Introduction

The CD-Box is a ground-breaking diagnostic kit created to offer quick, low-cost, and portable early detection of chronic obstructive pulmonary disease (COPD) through miRNA testing. Existing diagnostic methods, such as spirometry, were ineffective, and a more compelling strategy, RT-PCR diagnosis, is costly, time-consuming, and requires laboratory testing. As a result of this deficiency, only 2.6% of the prevalent COPD population was aware of their condition. (Koch et al., 2019)

The CD-Box (COPD Detection Box) from HS-China contributes to the status quo. Our goal became microRNA (miRNA), a small, non-coding RNA molecule found in blood that regulates gene expression. To detect hidden early asymptomatic stages before severe progressions, we used miRNA profiling, a molecular biology technique that measures and analyzes the expression levels of miRNAs in biological samples. The one-pot EXTRA-CRISPR miRNA assay, which uses labeled DNA probes or reporters to amplify the target miRNA, was used to indicate the presence and quantity of the miRNAs associated with COPD, and thus tell the stage of COPD.

Given the unavailability of spirometry, one of the current early diagnosis methods, in rural areas of low- and middle-income countries (National Library of Medicine), the CD-Box was designed to be simple to use and portable. Even non-professionals can access their lung health situation via CD-Box, and with low reagent and analytical hardware costs, the price is affordable globally.

dditionally, CD-Box served as a source of inspiration for additional study in the area of miRNA-based early disease detection and contributed by offering itself as a potential large database for the diagnosis of respiratory diseases. Our business operation is consisted of parts shown in mind map below:

Business Operation

Market Analysis

i. Introduction:

Chronic Obstructive Pulmonary Disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Early detection and management of COPD can slow the progression of the disease and improve quality of life. Hence, there's a significant market for COPD detection.

ii. Market Size:

The global COPD detection market is expanding due to the rise in the prevalence of the disease. As of Precedence Research, the COPD detection market reached USD 18.1 billion and is expected to grow at a CAGR of 5.14% over the next ten years. Figure 2 below demonstrates the worldwide prevalence of COPD in 2022.

iii. Competitive Landscape:

The market is dominated by major players like BMC Medical Co., Ltd., Molecular Assembles, and Qiagen, and Figure 3 below demonstrates main competitors following their products.

The market is dominated by major players like BMC Medical Co., Ltd., Molecular Assembles, and Qiagen, and Figure 3 below demonstrates the main competitors following their products.

BMC Medical Co., Ltd. focuses on equipment, such as spirometry, dealing with respiratory diseases. Molecular Assembles researches and develops qPCR equipment, while Qiagen engineers biomarker reagents.

However, spirometry requires repetition of measurement and acquires high skills from doctors, whereas qPCR and RT-PCR have high accuracy, but have strict threshold for a lab environment and equipment.

Patent

i. Intellectual Property

Patents are a type of intellectual property (IP), described by the U.S. Patent and Trademark Office as giving the owner of the patent “the right to “exclude others from making, using, offering for sale, or selling” an invention or “importing” it into the U.S.”. When filing patents, applicants must fully disclose their invention. Furthermore, the invention must fall within the confines of the patent laws.

ii. Landscape Analysis

The USPTO recommended a search for patents and prior art before actually filing for a patent. We performed a search on Google Patents, using keywords such as “miRNA”, “COPD”, “detection”, and “biomarker”. Through our search, we discovered several related patents. However, these are all fundamentally different from our project, and thus do not pose risk of patent infringement. Each is discussed below.

• The first patent “Chronic Obstructive Pulmonary Disease (COPD) Biomarkers and Uses Thereof (US9423403B2)” describes methods and kits for COPD diagnosis or risk assessment. It also assesses lung function decline. However, the assays described in the patent are obviously different from our project, since it does not involve the use of RCaa/Cas12a to detect miRNA biomarkers. Thus, this patent is unlikely to cause any infringement issues.

• The second patent “Detection and the method and Device for the Treatment of Respiratory Insufficiency (CN103989478B)” describes an invention/detection device aimed for assessing the seriousness of respiratory insufficiencies such as COPD. The invention is largely based on pressure and ventilation levels, and does not involve biochemical reactions or miRNA biomarkers. Thus it has no potential to cause infringements.

• The third patent, “Biomarkers for Systems, Methods, and Devices for Detecting and Identifying Substances in a Subject’s Breath, and Diagnosing and Treating Health Conditions (US2020337594A1)”. This patent describes biomarkers for identifying agents such as volatile gases (VGs), and for further diagnosis of lung conditions, including COPD. However, the substance detected does not involve miR-223, our selected biomarker. The systems of detection also differ. Thus there is no threat of infringement.

• The fourth patent, “miRNA Fingerprint in the Diagnosis of COPD (US9528158B2)”, while involving miR-223, only determines the specific miRNA that have altered regulation levels in disease states. It does not offer any of the advantages our system offers for COPD diagnosis. Thus, there is still next to no chance of infringement.

iii. Patenting

We have found no existing patents similar to out detection assay or analytical software/hardware. Thus, both our assay and the corresponding analytical device are patentable. Our assay would be patented as ‘miRNA Biomarker based Exponential RCA with CRISPR-Cas12a (MB-ERC2)’, while our device would be patented as ‘Visual Based Disease Detection Device (VBD3)’. We aim to file the patents within the next months, preferably with aid from our instructor’s company, which could help us save time and avoid making common mistakes.

Business Model

i. cost chart

ii. . revenue chart

The COPD market is anticipated to expand quickly, doubling in size from USD 18.1 billion in 2022 to USD 29.88 billion in 2032 (Precedence Research). In early 2024, when CD-Box applies for China Medical Device Class III certification to become officially certified diagnostic equipment, it is very likely that CD-Box will be introduced to international health organizations and families and become a big hit. After CD-Box enters the market in 2024, the estimated revenue in ten years is shown in the chart below.

iii. Future Development Plan

Conclusion

We are hopeful that our project would be successful in taking off as a start-off company. In the long-term, our detection system and device could potentially gain a wide reach, beyond our pre-selected markets of North America and Europe. We will continue to aim to reduce the cost of manufacturing and distribution, as well as spreading COPD related knowledge. In order to achieve this goal, we aim to establish collaborations with governments and hospitals. We also hope that feedback could be given by researchers and medical workers testing our device, so that we could perform modifications to further optimise our system and convenient our users. Furthermore, we hope that our work may inspire others to contribute to disease diagnosis and treatment.

Business Plan

Download our business plan below.