By Ben Butkus
BioSample Solutions has received a $70,000 investment from a state economic-development agency to help it develop its new nucleic acid-extraction method for downstream amplification and clinical diagnostics, the company's founder said this week.
In addition, the Bethlehem, Pa.-based startup is collaborating with Sparton Medical Systems, the medical device division of electronics and manufacturing services firm Sparton, to automate the sample-prep method, PCR Insider has learned.
BioSample Solutions' technology, dubbed BioCookie, aims "to give people [the extracted nucleic acid volume] they want, and no more," founder Chiu Chau told PCR Insider this week. "They don't need 200 microliters of DNA," he said, adding that typically 5 microliters is enough. "They have no idea what to do with it. They store it and then throw it away after five years."
To support this effort, Ben Franklin Technology Partners of Northeastern Pennsylvania has invested $70,000 in the company. In addition, BioSample and Sparton, which has a facility in Strongsville, Ohio, have filed a letter of intent with state funding group the Ohio Third Frontier Biomedical Program, requesting an additional $500,000 in funding.
In their letter, BioSample and Sparton claim that an automated version of the method they are developing would be "user-friendly;" would "decrease process and training time of operators;" and would require "a very small sample amount, which is the driving force to resolve errors with contamination."
The companies have also said they intend to integrate automation hardware with the platform's consumable "into a bench-top platform to be clinically trialed for research labs by the second year. In the third year, a 510(k) [application] will be submitted and the plan is to penetrate the multi-billion dollar diagnostics field while both the hardware and the consumables are being produced here in Ohio, utilizing Ohio-based supplier-partners."
In addition, BioSample is currently in discussions with potential collaborators at various academic institutions and an undisclosed diagnostic developer. The company added that it is working with one academic collaborator on a proof-of-concept publication.
DNA Runneth Over
BioSample Solutions aims to change the way DNA and RNA are isolated and purified from patient samples such as blood and saliva and used in PCR amplification and molecular diagnostics, Chau said.
Chau, who has experience in multiplex PCR, blood banking, and other molecular diagnostic-related markets, said that he believes the testing aspect of the diagnostics is more or less as strong as it is going to get.
"As I see it … everything on the multiplex PCR side is done. It's rock solid," Chau said. "The issue nowadays is not really getting the data, but how do you process the sample? And if you have a lot of samples, it gets really messy."
The most commonly used nucleic acid extraction and purification technologies — magnetic beads and spin columns — work well, but offer no control over the amount of genetic material being extracted, Chau explained.
"They give you far more than what you want in diagnostics," he said. "You need to give people only what they need. Because once they've done the extraction, they want to move on. They don't need 200 microliters of DNA. They have no idea what to do with it."
According to Chau, most researchers and clinical labs only need about 5 microliters of DNA or RNA to serve as a template for downstream amplification and diagnostic testing, although certain applications will necessitate more, and others less.
"My goal is to solve the problem differently," said Chau. "People know what they want. They only need 5 microliters of DNA, and if you can provide it quickly and cheaply, that's great." Second, he said, the method needs to be able to precisely provide the correct DNA range for technologists or researchers to use for PCR amplification.
"That's one of the biggest drawbacks for all these existing technologies, that you have no idea what the DNA output is," and that's where BioSample Solution hopes BioCookie can make a difference.
Chau declined to detail exactly how BioCookie works, citing the early and proprietary nature of the technology. The company just filed its first patent applications on the method last year, and they have yet to be published.
However, Chau said it "gives you precise control of the DNA yield, so downstream you can solve that headache of having to worry about too much or too little."
Besides the Ben Franklin investment, BioSample has also secured a small investment from private individuals, according to Chau.
"We have some investors already, and the company has been able to raise some money – not substantial, because I don't want substantial dilution," Chau said.
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