Accurate early detection of cancer can increase cure and survival rates because growth is detected before the cancer cells have expanded into more aggressive clones; and before the tumor mass has grown, spread out of control, and metastasized 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 I) but when discovered too late (Stage IV), 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%.
Depending on how completely our highly accurate and cost-effective screening test will be adapted by the medical community and the public, this in turn would allow for about a 35% to 55% reduction cancer deaths, and a reduction of economic and healthcare cost associate with cancer of 50% to 75%.
Acuamark’s fundamental technology is expected to work for identifying any cancers at their early stages. The Acuamark Diagnostics team believes that the efficiencies created by its proprietary methods are so powerful, that its “all-cancer” (or “pan-cancer” or “pan-oncology”) early-detection screening tests will ultimately be able to detect the majority of cancers early from a routine blood-sample. This includes early detection of 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.
AcuamarkDx is developing two tests in parallel.
One, the CRC early detection test, is for reliably detection of colorectal cancer at its earliest stages, and one, the “all-cancer” or “pan-oncology” early detection test is designed to reliably detect the majority of cancers at the earliest stages. The CRC test is expected to reach the market first, followed by the more elaborate “all-cancer” early detection test.
For an early detection test in colorectal cancer, a positive test result leads to a clear actionable event, i.e. the patient goes for a colonoscopy. Several studies have shown that colonoscopies do detect early cancers and save lives. The advantage of the AcuamarkDx CRC blood screen is that it identifies the very individuals who would most benefit from a colonoscopy at the earliest stage.
Acuamark Diagnostics' technology is designed to detect cancer in its early stages from blood. Our blood test is intended as an early alert or an early warning signal -the equivalent of the “canary in the coal mine”. The goal is to accurately identify cancer early-on through a non-invasive and inexpensive screening method that is easily and routinely accessible to all (during the annual check-up at your general practitioner’s practice, at retail clinics, etc.) and thereby avoid cancers being detected only at advanced or terminal stages, or when symptoms are already manifesting.
Accurate screening tests for early-stage cancer will limit the chances that an individual undergoes advanced and expensive diagnostic procedures (e.g imaging) unnecessarily. If however, the test is positive, it will recommend further standard diagnostic workup (e.g. advanced diagnostics such as imaging etc.), to verify and confirm the presence and location of the cancer.
Yes, the Acuamark Diagnostics test is designed to find early cancer both in individuals with a family history (i.e. inherited cancer) or genetic predisposition, as well as in those with no clear risk factors. For instance, Acuamark Diagnostics' initial test - the colorectal cancer screening test - will be recommended on an annual basis for those at increased risk for inherited cancer, whereas on a bi-annual basis 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 pro-active monitoring and increased surveillance is highly recommended.
There are many issues associated with finding small growths known as polyps and uncertainty around which might remain harmless and which may progress. Physicians and scientists in Europe and the US offer a wide range of opinions on what is in the best interest of the patient.
In short, Acuamark Diagnostics believes that what matters is a reliable, cost-effective and convenient test that has a high enough sensitivity and specificity and is done frequently enough to catch cancers at the earliest time, and when they are most treatable.
AcuamarkDx’s goal from the start has been to build a simple, convenient, cost-effective but accurate routine gating test for early-cancer blood-based screening.
Our approach and assays represent a stark departure - and are entirely independent – from other approaches. The novel assays we have built are designed to achieve superior technical product features and cost-effectiveness, while utilizing commonly available high-throughput qPCR lab instruments.
Our approach lets us see further and deeper in the blood with higher accuracy, higher scalability and at a lower cost. Our proprietary approach will allow us to identify tissue of origin and distinguish benign lesions from early stages of an aggressive cancer, in which high surveillance or even prompt treatment is desired, leading to higher clinical utility and better outcome, and more savings for healthcare systems around the globe.
We intend to conduct several clinical trials to support regulatory approval of our technology, will work closely with the regulatory authorities and reimbursement agencies to design and conduct our 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 signal from naturally occurring biological processes such as aging.
Our assays look at many markers in multiple molecular dimensions to provide a highly accurate and quantitative measure. Our ability to detect cancer at the single molecule level with internal proofreading enables an unprecedented level of accuracy.
Our innovative assays are already able to 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 I) tumors. By performing the test every year, even if an early Stage I tumor is missed, chances are extremely high it will be detected the following year as a late Stage I, or early (and still curable) Stage II cancer. Early detection. High Survival.
We anticipate that the Acuamark Diagnostics screening tests will require the drawing of 1-2 tubes of blood. Once Acuamark Diagnostics' tests are available, your primary care practitioner or retail clinic of preference will draw cancer screening blood together with samples for the other tests associated with your annual checkup, and ship them to a lab.
AcuamarkDx’s powerful and efficient tests are specifically designed to reliably intercept cancer at the earliest stage - and nip it in the bud before it can grow - in an asymptomatic population. It is intended to serve anyone and everyone who falls within the screening guidelines – and those who fall outside of that but wish to self-pay for the test - and be taken at least once per year as a routine check-up test. By conducting early detection screenings, you can expect that if an early signal is intercepted - and it is double-confirmed by a further advanced diagnostic workout such as imaging, sequencing, etc. - the cancer will in most cases be highly curable, with minimal suffering, anxiety, cost or interruption to you and your close ones.
Once the results are known, your primary care physician will discuss them with you along with the other results of your annual checkup. In the vast majority of asymptomatic cases, results of this reliable routine testing method will come back negative.