Molecular diagnostics has promised much for many years, but the full potential of the market is just being realised.

In June this year, US company Hologic announced it proposed to acquire another US company, Third Wave Technologies, for the reasonable sum of $580 million.

This follows the acquisition by German life sciences technology company Qiagen – which recently snapped up Australian instrument developer Corbett Life Sciences – of diagnostic pioneer Digene for US$1.6 billion.

Digene manufactures probably the most popular human papillomavirus diagnostic test on the market. Third Wave Technologies is also in the HPV field, set to shortly commercialise Cervista, its HPV test, which still subject to FDA approval.

The field is not limited to sexually transmitted diseases but these are the first cabs off the rank in molecular diagnostics, the future of which is unlimited.

Also in the field is Genera Biosystems, a newly listed company based in Melbourne that was set up to commercialise a portfolio of technologies originally developed by scientists from the Walter and Eliza Hall Institute, the Australian Genome Research Facility and the University of Melbourne.

Genera has developed a silica bead-based technology called AmpaSand that provides a full platform of DNA analysis technologies, initially focused on women’s health but promising a whole lot more.

Genera was initially spun out of WEHI in 2001 with a view to providing single nucleotide polymorphism (SNP) services to the academic community. This was never going to prove a competitive business in a growing field, but the SNP technology was always interesting from a diagnostic perspective.

Several years ago, Dr Karl Poetter, who had developed a process to detect SNPs by means of a different annealing temperature, called Sequence Identification by Flow Technology (SiFT) and was a founder of Genera, was approached by local pathology company Gribbles, now part of Healthscope, to help develop an HPV genotyping assay, which today has become PapTest.

PapTest is now available through Gribbles, which has validated the test using Australian Standards through NATA and the National Pathology Accreditation Advisory Council (NPAAC), but it is hoped the test will become more widely available after hoped-for approval from the TGA and in different jurisdictions next year.

Genera’s CEO, Dr Allen Bollands, says the technology differs from others in development and on the market because it is an all-in-one test with no requirement to buy expensive equipment to run the test.

For example, Digene’s test requires laboratories to buy not only the kit but the equipment to run it as well. Third Wave Technologies plans to initially screen patients for high-risk HPV using a non-genotyping test, and then genotype those specimens found to be high risk, looking for types 16 and 18, which cause 70 per cent of cervical cancers.

“Not only does PapType detect and genotype in a single test, it genotypes all 14 high-risk types of HPV, rather than just type 16 and 18,” Bollands says. “These other 12 high-risk types are responsible for approximately 30 per cent of all cervical cancers and the currently available vaccines offer, at best, limited protection against these types.”

Using Genera’s platform technology, the company is also developing a three-in-one STD test, to include the other big problems in sexual health, Chlamydia trachomatis and Neisseria gonorrhoea.

“The Chlamydia and gonorrhoea test is at a fairly advanced stage now and will have some advantages over existing CT/NG tests,” Bollands says.

“Those advantages are conferred by the fact that we are using this bead-based system means that we are able to multiplex different markers together and means we are able to extract extra information useful for pathologists.”