Customer Insights Lead Cofactor to Pursue Reimbursement
Cofactor Genomics’ COO, Dave Messina, is featured in this week’s Q&A. He provides answers to difficult questions including why Cofactor decided to attain CAP accreditation and shares new developments in diagnostic reimbursement that he is excited about. You can also watch the videos here.
Q: Why did Cofactor decide to pursue CAP accreditation?
A: Cofactor pursued CAP accreditation because that’s what our customers were asking for. We’ve increasingly worked with the clinical side of pharma, clinical researchers, and clinicians. We wanted to be able to process human samples and use the outcomes for clinical decision making, so clinical accreditation was necessary. We chose the College of American Pathologists accreditation rather than just the standard CLIA accreditation because CAP is widely considered to be the gold standard for clinical labs. We wanted to provide that level of assurance, confidence, and rigor for assays and for our customers.
Q: What assays are on Cofactor’s test menu?
A: We have two assays on our clinical test menu. The first is clinical RNA-seq, and we were one of the first labs in the country to offer this around 2015. It’s a really great option for those who either need a higher level of rigorous reporting or who are using RNA-seq in clinical trials or clinical decision making. The other assay on our menu is ImmunoPrism™, which is an immune profiling assay. If you’re trying to better understand what’s going on inside the tumor microenvironment and what the immune cells are doing, ImmunoPrism™ is an excellent solution.
One application is if you’re trying to understand if the immune cells are invading a tumor, maybe after treatment with a drug or a drug in development. ImmunoPrism™ is much more qualitative than any other assay. Other ways of immune profiling tend to be much less qualitative or loose in the way that they try to determine whether these cells are present, giving a medium, low, or some arbitrary score. We actually give the percentage of the sample that is CD+ cells or CD8+ or T-regs. With that level of notation, you can do a much better job of comparing the immune cell percentages from sample a sample because we’re not normalizing those out like other assays. ImmunoPrism™ is actually being used in clinical settings today to try to understand how immune cells are changing in response to treatment.
Q: How does Cofactor plan to pursue reimbursement of ImmunoPrism™?
A: This is again, in response to customer demand. We are seeing a really great opportunity from our clinician collaborators to use this assay to make treatment decisions. One of the big challenges today is an understanding which patients are eligible for immunotherapies. Typically, responses to immunotherapy in most types of cancers is 20-30% for monotherapy usage. That means that 7 or 8 out of 10 people that are prescribed at immunotherapy, won’t benefit from it. We see that there’s a great need to develop a better way of predicting whether patients will respond to therapy. We’re also seeing that there is a need among our customer base for a single platform assay that can span from translational to clinical development, through clinical trials and then into the market. Having one platform that we can use across all of those areas of drug development is important, and so being able to provide that continuity is something that is important, and another reason why we are pursuing reimbursement for the ImmunoPrism™ assay.
Q: Who can access Cofactor’s ImmunoPrism™ clinical assay? Do you offer this direct to patients?
A: We get that question a lot. Today, a consumer cannot order ImmunoPrism™. This is something that will need to be ordered through a doctor. We are licensed to offer this test through physicians so that a doctor can use the information from the assay in conjunction with all the other information they have in order to make the best treatment decision. It’s a good conversation to have between you and your doctor.
Q: What is a new development in diagnostic reimbursement or approval that you’re most excited about?
A: One area in particular that I’m excited about is the continued adoption of multi-analyte and multi-dimensional diagnostic assays. Multi-analyte means that we’re looking at multiple molecules or signals and that’s going into the diagnostic. The traditional way is to just look at a single molecule or analyte. Think about having a piece of tissue on a microscope slide and staining for just one protein to try to detect it and using that as a basis for a diagnosis. That’s the way that we’ve been using diagnostics for about 100 years.
Today we have technology which allows us to access far more information far more readily. We can take multiple signals and build them into our diagnostic classifiers and into our assays. A great example is Veracyte’s Envisio assay for diagnosing idiopathic pulmonary fibrosis, which was just given a great coverage determination.
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