CGI expands offerings with ExpandDx
The collaborative program uses Ventana digital pathology technology to enable partnering with CGI through remote consultations
Register for free to listen to this article
Listen with Speechify
0:00
5:00
RUTHERFORD, N.J.—Cancer Genetics Inc. (CGI) has launched its new collaborative testing program, ExpandDx, which uses Ventana digital pathology technology from Roche to enable community-based hospitals and pathology labs to partner with CGI through remote consultations and gain access to a broader range of tests. This technical-only testing service provides these hospitals and labs with the most advanced testing technologies available in addition to supporting more collaboration on atypical and difficult cancer cases.
"We’re extremely pleased to have finalized the submission of the VENTANA ALK (D5F3) CDx Assay,” said Troy Quander, vice president of Regulatory Affairs at Ventana Medical Systems, Inc. “PMA is the most stringent type of device marketing application required by the FDA. Our 4-step modular submission process for premarket approval is a major progression as it has enabled the FDA to review each module after submission and provide us with timely feedback. This helps mitigate potential delays early in the review process and ensures a more efficient and effective approval process."
"As care centers and clinicians look for ways to improve cost efficiency, technical-only testing offers opportunity for providers to more actively collaborate in the diagnosis process and manage costs for patients," Dr. Lan Wang, nedical director at Cancer Genetics, commented in a statement. "CGI's ExpandDx technical-only testing will ensure that community-based hospitals and pathology labs have access to the same cutting-edge oncology testing available at larger centers, and will allow the clinical community to collaborate on difficult cases."
Through the company's ExpandDx collaborative testing program, the technical components will be performed at CGI's labs, and clinicians will be offered the chance of interpreting and signing out their patients' test results; signing out cases remotely and sharing such cases with other team members will allow smaller labs to manage their resources while leveraging the potential of CGI's tests.
"We are very excited to partner with Cancer Genetics to provide comprehensive digital pathology solutions through their ExpandDx testing program," Rod Cotton, senior vice president at Roche Diagnostics Corporation, said in a press release. "This new service is an example of their innovation and leadership in the field of cancer diagnostics. It will enable a more collaborative and responsive diagnosis process for community-based pathologists and help them fulfill their mission to empower personalized cancer treatment."
Ventana announced progress of its own as well, noting that it had made its U.S. Food and Drug Administration (FDA) submission for premarket approval of the VENTANA ALK (D5F3) CDx Assay, a companion diagnostic immunohistochemistry test designed to identify ALK-positive lung cancer patients that could benefit from treatment with targeted therapies that inhibit the ALK gene. This submission is the fourth and final module and application that the FDA required for the premarket approval process.
"We’re extremely pleased to have finalized the submission of the VENTANA ALK (D5F3) CDx Assay,” said Troy Quander, vice president of Regulatory Affairs at Ventana Medical Systems, Inc. “PMA is the most stringent type of device marketing application required by the FDA. Our 4-step modular submission process for premarket approval is a major progression as it has enabled the FDA to review each module after submission and provide us with timely feedback. This helps mitigate potential delays early in the review process and ensures a more efficient and effective approval process."
SOURCE: CGI press release
