Statement from FDA Commissioner on the FDA’s new effort for developing and class labelling of in vitro companion diagnostics for classes of oncology therapeutic products

6 December 2018 - One challenge we face right now, when it comes to developing diagnostics that can help target ...

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FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

4 December 2018 - The U.S. FDA today took a significant step forward in driving the efficient development of novel diagnostic ...

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'Death sentence': One-in-a-million rare cancers get the 'sorting hat' treatment

13 November 2018 - For people with the rarest of cancers, the hope of survival or an effective treatment can ...

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Medicare-funded cancer genetic tests: a note of caution

3 September 2018 - Clinicians need appropriate education and support in keeping pace with the genomics revolution. ...

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Rule out chemotherapy for early breast cancer - but first take a $5,000 test

4 June 2018 - There is good news for women with early breast cancer, but for Australians it comes at ...

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Cutting-edge cancer drug hobbled by diagnostic test confusion

9 April 2018 - Physicians struggle to identify which patients are likely to respond to a recently approved therapy. ...

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DNA on drugs: how genetic tests could make prescriptions more precise

16 March 2018 - It’s well known that different people can react differently to the same drug, with some patients feeling ...

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CMS finalises coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients

16 March 2018 - A new opportunity for cancer patients as advanced diagnostic laboratory tests now have expanded Medicare coverage. ...

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August 2018 PBAC special meeting

19 February 2018 - Options for listing of pan-tumour indications for PDL-1 cancer immunotherapies on the PBS. ...

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Cost-effectiveness analysis of germ-line BRCA testing in women with breast cancer and cascade testing in family members of mutation carriers

4 January 2018 - This study evaluated the cost-effectiveness of BRCA testing in Australian women with breast cancer, and cascade ...

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Breast cancer: BRCA study sent to Canada because U.S. thinks women can't handle genetic test results

19 October 2017 - Hundreds of spit samples have been traveling through the mail across the U.S.-Canadian border. Why? The ...

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Concept paper on development and lifecycle of personalised medicines and companion diagnostic

28 July 2017 - Public consultation to end on 31 October 2017. ...

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FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas

29 June 2017 - The U.S. FDA today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first ...

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Australian-first whole genome sequencing and health testing open to public

20 June 2017 - An Australia-first service that combines whole genome sequencing and a comprehensive health assessment could offer individuals ...

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Integrating companion diagnostics into CDR and pCODR reviews

13 June 2017 - In November 2016, CADTH invited stakeholder comments and feedback on a proposed process for the assessment ...

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