Thermo Fisher’s Oncomine assays are multi-biomarker targeted assays designed for cancer research. According to the company, the assays enable next-generation sequencing analysis of multiple biomarker types.
Now, as part of the company’s Next-Generation Sequencing Companion Dx Center of Excellence Program (COEP), LabCorp and Cancer Genetics, Inc. (CGI) will help develop Oncomine-branded solutions for clinical and biopharma applications. Additionally, the companies will be among the first to offer the tests to physicians following US Food and Drug Administration (FDA) approval.
Joydeep Goswami, president of Clinical Next-Generation Sequencing and Oncology for Thermo Fisher Scientific told us the goal of the program is to build a network of qualified laboratories in biopharma services and clinical testing to facilitate companion diagnostics development and commercialization.
“By working with large reference labs that serve as key stakeholders to help commercialize our Oncomine Dx Target Test, they also provide Thermo Fisher guidance in reimbursement, commercialization strategies and guidelines related to companion diagnostics,” said Goswami.
In order to become a preferred partner as part of the program, laboratories must meet a list of criteria, Goswami explained, including biopharma services and clinical testing capabilities, as well as next-generation sequencing and oncology expertise. The companies must also have a large footprint, high quality, and a strong reputation with pharmaceutical groups and clinicians.
“As a Center of Excellence member, they will be our preferred partner to participate in future clinical trials with Thermo Fisher and pharma partners,” Goswami explained.
Members will also have early access to Thermo Fisher’s new products for clinical and biopharma application and will work closely with the company to generate new products and drive market adoption and clinician education.
“Thermo Fisher has been a long-standing strategic partner for LabCorp, and they’ve played a key role in our success in delivering world-class diagnostics as we pursue our mission to improve health and improve lives,” Donald Von Hagen, LabCorp VP of corporate communications told us.
CGI did not respond to a request for comment.
Fuel for the companion diagnostics industry
The growth of pharmaceutical therapeutics pipeline has been fueling the companion diagnostics industry, Goswami said. “And increasingly, multiplexing technology, such as next-generation sequencing, has become the preferred platform for companion diagnostics, given the limited amount of tissue from patients and the multiple biomarkers/drugs for each indication,” he added.
According to Goswami, next generation sequencing “is now delivering the promise as a companion diagnostics platform to attract future opportunities,” with the recent FDA approval of the Oncomine Dx Target Test in June 2017.
“Companion diagnostics are an increasingly important tool to improve the delivery of care by providing the right patient with the right treatment at the right time,” added Von Hagen. “And they’re increasingly important to LabCorp.”
Also in June, LabCorp’s Covance opened a new companion diagnostics laboratory as it prepares for an increasing demand for precision medicine – a market expected to reach $112.62bn by 2025.
“Joining Thermo Fisher’s Center of Excellence program is another extension of our commitment to companion diagnostics, and it will help us to bring more effective tests and treatments to patients faster,” said Von Hagen, adding that LabCorp is focused on getting the Oncomine Dx Target Test ready to launch so the company can offer it to its customers later this year.
LabCorp is also “looking forward to exploring more options to work together with Thermo Fisher on new tests and new applications for existing tests,” he said.
CGI will begin offering the Oncomine Dx Target Test this month.