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BioMark Diagnostics Validating Multianalyte Metabolite Panel for Lung Cancer Screening


NEW YORK ─ Liquid biopsy testing firm BioMark Diagnostics is developing a multianalyte panel to detect metabolites shed by cancer cells in the blood with an eye on commercializing a test for the early detection and screening of lung cancer.

The panel, which uses mass spectrometry to detect the presence of nine metabolites in a sample, is part of two clinical studies, one prospective and the other retrospective, whose results BioMark will use to seek approvals to run laboratory-based lung cancer screening services.

The British Colombia-based firm intends to launch a blood test that uses the metabolomic biomarkers and mass spectrometry to detect lung cancer at stages I and II when a physician's intervention can have the greatest impact, CEO Rashid Ahmed Bux said in an interview.

"Doctors need more and better options to detect lung cancer as early as stage I when survival rates are between 85 and 95 percent," he said, adding that a low-cost, high-throughput metabolomic test has the potential to make early-stage lung cancer screening feasible and affordable globally.

Metabolic fingerprints can be used to determine the stage and location of a carcinoma in a noninvasive manner and allow for the distinction between metabolic processes in healthy cells as well as cancer cells, he added.

BioMark expects to see results from the current studies in 12 to 18 months and then seek approvals to run tests from laboratories in the US and Canada, Bux said.

In the clinical studies, the firm is targeting performance for its metabolite-based panel that is equivalent to that of its biomarker discovery and validation study published in Cancers in 2020, in which the panel demonstrated an area under the curve greater than 0.9.

The 2020 study included plasma samples from 156 patients with biopsy-confirmed non-small cell lung cancer as well as samples from 60 healthy controls.

In it, the investigators conducted a quantitative analysis of 138 metabolites in all samples using mass spectrometry and narrowed that down to a panel of nine biomarkers for detecting early stage (I/II) NSCLC in plasma.

In mid-February, BioMark will kick off the prospective study to further validate the metabolite biomarkers in combination with genomic and radiomic biomarkers. The firm said it is adding the genomic and radiomic markers to further boost the performance of the assay in clinical settings.

Investigators in eight Quebec hospitals are recruiting 4,000 patients at risk of lung cancer to validate the multiomics panel, as part of a collaboration involving AstraZeneca, Pfizer Canada, and the Quebec Heart and Lung Institute.

Bux said the study investigators will track the clinical progress of participants after testing and compare the performance of the new test with that of low-dose computed tomography scans.

"In prior work with BioMark, we have observed that the sensitivity and specificity of its metabolic panel is really promising," said Philippe Joubert, a thoracic pathologist at Quebec Heart and Lung Institute. Though Joubert is a clinical investigator in the current study, he is not affiliated with BioMark.

Unlike the Cancers discovery and validation study, the new study seeks to validate the performance of the assay as well as genomic and radiomic biomarkers in detecting "early-stage lung disease and distinguishing between benign and malignant nodules in a clinical screening population," Joubert said.

The investigators are recruiting patients that are 50 years of age or older and have risk factors for lung cancer development such as a smoking history.

Joubert currently uses low-dose CT scans for lung cancer screening, which he said are time-consuming and require a trained radiologist to interpret the results.

Up to 25 percent of screened patients undergoing such scans are shown to have lung nodules and may require an invasive biopsy to determine whether the nodule is benign or cancerous, he said. By showing whether such nodules are benign or cancerous using a blood draw, BioMark's assay has the potential to reduce the number of invasive biopsies and related health system costs.

The firm's second clinical study, being conducted with collaborators at the University of Alberta's Metabolomics Innovation Centre, involves a retrospective analysis of 1,200 patient samples to not only validate the performance of the metabolite biomarker panel for early lung cancer detection but also evaluate its ability to differentiate lung cancer from other medical conditions.

Bux said about 60 percent of the blood samples in the blinded, retrospective study are drawn from patients with stage I or II lung cancer, while the rest are drawn from patients with chronic obstructive pulmonary disease, emphysema, other lung conditions, or breast cancer.

Jean-François Haince, general manager and CSO of BioMark, said that if the current studies are a success, the company will seek provincial approvals in Canada to run the lung cancer screening test from its laboratory in Quebec. Meanwhile, the firm also has plans to run a laboratory-developed test for lung cancer screening from a CLIA-certified laboratory in the US. It is in discussions with AstraZeneca to jointly establish a testing laboratory and Center of Excellence in a yet-to-be-determined location in the US, Haince said, adding that AstraZeneca is interested in the potential to use the metabolite-based assays to screen patients who could benefit from current lung cancer drugs as well as drugs in development.

If BioMark obtains approval to test samples in laboratories in Canada and the US, it will apply for test reimbursement to Medicare and private payors in the US and private payors in Canada, Haince said.

He noted that companies in the liquid biopsy space are looking to detect either circulating DNA or circulating tumor cells while extracting the DNA and looking for specific tumor biomarkers. Unlike nucleic acid material which can quickly degrade, metabolites shed from cancer cells directly into the bloodstream are extremely stable, enabling BioMark's metabolic panel to be easily incorporated into current clinical workflows, he said.

Use of a metabolite panel as well as mass spec means the firm will be able to offer its test at $100 per panel, Haince added. 

BioMark began operations about 14 years ago when it licensed technology from the University of Manitoba that became the basis of its multianalyte panel. Bux said he initially invested funds to launch the company and over the years has obtained additional funding through numerous government grants. Publicly traded on the Canadian Stock Exchange for the past seven years, BioMark has also raised about US$4 million in public funding, Bux said.

Though the lung cancer screening assay may become its first commercial product, the company is developing a portfolio of products for cancer management that consists of the lung cancer screening assay, a therapeutic agent for glioblastoma, and tests to track the response to treatments for lung cancer and glioblastoma, Bux said.