CollabRx ONE is a uniquely personalized cancer research program that provides you and your physician with invaluable insight into your specific treatment options, including those not likely to otherwise be identified. Our researchers use state-of-the-art genomic technologies to extract molecular information from your biopsies, and then conduct in-depth analyses to potentially link your specific cancer to relevant therapies.

We present the full analysis to you and your doctor who may integrate these results into your treatment plan. We also provide support and follow-up through our dedicated relationship with you and your oncologist.

CollabRx ONE has developed proprietary methods to analyze your unique molecular data, starting with your tumor biopsy, and holistically assess what mechanisms may be driving your illness. We provide your physician with data to help identify therapies that may address the underlying biology of your cancer by examining the factors that appear to sustain it. Because the focus is on your tumor sample, the treatment opportunities we identify are specific to you.

The promise of personalized medicine came into focus with the sequencing of the human genome. However, it is only now with technological advances on several fronts that the field of personalized medicine is coming into its own.

A number of approaches have recently been adopted in the cancer field. These approaches all have strengths and drawbacks, and it is important to find the one that’s right for you.

Most common are approaches that test 1-2 genes to determine suitability for a particular therapy. For example, a Her2 test is usually provided before prescribing a breast cancer patient Herceptin, and a test of KRAS is usually provided before prescribing a lung or colon cancer patient Tarceva or Erbitux. The main strength of these tests is that there is an extensive amount of validation showing a relatively high response rate to the drugs if the test indicates it. The weakness is that it doesn’t shed light on how to proceed if the test does not indicate the drug.

Less common is testing via a gene panel. There are two types of approaches here. One is assembling a panel of tests, such as the Her2 and KRAS above. The strength of this is that there are a number of drugs being examined simultaneously, but the weakness is that the results can be difficult for physicians to interpret and that the scan is limited to 10-15 genes and 10-15 possible therapeutic options.

The other type of gene panel is prognostic testing, such as OncotypeDX for breast cancer. These panels give a sense of how aggressive the cancer is likely to be, which can suggest whether your physician should pursue an aggressive strategy, but does not indicate a particular personalized treatment strategy in the case that aggressive action is needed. Such guidance can be quite useful at an early stage of disease, but once the cancer is proven aggressive (e.g., metastasizing) the information is redundant.

Chemosensitivity is yet another approach that is sometimes taken. In this approach (also known as in vitro screening), your tumor cells are grown in a petri dish and 10-20 different chemotherapeutics are tested to see which cause the cells to die. Unfortunately, cells grown in a petri dish tend to behave differently from cells grown in your body (which have blood vessels and other structures to support them). Studies have shown that such assays are fairly good indicators of which therapies won’t work, but successfully killing cells in vitro has little indication of whether it will work in the patient (REF). Other issues include the fact that this method is only applicable to traditional chemotherapeutics (not modern targeted therapies) and that it requires a substantial amount fresh tissue, so a new biopsy will typically have to be done to perform these.

Xenograft models are also occasionally used. Here, tumor cells are implanted into immune-deficient mice, and allowed to grow. Then a drug of choice is given to the mice, to determine whether the cancer responds. While not fully comparable to a patient, a mouse is a closer alternative, and this approach could be used for targeted therapies as well as chemotherapy. However, it is quite expensive, and pragmatically can only be used to choose within a few drugs (such as options that might be generated by CollabRx ONE). Additionally, like chemosensitivity, it will likely require a fresh biopsy to gain the requisite tissue.

CollabRx ONE is a unique and novel approach. It is most similar to the gene panels described above, except that we are looking not just at a handful of genes but the entire genome, and can identify options among the majority of the pharmacopeia (2000+ FDA approved drugs) and investigational drugs. We do our investigation at the functional/pathway level – so rather than relying on a single data point to formulate hypotheses, we look for 10-30 pieces of evidence that converge to a single direction, and identify mechanisms that appear to be driving the cancer and drugs that are known to impact those mechanisms. Rather than just testing whether you fit a specific treatment, CollabRx ONE aims to be comprehensive – to leave no stone unturned. Beyond the specific analysis, we will partner with you and your oncologist to design/conduct studies to answer ongoing questions that may inform treatment decisions. You can consider us as your personal scientific research team, partnering with your medical team to make sure they have the most information that science can offer today in making their decisions.

There are two key downsides to this approach: it’s novel approach, meaning there is very little data to prove its utility, and it is not reimbursed by insurance carriers. (We are now collaborating with several top medical centers to design studies to provide supporting data.) It isn’t suitable for everyone, but we’d be happy to talk with you and together determine whether it is a fit, and if it is not, discuss possible alternatives such as the above that may be more suitable to your stage of disease. You should be aware that we cannot accept you as a patient unless your oncologist is supportive – while many are skeptical at first, after we have a phone call explaining what we do and answering their questions, most oncologists are excited about the analysis we can provide.

• CollabRx ONE has a dedicated research team that works on behalf of you and your doctor to identify potential treatment choices. Our program considers options from among thousands of possible therapeutic options, including those drawn from clinical trials, based on your unique cancer profile.
• We look at thousands of genes and include all the latest technologies—leaving no stone unturned.
• We update you during the research process and partner in your support throughout your illness.
• We work diligently with your physician before, during and after the process to ensure the information we provide is used most effectively, while maintaining the highest regard for your physician's expertise and the doctor-patient relationship.
• We are straightforward about the possibilities for success of this program, based on our experience and your unique variables.
• We continuously search, throughout the course of your illness, for additional approaches that may be helpful.

We are a young company, performing cutting-edge research. We cannot promise results but we do use the most promising methods available today and conduct exhaustive analysis of the data generated. We are in the process of validating the utility of our approach.

While we typically can use existing biopsies, there may be circumstances that would call for a new biopsy (such as strong evidence that the cancer has mutated).

• As soon as you are ready to move forward, we will arrange for biopsies, usually from already collected tumor samples or previous biopsies, to be sent to CLIA-approved laboratories that run CollabRx ONE specified tests.
• Our experts will then perform extensive genomic research and in-depth analysis of the molecular profile, in order to suggest therapy options that could address the mechanisms responsible for sustaining your illness.
• We will then present the results, and the scientific rationale, to you and your doctor. Our goal is to provide information to help you and your doctor optimize your treatment action plan with the findings from your personalized research program.

The first phase of the process culminates in a meeting between you, your oncologist(s), and our scientists, at which we present our findings. Typically discussions are about the science and the rationale we have, potential risks and benefits of the approaches we highlight, about potential studies that could be performed to further strengthen the evidence supporting a given approach. A written report summarizing our findings will also be provided. CollabRx will continue to assist you and your physician by, for example, coordinating follow-on studies, researching outstanding issues that could inform treatment decisions, etc., and essentially can function as a “research arm” to your medical team. Unless the requirements are major, this follow-on work is typically provided free of charge (aside from passing through costs we pay third parties to perform studies.)