Frequently asked questions and further insight into Acuamark Diagnostics' technology and practices

 

Q: DOES EARLY DETECTION OF CANCER FROM A BLOOD SAMPLE HELP INCREASE SURVIVAL AND CURE RATES?

 

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%.

Depending on how completely our highly accurate screening test is adapted by the public, it would allow for about a 35% to 55% reduction of colorectal cancer deaths, and would save over $30 billion in healthcare costs per year in the US alone.


Q: WHY IS Acuamark Diagnostics STARTING WITH A TEST FOR EARLY COLON CANCER?

 

The founding scientists have a deep understanding of the colon cancer field, and have developed some of the initial molecular databases, as well as discovered and developed diagnostic tests for some of the key colon cancer genes. 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

Acuamark Diagnostics blood screen is that it identifies the very individuals who would most benefit from a colonoscopy at the earliest stage. 

In parallel to our colorectal cancer screening test, we are developing a pan-cancer screening test, which will reliably detect the majority of major cancers at the earliest stages. 


Q: BESIDES EARLY DETECTION OF COLORECTAL CANCER, WILL Acuamark Diagnostics DEVELOP TESTS FOR OTHER CANCERS SUCH AS OVARIAN, PANCREATIC, GASTRIC, PROSTRATE, AND LUNG CANCER?

 

Yes. The fundamental technology will 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 they ultimately may enable our team to develop the Eagle i5 and Eagle iSeq technology into a pan-oncology blood-based test for early 

detection of colorectal, stomach, pancreatic, liver, esophageal, breast, ovarian, cervical, uterine, bladder, kidney, prostate testicular, lung, head and neck cancers, glioblastoma and other brain cancers, thyroid and neuroendocrine cancers, melanomas (skin), sarcomas, leukemias and lymphomas.


Q: WILL Acuamark Diagnostics' BLOOD TEST FOR THE EARLY DETECTION OF CANCER REPLACE EXISTING, HOSPITAL-BASED DIAGNOSTIC PROCEDURES SUCH AS E.G. COLONOSCOPIES (FOR COLORECTAL CANCER) AND IMAGING EXAMS?

 

Acuamark Diagnostics' technology is designed to detect cancer in its early stages from blood. Our blood test is an early warning signal, or 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 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 such as imaging unnecessarily. But, if the test reports “Presumptive Positive”, then further standard diagnostic workup (e.g. advanced diagnostics such as imaging etc.), would still be necessary to verify and confirm the presence and location of the cancer. 


Q: I COME FROM A FAMILY WITH A HISTORY OF CANCER. IS THE Acuamark Diagnostics TEST RIGHT FOR ME?

 

Yes, the Acuamark Diagnostics test is designed to find early cancer both in individuals with a family history (i.e. inherited cancer), 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. In addition, any individual with a family history of specific cancers (breast, colon, esophagus, liver, etc.) should consider being tested for inherited mutations. 


Q: WILL THE EAGLE I5 TEST ENABLE DETECTION OF ADVANCED ADENOMAS?

 

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 cost-effective, 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.


Q: HOW DO YOU DIFFERENTIATE FROM SOME OF THE OTHER BLOOD TESTS IN DEVELOPMENT?

 

The Eagle i5 five-dimensional 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, and leads to better outcomes.


Q: HOW WILL Acuamark Diagnostics DEMONSTRATE THE CLINICAL UTILITY OF THE Acuamark Diagnostics BLOOD TEST?

 

We intend to conduct several clinical trials to support regulatory approval of our technology. Our clinical study design will be sufficiently robust to assess the clinical utility of our cancer screening blood tests.

From early on, we will work closely with the relevant regulatory authorities in order to design and conduct our validation study.


Q: HOW WILL Acuamark Diagnostics' APPROACH OVERCOME FALSE POSITIVES?

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%. Our Eagle i5 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.


Q: HOW WILL Acuamark Diagnostics' APPROACH OVERCOME FALSE NEGATIVES?

Our Eagle i5 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.


Q: HOW WILL I BE ABLE TO ACCESS AN Acuamark Diagnostics SCREENING TEST?

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. Once the results are known, your primary care physician will discuss them with you along with the other results of your annual checkup.