BARD1 Life Sciences (ASX:BD1), a medical technology company developing non-invasive cancer diagnostics, announced it has reached the phase three milestone of its contracted assay development program to transfer its BARD1 assay to the Luminex platform.
The company said it has completed the evaluation of the pilot research use only (RUO) BARD1 kits and signed off on the phase three assay validation milestone under the contract development agreement with Thermo Fisher Scientific.
Luminex is an industry-standard diagnostic platform widely used for the development and commercialisation of multi-analyte diagnostic tests.
"This is an important step for the Company in advancing the development of our BARD1 autoantibody tests, with the aim of verifying the RUO BARD1 kit can be developed to detect ovarian cancer and ultimately leading to commercialisation and making our blood tests for early detection of cancer available to patients," said the company in a statement.
BARD1 said it is now ready to commence the next optimisation phase for tests on schedule in the fourth quarter of 2019.
BARD1 said it has agreed with Thermo Fisher to extend the contract development agreement during this phase for additional work to optimise and improve the RUO BARD1 kit in ovarian cancer samples.
According to CEO Dr Leearne Hinch, “The phase 3 milestone under the contract development agreement with Thermo Fisher has been completed on time and we are extremely pleased to extend the agreement with Thermo Fisher into the test optimisation phase given their expertise in assay development.
"This is an important step towards BARD1’s goal of developing a screening test for early detection of ovarian cancer to fill this critical unmet need in women’s health.”