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.
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)
Source: January 2017 Volume 18, Issue 1, Pages e27–e34 Clinical Lung Cancer
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.
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).
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.
5% Medicare, Adverse events, Biopsy, Diagnosis, Retrospective cohort
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.
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: