The diagnostics sector is one of the most rapidly growing markets in healthcare and has a particularly fast-growing molecular diagnostics segment.
The latest such offering from this market comes from DiagnoCure Oncology Laboratories (West Chester, Pennsylvania), a wholly-owned subsidiary of DiagnoCure (Quebec City). The company reported this week that it has received CLIA certification to launch its new Previstage GCCC Colorectal Cancer Staging Test.
According to DiagnoCure, it now can have its sales team actively promote the test and the company's U.S. clinical laboratory can perform it and report patient results worldwide.
"Receiving this regulatory certification is a major accomplishment in DiagnoCure's growth strategy, which will strengthen our leadership position in high-value molecular cancer diagnostics," said President/CEO John Schafer. "We can now provide clinicians and patients with a test using a technology that is 100,000-fold more sensitive than the current method of staging."
He added, "We can help answer the fundamental question that every colorectal cancer patient asks after their surgery: Am I cured or has my cancer spread?'"
DiagnoCure Oncology Laboratories will promote and offer the test directly to clinicians across the U.S. Following this summer's pre-launch marketing campaign, a number of physicians have already expressed interest in the test.
Every year in North America, 174,000 people are diagnosed with colorectal cancer, and 142,000 surgeries are performed.
Staging a patient with colorectal cancer is crucial because it determines the patient's course of treatment after the surgery. The current standard of care requires that pathologists microscopically examine a thin slice of tissue from the lymph nodes harvested during the patient's surgery to see if cancer has spread.
Currently, some 25% to 30% of patients with no pathologically-positive lymph nodes (stage I and II cancers) later develop recurrent disease, presumably through occult metastases that have escaped detection. Most of these patients do not receive additional therapies such as chemotherapy.
DiagnoCure said Previstage GCC provides clinicians with "significantly more accurate information for staging a patient with colorectal cancer that will increase their confidence in making critical treatment decisions."
Strong data supports the potential for the GCC test to improve the current staging of colorectal patients. The National Cancer Institute (Bethesda, Maryland) sponsored a five-year prospective clinical trial of GCC testing in colorectal cancer patients.
That study was completed recently and the company's collaborators at Thomas Jefferson University (Philadelphia) are presenting the results at major medical conferences throughout the year.
This test is just one of the latest products to come down the pipleline in molecular diagnostics, which is partly based on the human genome sequencing project, which was completed in 2003. By using technologies such as qRT-PCR, it is possible to extract DNA or RNA from body tissues or fluids (urine, blood, sputum, etc.) and to amplify it in order to identify the increased expression or non-expression of disease-specific genes or gene mutations.
In August, the FDA said that the Pathwork Diagnostics (Sunnyvale, California) Tissue of Origin test is the second in vitro diagnostic multivariate index assay (IVDMIA) device that it has cleared.
The first such test was MammaPrint, developed by Agendia (Amsterdam, the Netherlands). A genetic test cleared early last year, MammaPrint is used to determine the likelihood of breast cancer returning within five to 10 years after a woman's initial.
In July 2007, the FDA issued a draft guidance document to address pre-market pathways and post-market requirements for IVDMIAs. IVDMIA tests combine the values of multiple variables to yield a single, patient-specific result.
DiagnoCure is focused on commercializing cancer diagnostic tests and delivering laboratory services that increase clinician and patient confidence in making critical treatment decisions.