IF THE NEW BUSINESS AGREEMENT between Ventana Medical Systems, Inc. and TriPath Imaging, Inc. is successful, then the anatomic pathology laboratory may have a very different look in future years.
Last week, Ventana Medical Systems, Inc. announced a five-year global supply agreement with TriPath Imaging, Inc. that involves two primary objectives. First, Ventana will put its brand on a version of TriPath’s interactive histology imaging system and sell it worldwide. Second, this instrument system will be designed to run proprietary imaging assays produced by both Ventana and TriPath. TriPath Imaging will seek 510K clearance from the FDA for performance of the Ventana assays on the interactive imaging system prior to its launch in the U.S.
New Tools For Pathologists
THE DARK REPORT believes this collaboration has the potential to produce an integrated technology platform that gives pathologists a host of new diagnostic capabilities. It is the intent of both companies to provide pathologists with a way to complement cell morphology with molecular technology.
“We believe Ventana has long viewed imaging as part of the ‘total solution’ for the AP lab,” stated Paul Sohmer, M.D., President and CEO of TriPath. “A key part of its long-term business strategy is to compliment its staining solutions with an effective imaging solution.
“For TriPath Imaging, the Ventana agreement brings us two direct benefits,” explained Sohmer. “One, Ventana has the largest sales force in both the United States and the world calling on anatomic pathology laboratories. It is the goal of both companies to leverage this resource to place these imaging systems in laboratories throughout the world. That gives both Ventana and TriPath an installed base of instrument systems which can run new molecular assays as they are developed by both our companies.
“Two, rapid advances in genomics and proteomics are creating a new challenge for pathologists. In order for a pathologist to extract and deliver the full depth of information possible to a clinician, he/she must have a way to correlate cell morphology studies with the growing number of molecular assays relevant to that particular case,” he noted.
“Combining Ventana’s stainers with TriPath’s imagers allows us to provide pathologists with a way to make that correlation,” said Sohmer. “This need already exists for ER, PR, and Her2Neu testing, for example.”
“It is being developed as an interactive system,” noted Sohmer. “The pathologist must guide the system and the supporting technology to the clinical answer. It is also ‘real time.’ As the pathologist evaluates different areas of the specimen on the screen, alongside the image will be the data, including histograms and similar results.”
Sohmer revealed that a molecular cytopathology system is under development. “In contrast to histopathology, which needs to analyze and correlate a variety of supporting technologies, our molecular cytopathology imaging station is designed to increase productivity. Our molecular assay for cervical cancer, for example, will be developed to be used with and without an imaging device. It will complement our FocalPoint™ slide profiler, a screening system for cervical cytology,” he said. “Technology used in both the histopathology and molecular cytopathology systems is very similar.”
For TriPath Imaging, the Ventana agreement has at least three strategic business benefits. “This expands our presence into an entirely new segment of the clinical market,” explained Sohmer. “We will have a place in the anatomic pathology (AP) lab, just as we now have a place in the cytology lab.
“Next, this agreement provides TriPath with an opportunity to generate new revenue streams directly from the fee-for-service instrument placements sold to Ventana,” he continued. “As these instruments come into clinical use, it then supports the sale of proprietary assays developed by Ventana and TriPath.”
Two Molecular Assays
Sohmer noted that, in August, TriPath released two new molecular Research Use Only (RUO) products to select research centers for cancers of the cervix and breast. “These assays are available for research,” he said. “We expect to begin clinical studies early next year and file with the FDA for approval in late 2005.”
THE DARK REPORT considers the Ventana/TriPath collaboration to be a significant event. It should lead to an integrated system of specimen processing and specimen diagnosis in the anatomic pathology laboratory.
Of equal significance, these products are designed to support molecular diagnostic technologies as they evolve. The profession of anatomic pathology is at the earliest stages of a clinical evolution. Cell morphology as the primary source of AP knowledge is increasingly being supplemented by molecular (genomic/proteomic) analysis.
At some point, advances in molecular diagnostics may cause it not to supplement cell morphology, but to supplant it as the primary source of diagnostic information.
TriPath, Digene File HPV Docs with FDA
Even as Tripath Imaging announced its agreement with Ventana Medical Systems, it was taking steps to advance its liquid preparation Pap smear product.
On August 26, 2004, TriPath filed supplemental data with the Food and Drug Administration (FDA) to allow TriPath’s SurePath™ Test Pack as the specimen-collection medium for Digene Corporation’s hc2 High-Risk HPV DNA Test™. Both companies want FDA approval to use their products in this complementary fashion.
Just last Thursday,Digene Corporation disclosed it had filed its own premarket approval (PMA) supplement application with the FDA to allow use of TriPath’s SurePath™ Test Pack as the specimen-collection medium for Digene’s hc2 High-Risk HPV DNA Test™.
Typically, the FDA has 180 days to issue a ruling on these types of applications. For that reason, a decision on these PMA requests is not expected until the first half of 2005.