Investment Highlights

BIOMARK INVESTMENT HIGHLIGHTS

BioMark Diagnostics Inc. is a leader in next-generation cancer diagnostics using metabolites. The Company is developing proprietary, non-invasive, highly accurate solutions to cost-effectively detect cancer in its very early stages, when most cancers can be cured. BioMark is also developing diagnostics that can be used to increase the uptake of lung cancer screening using Low Dose CT, measuring a patient’s response to treatment and for the ongoing monitoring of cancer survivors. The Company’s initial focus beyond a general cancer red alert tool is on diagnostics for lung cancer, with plans to expand into breast, pancreatic, thyroid and glioblastoma cancers.

Investment Highlights CSE Symbol BUX • FSE Symbol: 20B • OTCMKTS Symbol: BMKDF

BioMark™ Value

BioMark-Investor-Relations

Target Market Focus For The Current Assays

 

Use SSAT1 Red Alert – General low-cost test for high risk individuals during routine test in cancers that have been associated with high levels of this enzyme. Lung, breast, prostate, thyroid and glioblastoma. The same assay can be utilized to measure response following treatment and to monitor for recurrence once baselines are established in the cancer survivor population group

Lung Cancer Metabolite Panel – Early detection of lung cancer in high risk population and to complement Low dose CT screening for lung cancer.
Below is an abstract* that provides a potential market impact of our diagnostic test success for this application. (BioMark’s assay advantages include low cost, minimally invasive, low false positives and leverages existing lab infrastructure)

* Abstract:
Source: January 2017 Volume 18, Issue 1, Pages e27–e34 Clinical Lung Cancer

Purpose

To assess the diagnostic costs leading up to a lung cancer diagnosis in patients with abnormal computed tomography (CT) scans.

Patients and Methods

A retrospective cohort study using the 5% Medicare claims data (January 1, 2009, to December 31, 2011) was conducted. Patients aged 65 to 74 years with an abnormal chest CT scan were identified. Index was defined as the date of the abnormal chest CT scan. Outcomes assessed over a 12-month follow-up after index included lung cancer diagnosis rate and the use and associated costs of follow-up diagnostic tests up to diagnosis of lung cancer.

Results

Of 8979 patients identified with an abnormal chest CT scan (mean age, 69.3 ± 2.9 years), 13.9% were diagnosed with lung cancer over 12 months. Chest x-rays were the most common diagnostic test. Of the 19% who underwent a biopsy, 43.6% were not diagnosed with lung cancer during follow-up. The average total diagnostic assessment cost per patient was higher for those with versus without lung cancer ($7567 vs. $3558). Among patients not diagnosed with lung cancer, the median diagnostic cost per patient for those with versus without biopsy was ∼ 28 times higher. Adverse events significantly increased the average cost per biopsy (approximately 4-fold).

Conclusion

Total lung cancer diagnostic cost was $38.3M in the defined study sample, of which 43.1% was accounted for by biopsied patients without a lung cancer diagnosis. Additional risk stratification is required to decrease unnecessary biopsy referrals and costs. Further, adverse events significantly increased costs.

Keywords:
5% Medicare, Adverse events, Biopsy, Diagnosis, Retrospective cohort

BioMark’s SSAT1 Assay

 

  • BioMark’s initial assay detects SSAT1, an enzyme with elevated levels in numerous cancers, using an FDA approved drug. The assay targets a well researched metabolic pathway. BioMark is the only company that uses a safe therapeutic agent for diagnostic indication. This assay (SSAT1) can be used as a non-invasive, cost effective red alert tool for physicians globally
  • BioMark has completed a comprehensive trial and is currently assembling a submission package to Health Canada for market approval for this test which physicians can use as a screening test and help to assess the need for more definitive imaging or molecular test. To further support the submission BioMark has 2 peer reviewed publication (PubMed) and intends to publish and present other papers throughout 2019
  • Initial focus on diagnostics for lung cancer, with plans to expand into breast, prostate, glioblastoma, pancreatic and thyroid cancers
  • BioMark is developing with its scientific team a proprietary method to dramatically reduce the cost of the test

Initial markets would include Canada and Bangladesh which has a large addressable market. The company intends to begin marketing the test after Health Canada and Bangladesh Ministry of Health approvals.

 

How We Conduct Our Test (SSAT1 Assay)
– Convenient & Non Invasive

BioMark - How We Conduct Our Test

Test Delivery Options – SSAT1 Assay

LC MS Based System – READY TO MARKET

  • ITA secured
  • SOP established
  • Reference lab/Hospital

ELISA KIT

  • Antibody generated and optimized
  • Reference lab/Hospital

POINT OF CARE

  • Antibody generated and optimized
  • Prototype is under development
  • Health Care Center/Home

New Lung Cancer Panels

BioMark Diagnostics has over the past 3 years invested and successfully developed a new high-powered metabolic panel assay that has been validated and is highly robust. This performance panel assay has clinically demonstrated superior detection capabilities for early stage 1 and 2 lung cancers using urine and serum. This is a major breakthrough in molecular cancer diagnostics and strategically positions the company in a vintage position for high risk lung cancer screening market which currently uses low dose CT scans (LDCT). BioMark’s assays have the following merits compared to existing LDCT test:

  • Is the new test more accurate? That is, can it detect disease when it is present and rule it out when it is not present?BioMark’s test is accurate and dramatically reduces false positive rates compared to LDCT (False positives rates range from 30 to 55%)

  • Is it less invasive? Is the sample required easier to obtain and/or does the procedure cause less discomfort for the patient?BioMark’s test is safe and part of standard procedure especially for high risk individuals. In addition, the test could reduce the need for biopsy and related complications
  • Is BioMark’s test faster? Does it provide results more quickly so that treatment can begin sooner?Yes within 24 hrs and can be incorporated into the workflow for the doctor easily; it can also reduce patient anxiety related to waiting time. The test will be cost effective and would allow for disadvantaged communities to have access to tests.
  • What is the current market size and uptake of LDCT lung screening for high risk individuals?There are over 7.8 million high risk individuals in USA that are eligible for an annual lung screening across USA. The current uptake is only 3.6%. BioMark’s test can be the new standard for lung cancer screening