FAQs About AcuamarkDx
Precise early detection of cancer can significantly improve cure and survival rates. It identifies the growth before cancer cells become more aggressive and the tumor mass grows, spreads uncontrollably or metastasizes throughout the body.
The ability to detect molecular markers in the blood provides hope that cancers could be eradicated earlier. For instance, for colorectal cancer, early cancer survival rates are higher than 90% (stage 1), but when discovered too late (stage 4), survival rates plummet to less than 10%. Currently, over 60% of cancers are detected at stage 3 or later, and in the aggregate, the average survival of cancer patients is 50%. With reliable and accessible stage 1 and 2 cancer detection, average cancer survival rates could be increased to 70-90%.
In an ideal scenario, widespread adoption of a precise and affordable screening test by the medical community and the public could significantly decrease cancer-related deaths, by between 35% and 55%. This, in turn, could result in a corresponding reduction in the economic and healthcare costs associated with cancer, potentially lowering expenses by 50% to 75%.
Acuamark’s fundamental technology is anticipated to identify any cancer at all stages, including initial stages. The Acuamark Diagnostics team has developed proprietary methods and identified proprietary markers to cover an “all-cancer” (or “pan-cancer” or “pan-oncology”) early-detection screening test, which will ultimately be able to detect most cancers early from a routine blood sample. The assays cover a wide range of cancers, including colorectal, stomach, pancreatic, liver, esophageal, breast, ovarian, cervical, uterine, bladder, kidney, prostate, testicular, lung, head and neck, thyroid and neuroendocrine cancers, melanomas (skin), sarcomas, leukemias and lymphomas.
In the early detection segment, AcuamarkDx is concurrently working on the development of two tests. The first test, the colorectal cancer (CRC) early detection test, aims to accurately identify CRC at its earliest stages. The second test, the pan-cancer early detection test, is designed to reliably detect a wide range of cancers, including those in their initial stages. The CRC test is expected to reach the market first, followed by the more elaborate pan-cancer early detection test. Such a test is anticipated to compete with the Cologuard® stool test since most patients loathe providing stool samples.
For an early detection test in CRC, a positive result leads to a clear, actionable event (i.e., the patient goes for a colonoscopy). Several studies have demonstrated colonoscopy's effectiveness in detecting early-stage cancers and ultimately saving lives.
By comparison, the Cologuard® stool test excludes explicitly those individuals with a family history of CRC, inflammatory bowel disease or hemorrhoids. The advantage of the AcuamarkDx CRC blood screen is that it works for all patients and identifies the individuals who would most benefit from a colonoscopy at the earliest stage.
Routine monitoring is the standard of primary care for many diseases such as heart disease and diabetes. Why not for cancer? Acuamark Diagnostics' technology is designed to routinely screen for cancer via blood. Our blood test is intended as an early alert or warning signal – the equivalent of the “canary in the coal mine.” The goal is to accurately identify potential cancer early-on through a non-invasive and inexpensive screening method that is easily and routinely accessible to all (e.g., during an annual check-up at your general practitioner's practice, at retail clinics, etc.), thereby avoiding cancers being detected only at advanced or terminal stages when severe symptoms have already manifested.
Accurate screening tests for early-stage cancer will limit the chances that an individual undergoes unnecessary advanced and expensive diagnostic procedures (e.g., imaging). Only if the test returns a positive result will the patient be suggested to undergo additional standard diagnostic procedures (e.g., advanced imaging) to verify and confirm the presence and location of the cancer.
Yes, the Acuamark Diagnostics test is designed to find early cancer in individuals with a family history (i.e., inherited cancer) or genetic predisposition, and in those with no apparent risk factors, across all racial backgrounds. In contrast, the Cologuard® test excludes individuals with a family history of colorectal cancer. Acuamark Diagnostics' initial CRC screening test will be recommended annually for those at increased risk for inherited cancer and every two years for those without risk factors. Anyone with a family history of specific cancers (breast, colon, esophagus, liver, etc.) should consider being tested for inherited mutations, and proactive monitoring and increased surveillance are highly recommended.
AcuamarkDx’s goal from the start has been to build a simple, convenient, cost-effective, but accurate routine gating test for blood-based early-cancer screening.
Our approach and assays represent a stark departure – and are entirely independent – from other approaches. Other approaches rely on time-consuming and expensive sequencing. The novel assays we have built are designed to achieve superior technical product features, scalability and cost-effectiveness while utilizing commonly available high-throughput quantitative PCR (qPCR) and digital PCR (dPCR) lab instruments.
Our approach lets us see further and deeper in the blood with higher accuracy, higher scalability and lower cost. Our proprietary approach will allow us to identify the cancer tissue of origin and distinguish benign lesions from early stages of an aggressive cancer, in which high surveillance or prompt treatment is desired. This innovative approach leads to higher clinical utility, better outcomes and more savings for healthcare systems around the globe.
We intend to conduct several clinical trials to support regulatory approval of our technology, working closely with regulatory authorities and reimbursement agencies to design and conduct validation studies. Our clinical study design will be sufficiently robust to assess the clinical utility of our cancer screening blood tests.
Most current tests are based on one or a few markers, but normal variation in the human population leads to high rates of false-positive results – as high as 14% to 19%. Other approaches cover overly extensive marker testing and analysis but face confounding signals from naturally occurring biological processes such as aging.
Our assays look at many markers in a “2-dimensional” manner to provide a highly accurate and quantitative measure. We then use our machine learning (ML) algorithms to identify those individuals most likely to have a hidden cancer. Our ability to detect cancer at the single molecule level with internal proofreading enables unprecedented accuracy.
Our innovative assays can already detect cancer markers at the single-molecule level. As a tumor grows, it sends out more cancer molecules and signals into the bloodstream. Our approach is estimated to identify most of the earliest (stage 1) tumors. By performing the test every year, even if an early stage 1 tumor is missed, chances are extremely high it will be detected in follow-up screening as a late stage 2 or early (and still curable) stage 2 cancer. The emphasis is that early detection leads to a higher survival rate.
We anticipate that the Acuamark Diagnostics screening tests will require collection of 1-2 tubes of blood. Once Acuamark Diagnostics' tests are available, your primary care practitioner or a retail clinic of preference will draw blood for cancer screening and samples for the other tests associated with your annual check-up and ship them to a clinical lab.
AcuamarkDx's powerful and efficient tests are designed to reliably intercept cancer at the earliest stage – and successfully treat the patient before the cancer can grow and spread. It is intended to serve anyone and everyone who falls within the screening guidelines – and those who fall outside but wish to self-pay for the test – and to be taken at least once per year as a routine check-up. By undergoing early detection screenings, you can anticipate that if a potential cancer signal is caught and further confirmed through advanced diagnostic procedures like imaging and sequencing, cancer will typically be highly treatable, resulting in minimal suffering, anxiety, cost and disruption to you and your family.
Once the results are known, your primary care physician will discuss them with you along with your other annual check-up results. Results of this reliable routine testing method will return negative in most asymptomatic cases.
AcuamarkDx's inventions enable, for the first time, easy, robust, and accurate sampling of broad methylation markers from blood at a mid-level range. The AcuamarkDx team is currently advancing the development of its CRC recurrence panels. Looking ahead, AcuamarkDx is meticulously exploring other disease areas where (A) this method of methylation signal detection is anticipated to be relevant, and (B) where early disease detection could significantly influence the course of the disease, either by halting its growth early or by enabling curative treatment through earlier detection.