its clinical technologies divisions; and Audubon, Pa., where the company has its sciences and part of its clinical services divisions.
The company does not yet have plans to relocate its diagnostics division to the Harleysville campus, though it may in time, according a statement. Still, Kennedy said that Almac Diagnostics has benefited from the recent expansion.
“One of the major strengths of the current [lung cancer] study is the number of international researchers who have approached us to take part because of Almac's global presence,” he said. “There is a belief in the Lung Cancer Research Community that Almac is one of the few companies in a position to deliver this type of clinical test to an international market.”