RE:RE:RE:Helomics Article Mentions Med Biogene/Gene Fx Lunghere`s part of it.
With the changes, Helomics has shifted the business to be more research-oriented and to do contract research services, such as biobanking, as "a precursor to the clinical utility products," Campbell said.
Helomics' assays are offered as laboratory-developed tests that are run in its two CLIA laboratories in Pittsburgh, and during the next few years, it plans to add additional CLIA facilities elsewhere, Campbell said. Helomics does not have plans currently to offer its assays as kits, which would be too expensive and time-consuming, he added.
According to Campbell, the firm's focus is not in the US – although one of its goals is to increase its US customer base – but rather in the UK and potentially Canada, two countries that are taking a more holistic approach to personalized healthcare than the US, where obstacles such as the Health Insurance Portability and Accountability Act and FDA regulations limit access to patient data, he said.
The UK, by comparison, allows a firm such as Helomics greater access to patient data, Campbell said, which it can then use for research. And earlier this month, Helomics joined the UK Personalised Healthcare Alliance as a founding member.
According to the alliance's LinkedIn page, its objectives are to collaborate with stakeholders "to build better alignment"; advocate for personalized healthcare; promote the UK in the personalized healthcare space; and educate stakeholders about the space "to inform dialogue, build political support, and improve patient outcomes." Additional members of the alliance include AstraZeneca, Biogen Idec, Cancer Research UK, Epistem, Horizon Discovery, and others.
As part of its involvement, Helomics will provide funding for the effort and will work collaboratively with other members on projects. In addition to being able to access data, Helomics will have access to clinical samples in the UK, Campbell said.
In Canada, the firm has started relationships to offer services similar to what it offers in the US and Helomics is exploring potentially partnering on CLIA-equivalent labs in the UK and Canada, Campbell said.
Also in Helomics' plans is an expansion of its companion diagnostic business. The firm currently has six CDx deals with pharmaceutical firms in the very early stages, though Campbell declined to identify them.
Meanwhile, diagnostics remains very much on Helomics' radar, and as it progresses on its new business model, it intends to launch new products in the first half of 2015, including GeneFx Colon, a 634-transcript DNA gene signature microarray-based assay for stage II and III colon cancer risk assessment. The technology is licensed from Almac Diagnostics, a division of the Almac Group.
Also planned is a launch of GeneFx Lung, a 15-gene assay for non-small cell lung cancer. The company plans to launch the product to the research market in the first quarter of 2015 and then as an LDT in the second quarter. The test is licensed from Med BioGene.