832-497-2220 [email protected]
In Vitro Diagnostics

Session Background

The global market of the IVD industry is expected to grow from USD$ 49.4 billion in 2016 to USD$ 69.6 billion in 2022. With a compound annual growth rate of 5.9%., it will become the largest-scale and second-fastest-growing subfield in the medical device industry. According to the statistics from the Blue Book of China’s Medical Devices (2015-2019), China’s IVD industry continues to rise with USD$ 8.6 billionin 2018 and 9.7 billion in 2019, not to mention that China’s in-vitro diagnostic reagent industry has flourished in recent years, due to the increase of medical security investment and household consumption levels,.

Take the booming China market as an opportunity, “MyBioGate Global Challenge-IVD Session” is calling all the innovative projects and teams around the world to join the competition. We will assist to partner qualified projects with Chinese industrial parks, investment institutions, and enterprises through project screening, roadshow, and cross-border accelerator, and finally reach the cooperation and realize the project landing.

Submitted Projects:

Project ID: IVD101

Category: In Vitro Diagnostics

Keyword: Coronavirus Fast Test Kit
Project/Product Summary:
Detection of 2019-nCoV, SARS-CoV and bat SARS-like coronaviruses within 20 mins in a POC setup using sputum or saliva. Our FDA cleared product and platform could be modified to detect all three strains simultaneously.

Indications: SARS and other coronaviruses

Stage: FDA Cleared, CE Marked

Partnering Objectives: Fundraising, Business cooperation

Country: USA

Project ID: IVD102

Category: In Vitro Diagnostics

Keyword: Respiratory tract infection

Project/Product Summary:

The goal of Project IVD102 is to develop a detection and identification system for corona viruses including the 2019-nCoV Acute Respiratory Disease and respective influence viruses as a point-of-care device allowing a sample-to-answer operation. This aim will be addresses with a lab-on-a-chip approach consisting of the “Chip” as a consumable and the instrument to run and control the chip. Operation of the system will work as following: After sample introduction on the chip and insertion in the respective instrument, the sequence carried out in the lab-on-a-chip system without any further manual interaction comprise: Sample enrichment, lysis, target concentration, multiplexed quantitative amplification and detection.
The project will deliver a point-of-care diagnostic platform for the simultaneous detection of the 2019-nCoV and further RNA viruses causing similar symptoms, without the need for equipped laboratory infrastructures or trained users, and a rapid turnaround time of 90 minutes from sample-to-answer allowing for 150 parallel amplifications. The system will be validated and will reach TRL 9 at the project end.

Indications: Respiratory infections caused by RNA virus

Stage: Technology Platform

Partnering Objectives: Business cooperation

Country: USA

Project ID: IVD103

Category: In Vitro Diagnostics

Keyword: CRISPR-based detection kit

Project/Product Summary:

Project IVD103 has developed a portable CRISPR-based kit for molecular diagnostics of COVID-19 (powered by novel/enhanced Cas enzymes). The company has been developing its technology as a platform, being capable of easily readapting to new targets. Recently, since the emergence of COVID-19 the team has developed a CRISPR complex (Cas enzyme + COVID-19 complementary RNA Guide), and validated it’s performance using synthetic targets and a synthetic sample of sputum (as a proof of principle of real patient sample). Caspr’s lateral flow-based test enables detection in less than 60 minutes, with minimal sample preparation.
Previously, company has been working with Hospitals & Labs in validations concerning detection limits(reaching attomolar levels) and performance of targets corresponding to different Infectious Diseases (DENV, HANTAV, ZIKA, amongst others).
Project is looking for opportunities of working with global health institutions and governments in order to further validate the aforementioned portable kit with real samples and try to scale it to production phase as soon as possible. Initial connections have been established with officials that correspond to the government of Philippines and China.
Current detection tests of COVID-19 show drawbacks when providing people and professionals with the relevant and precise information in time critical conditions. Decentralized testing is only based on symptoms assessment (temperature measurement, CT scans), thus leading to a high rate of false negatives. This is particularly relevant taking into account that incubation period has been estimated to be of up to 24 days. Hence COVID-19 spreading might occur before symptoms appear. Molecular tests (qPCR) are limited to lab settings, taking days YO PONDRIA SEVERAL HOURS ACA for results to be available and being performed in a centralized manner. Our fast, precise & portable Molecular detection solution could be crucial in better controlling and managing COVID-19.

Indications: Not applicable

Stage: Prototype

Partnering Objectives: Fundraising 3 million US dollars, Co-development

Country: USA, Argentina

Potential Chinese Partners: