In August 2016 BCAL Dx welcomed Carl Stubbings to head the company’s commercialisation efforts. Carl has considerable experience in the commercialisation of diagnostic products with a particular focus on the USA. Carl’s bio is available on the BCAL Dx website.
Regulatory Strategy and Market Roll Out
BCAL Dx is pleased to report that the company has finalised our launch strategy for the BCAL Test, focusing on the USA and Australia. The test will be launched in the US as a “Laboratory Developed Test” (LDT) which is defined as an in vitro diagnostic test that is manufactured by and used within a single Clinical Laboratory Improvements Amendment (CLIA) certified “high complexity” laboratory. This pathway to market is a common one utilised by a number of laboratory providers in the USA. In 2014 over 244,000 different tests were noted as being regulated by CLIA and not the US Food and Drug Administration (FDA). This approach is also available in Australia, where the company will undertake a similar strategy. The LDT approach could enable the BCAL Test to become available in late 2017 or early 2018, a significantly shorter pathway compared to FDA and Therapeutic Good Authority (TGA) approvals. In parallel, BCAL Dx will also initiate a regulatory strategy with a goal of obtaining approvals from the FDA and TGA (Australia) by Q2 2019 further broadening uptake of the BCAL Test.
During the last 12 months BCAL Dx, in conjunction with our US collaborators at University of Kentucky and Sevident Technologies, have made excellent progress towards finalising a testing platform that will enable the BCAL Test to be easily scalable into a routine pathology laboratory setting. The company expects to finalise this important step in Q1 2017.
This milestone will coincide with the completion of an important clinical trial. In January 2017, BCAL Dx expects to complete a 110 patient blind study which will further validate the scientific foundation behind the BCAL Test.