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.

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.