'Just add water' works for BTF

There must be something in the water in Sydney’s North Ryde that encourages biotech.

It has nurtured some of Australia's most successful life science companies, from industry veterans Peptech and ResMed to the rapidly maturing Proteome Systems.

Mow there's young microbiology specialist BTF -- a company that produces tiny pellets containing precisely 30 bacteria.

But why would you want to do that? BTF managing director Mark Gauci explains that the request for a product which contained an accurate, consistent amount of bacteria, able to be cultured into a determinable number of colonies came from the US Environmental Protection Agency, already a customer for BTF’s Cryptosporidium control.

Gauci and his business partner microbiologist Graham Vesey were initially stumped. Bacteria are fickle, elusive organisms, likely to either die or multiply without notice. The idea of capturing, counting and transporting an exact number must have seemed like a fool’s errand.

“Initially we said, 'There’s no way you can do that',” said Gauci. “It took us a month or two of Saturday mornings and some crazy ideas before we hit upon a solution.”

Although established in 1996 on the back blocks of Macquarie University, BTF hit its stride during the Sydney Water crisis in 1998. Until then, systems for testing for Cryptosporidium -- a single-celled protozoan which causes diarrhoea and is resistant to chlorine disinfection -- had been haphazard at best.

“The laboratories [to which samples of Sydney water were sent] came under intense scrutiny,” said Gauci. “The whole industry realised that all the tests were inaccurate and it was difficult to get agreement between experts.”

The solution lay in an immunofluorescent monoclonal antibody Vesey had been working on, which was able to latch on to Cryptosporidium oocytes and Giardia cysts, which then fluoresce either red or bright green.

To detect and count the oocytes and cysts, Gauci drew on his background in optoelectronics to adapt a flow cytometer -- normally used to detect and characterise blood cells -- to sort and count tubes of exactly 100 Cryptosporidium oocytes.

These precise reference samples -- marketed as EasyStain and EasySeed -- were used by Sydney Water as controls to validate their testing procedures, and have gone on to win regulatory approval in the US, Japan and the UK. They are now effectively the gold standard in 16 countries.

“BTF’s control and reagents business has been growing at about 30 per cent per annum since 2000,” said Gauci.

Graduating from an after-hours-in-the-lab concern to a business with $2 million in sales this year hasn’t been without its struggles. The company was initially cobbled together with an IP license from Macquarie University, an $847,000 federal government R&D Start grant -- which allowed Gauci and Vesey to start paying themselves -- a rented flow cytometer, and a room donated by Proteome Systems’ CEO Keith Williams.

It was here that their ‘BioBall’ technology was developed, allowing a roll-call of precisely 30 bacteria to be corralled and freeze dried.

“We used the flow cytometer as a cell dispenser," Gauci says. "Effectively it analyses cells on-by-one and we can define the characteristics of cells by size and sort them.

“[The bacteria emerge] into a droplet of nutrient fluid which falls from the flow cytometer on to liquid nitrogen, where it is freeze dried, and then packaged into a vial.”

When a scientist at one of BTF’s 20 customers -- which include the US EPA and the US Army -- wants to reconstitute the bacteria ‘pill’, it’s a case of 'just add saline solution'.

In 2002 some of the industry players began to take notice. Venture capitalist Nanyang invested $2 million in the fledgling company for business development and commercialisation of new products. Biotechnology incubator Xcelerator, a North Ryde neighbour, was also an early supporter.

Now, Gauci says, the company is making inroads into the Australian and US food-testing market, and is eyeing the pharmaceutical testing market. “Labs at the moment need to use their own samples as controls, which is an erroneous practice,” he said.

The BioBall library already includes 14 common bacterial strains, among them three types of Salmonella and the ubiquitous E. Coli. Gauci is planning to have 50 strains on the market in the next 2 years.

Gauci and his colleagues are currently bent on persuading food-processing laboratories to switch their quality control spending to the BioBall consumables, moving spend away from staff time and laboratory resources. The company also faces a fragmented regulatory regime which includes the US Food and Drug Administration and the US Department of Agriculture. It is angling for a product release of its microbiological reagents -- including BioBalls -- in Japan in October.

Meanwhile, the prospect of fluorescent salmonella in contaminated food and a huge food testing market beckon.