NEW YORK, NY / ACCESSWIRE / March 21, 2019 / Q BioMed (QBIO) and its key technology partners are set to initiate development of an industry-changing diagnostic kit for monitoring glaucoma severity and progression. Pending FDA clearance, which could come sooner than many biotech investors might expect, this kit offers the potential to improve the quality of life for glaucoma sufferers by helping preserve visual function in glaucoma patients through accurate monitoring of disease progression. As a result, this diagnostic offers substantial future value to the Company.
Diagnostic Kit Offers Critical, First-of-its-Kind Functionality
Based on the novel GDF15 biomarker, this kit's core, platform technology enables more effective measurement and management of glaucoma progression and patient treatment than any current monitoring or therapeutic approaches---a tremendous advantage. Considering that no single examination or diagnostic test is able to accurately predict disease progression, QBIO's prospective offering serves an unmet need for millions of patients.
Glaucoma, which afflicts 70 million people, is diagnosed via a comprehensive eye exam, including visual field testing and tonometry, which measures pressure inside the eye as a means to determine if increased risk factors for glaucoma exist. While this may be the gold standard in intraocular therapy testing, this method is not truly counted on for diagnostic purposes as it relates to determining progression. As a result, the GDF15-based tool could emerge as the industry's diagnostic standard-bearer and early stage detector.
The Next Steps
This enabling technology will act as a companion diagnostic to the MAN-01 small molecule therapeutic with a novel mechanism of action for the treatment of Primary Open-Angle Glaucoma. The aim is to develop a simple integrated diagnostic test that can be performed at a physician's office with no external, expensive equipment.
The Biointerfaces Institute will work with Mannin Research to create, assess, and apply DNA aptamers for detecting GDF15 in aqueous humor of patients with different severities of glaucoma. The intent is to create multiple prototype assays for the detection of GDF15 which will be suitable for point-of-care testing. Thus, the prototype kits are to be validated in a clinical setting. This personalized medicine approach illustrates the underlying innovation of the platform technology whose key function is to improve disease progression measurement and patient treatment outcomes.
Interestingly, the Company has a good deal of flexibility with respect to its development process and FDA clearance pathway. It can elect to develop the kit for 510(k) FDA clearance or a PMA (Premarket Approval) designation and each pathway has its own advantages. It has been our experience that the 510(k) process tends to be faster than PMA, which means that revenue could be generated very quickly. The PMA route, while a bit longer, can sometimes provide a greater marketing and deployment boost as the underlying providers can advertise their device as PMA-approved or FDA-approved.
Major Value to Be Generated Via the QBIO Roadmap
The QBIO product roadmap provides key insight into the business model from which investors can extrapolate a future, tangible value range.
Upon clearance or approval of the diagnostic kit, Q BioMed would charge a to-be-determined fee to the ophthalmologist for each assay and analysis. Since glaucoma is a lifelong disease, these swift tests will have to be performed on a routine basis on patients to preserve visual acuity and measure progression, it renders the kit as a recurring (and compounding) revenue stream for the physician and the Company. Considering 70 million are afflicted today, and millions more could be tested for measurement and progression at earlier intervals, it is reasonable to expect that one in three patients could regularly undergo this test, generating considerable revenue.
Leveraging a novel mechanism of action, this platform technology will act as a companion diagnostic to the MAN-01 small molecule therapeutic which Q BioMed and Mannin Research Inc. are currently developing to treat Primary Open-Angle Glaucoma. By serving as a companion diagnostic to the therapeutic, the device will play the role of a bridge from diagnosis/analysis/monitoring to therapeutic treatment---which could carry a price tag far greater than that of the diagnostic kit. In essence, by capturing a meaningful share of the diagnostic market for this segment due to the one-of-a-kind properties and capabilities, the migration to the higher priced and higher profit therapeutic could be considered a slam dunk.
Enter Big Pharma
As accuracy of the GDF15 biomarker is further affirmed, it could ultimately be used as a surrogate biomarker to ocular therapy clinical trial endpoints—perhaps even used as a primary endpoint in MAN-01 trials and studies. In this scenario, major pharmaceuticals engaging in glaucoma or tangentially-related glaucoma or ocular clinical trials may elect to license the biomarker so that they may have access to it for the trials.
By leveraging a single platform, QBIO has multiple shots on goal with respect to market share, revenue and profit in the multi-billion dollar glaucoma market. A unique player on the path to offering a series of "firsts", QBIO is leading innovation in the lucrative ophthalmology segment, which carries high price/revenue multiples.
# # # #
Goldman Small Cap Research, a stock market research firm specializing in the small cap and microcap sectors, released this new Company Spotlight article on high profile biomedical company Q BioMed Inc. (QBIO). To view this article, along with previous QBIO articles, disclosures and disclaimers, or to download them in their entirety, please visit http://www.goldmanresearch.com.
In this Goldman Small Cap Research Company Spotlight article, analyst Rob Goldman features an analysis of recent events and his take on the future impact it will have on Q BioMed.
About Goldman Small Cap Research: Founded in 2009 by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces sponsored and non-sponsored small cap and microcap stock research reports, articles, stock market blogs, and popular investment newsletters.
Goldman Small Cap Research is not in any way affiliated with Goldman Sachs & Co.
This press release contains excerpts of our most recently published sponsored company spotlight article on Q Biomed Inc. The information used and statements of fact made have been obtained from sources considered reliable but we neither guarantee nor represent the completeness or accuracy. Goldman Small Cap Research relied solely upon information derived from Q Biomed Inc. authorized press releases or legal disclosures made in its filings with the U.S. Securities and Exchange Commission http://www.sec.gov.
Separate from the factual content of our article about the Company, we may from time to time include our own opinions about the Company, its business, markets and opportunities. Any opinions we may offer about the Company are solely our own, and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice. Statements herein may contain forward-looking statements and are subject to significant risks and uncertainties affecting results.
A Goldman Small Cap Research report, update, newsletter, article, trading alert, corporate profile, or press release is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed is to be used for informational purposes only. Please read all associated full disclosures, disclaimers, and analyst background on our website before investing. Neither Goldman Small Cap Research nor its parent is a registered investment adviser or broker-dealer with FINRA or any other regulatory agency. To download this article or any of our research, view our disclosures and disclaimers, or for more information, visit www.goldmanresearch.com. Goldman Small Cap Research was compensated a total of $6000 by a third party for research and distribution services for multiple articles.
For more information, please visit: www.Qbiomed.com
Goldman Small Cap Research
Rob Goldman, Analyst
SOURCE: Goldman Small Cap Research
View source version on accesswire.com: