Singapore-based molecular diagnostics and genomic services firm AITbiotech recently spun off a new division called AITventures to commercialize life science technology and diagnostics.
Funded with approximately S$5 million ($3.9 million) from the government of Singapore and AITbiotech, AITventures' initial seed project will be Phoenix Molecular, a company developing a hand-held, disposable, microfluidic PCR medical diagnostic device. The device consists of one-step extraction, lateral flow over printed circuits and dried reagents, and highly fluorescent beads that can be read with a simple LED, according to Phoenix Molecular CEO Eric Wilkinson. It will also be powered by a nine-volt battery and interface with a smartphone app.
The device is based on three proprietary technologies, Wilkinson told PCR Insider. The nucleic acid sample prep is designed for use with whole blood. Its extraction system is made up of layers of padding. The first pad absorbs and separates red blood cells, while the second absorbs plasma. In this layer, proprietary reagents tethered to the membrane bind nucleic acids. A third pad absorbs waste and cellular debris. Then, "nucleic acids are eluted with a drop of buffer, which initiates the PCR reaction," said Wilkinson.
The PCR element of the Phoenix device uses a lateral flow-type membrane. It is imprinted with heating elements, and all of the amplification and detection reagents are dried on the card. This offers significant advantages, according to Wilkinson. "The card acts as a disposable thermal cycler and costs very little to manufacture, [and] the dried reagents are spread evenly over the card so they are refreshed at every cycle creating greater amplification efficiency and less chance of primer dimers as well as allowing nested primers to be added in later cycles," he said.
The detection system consists of proprietary nanoparticles infused with fluorescent molecules, Wilkinson said. "We have shown the detection system to be about 1,000 times more sensitive than other fluorescent systems, with very little auto-fluorescence and little or no bleaching," he said. He added that the detection system can be visualized using a standard LED, so "no expensive optics are required."
Wilkinson said that Phoenix has one patent already issued covering "the major piece" of the technology, although he didn't specify whether it is an international, US, or other patent, and have assorted others in the review process.
Wilkinson is confident in the potential of the device. "From a strategic development standpoint this technology can open up new markets that currently do not have access to molecular testing," he said. "Currently it takes [$100] or so, a complex lab, and a few days to get an answer. We plan to release tests for as little as $5 on a device which requires little training, and results are within 10 minutes. Target markets outside of human diagnostics can include military, industrial, food processing and packaging, cruise ships and airplanes, and public health."
Wilkinson said development of industrial testing will allow Phoenix to enter the market and start generating revenues in order to complete the regulatory process for human health applications, since "the development and regulatory approval of a PCR-based [point-of-care test] is not a cakewalk."
Ultimately, Phoenix hopes to leverage the development investment from its partnership with AITventures to grow its global footprint. "Our approach is to utilize the opportunities available in Singapore to create a truly international company ... we are taking a regulatory and marketing strategy which will maximize our ability to expand beyond Southeast Asian borders," Wilkinson said.
AITventures will be headed by Joseph Lee, a life sciences and diagnostics industry specialist previously affiliated with Roche and Abbott. In an email with PCR Insider AITbiotech CEO Alex Thian said AITventures will assist its seedling companies with product development and validation studies, and will consult on regulatory strategy and market development. The company plans to cultivate about 15 technologies or partnerships "at various stages of commitment and involvement with local or foreign entities," he said.
Startups can draw on resources such as AITventure's in-house team to assist in MDx development in Singapore, ISO 13485 certified labs, and equipment for development and testing of genomics-based MDx technologies. AITventures has partnered with local and foreign multi-national corporations, so have "a global network of distributors and partners which we can provide these fledgling companies’ products for immediate access into these markets," Thian said.
AITventures also plans to help startups secure additional government grants and VC investment. For example, he said, "We are currently working together to apply for a government grant of S$500,000 for Phoenix Molecular for the development of the new products, as well as fundraising to get additional incubation funding of about S$1million. We expect these to come on stream within next three to six months."
While the company is open to overseas collaboration, Thian said most of its work will be focused on nurturing Singapore-registered startups in the biomedical and medtech space. However, AITventures provides for relocation and startup contingencies. Thian said Phoenix's Wilkinson "basically walked in with a suitcase, his IP, and lots of experience, and started working on his business plan from day one," while AIT took care of the rest. This included infrastructure, such as office space and IT, applying for visas and looking for a place to stay, and services and technology specific to developing diagnostic technologies.
Originally hailing from the biotech hub of San Diego, Wilkinson said he recognized the collaboration provided unique opportunities. "Singapore is a relatively young hub of technology with a genuine desire to develop and incubate biotech companies like us," he said. He added that AIT facilities have "every type of molecular resource, such as [next-generation] sequencing, real-time PCR, molecular diagnostics development, and an oligo lab with enormous capabilities. So beyond the financial support, we gain the expertise and resources that would take an enormous amount of time and money to create or access elsewhere."
The Asian MDx market provides unique challenges, but also unique opportunities, according to Thian. Genetic and cultural differences impact diagnostics and drug effectiveness, so most MDx companies need to adapt their tests for Asian markets. There are also diseases and conditions more prevalent in Asia which can provide opportunities. Finally, "Asian markets have their own unique challenges when it comes to market access," he said. "One needs local expertise and experience to assist [MDx startups] to have effective market access strategies and management."
Singapore is considered a hub within the biotech space in Asia. The country has a small population of about 5 million, and "the diagnostics market is constantly evolving and exploring new technologies and platforms," Thian said. The country is also a gateway to introducing new technologies across the Association of Southeast Asian Nations, or ASEAN, and other Asian markets due to their regulations, high quality healthcare, and research and trade status with various regional countries, according to Thian.
AITbiotech will continue to develop molecular diagnostics and genomics services, as well. It is currently working on a next-generation sequencing-based cancer gene panel for detection and genetic analysis in Asian cancer patients. "We expect a specific cancer panel to be launched within next 12 to 18 months," Thian said.