A diagnostic test from a Roswell Park Cancer Institute-affiliated company that promises personalized cancer care based on patients’ genetic information has received approval from the state Health Department.
Roswell Park subsidiary OmniSeq LLC said the department’s Clinical Laboratory Evaluation Program has approved its OmniSeq Comprehensive panel, allowing the company to make its test available to oncologists and cancer centers this week.
This is the second OmniSeq test that has received state approval since 2014. Company officials said this panel is broader in scope and has more potential applications. While OmniSeq’s first approved test, OmniSeq Target, focused on lung cancer, OmniSeq Comprehensive applies to all forms of solid tumor-based cancer, said Kristopher Johnson, the company’s marketing director.
The Health Department approval comes at a time when OmniSeq has grown to nearly 60 employees working in the Hauptman-Woodward Medical Research Institute, where the company finished moving its laboratory from Roswell Park’s Center for Personalized Medicine a few months ago.
OmniSeq is part of Roswell Park’s big bet on personalized medicine. Roswell Park invested $25 million to develop the initial OmniSeq Target test, which is tailored to the unique genetic characteristics of individual patients.
That test identifies the genetic mutations that are driving the lung cancer, and doctors can prescribe a drug tailored to the genetic makeup of the tumor in the patient’s lung.
It analyzes 23 genes, but the new OmniSeq Comprehensive diagnostic panel analyzes 144 genes. OmniSeq Comprehensive also requires a very small sample size to generate conclusive results – about one-tenth of the typical industry requirement, according to OmniSeq. Oncologists would collect samples from their patients, ship them to OmniSeq’s laboratory, have the testing performed and await the results, Johnson said.
“This panel enables physicians to zero in on the most important results for patient outcomes,” Dr. Carl Morrison, president and chief scientific officer of OmniSeq and executive director of the Center for Personalized Medicine, said in a statement announcing the approval.
The Health Department action serves as an unofficial seal of approval for the company’s testing standards, but there are other companies and research institutions pursuing targeted genetic therapy.
It’s unclear how well the therapy will work, or how much it will cost, and insurers still must be persuaded to cover the treatment. However, Roswell Park and OmniSeq officials say they are excited about the therapy’s potential.
OmniSeq also said it is forming a partnership with Cure Forward, a Cambridge, Mass., company, to help cancer patients stay better engaged in their care and recruit them for clinical trials. Patients will be able to get their OmniSeq Comprehensive test results online and use that information to learn more about their disease and treatment options, according to the company.
And sponsors of clinical trials can use Cure Forward’s platform to identify patients who match their selection criteria and invite them to apply to participate in their studies.