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In Brief This Week: Myriad Genetics, Precipio, LumiraDx, Guardant Health, and More

NEW YORK – Myriad Genetics said this week it will start receiving reimbursement in Japan for its BRACAnalysis Diagnostics System as a companion test to identify which metastatic pancreatic or metastatic castration-resistant prostate cancer patients harbor germline BRCA1/2 mutations and are likely to benefit from the PARP inhibitor olaparib (AstraZeneca/MSD's Lynparza). Following the test's approval in these settings by Japan's Ministry of Health, Labor and Welfare in October, the government will now reimburse the test. The latest approval and reimbursement of BRACAnalysis expands the test's utility beyond the BRCA1/2-mutated breast and ovarian cancer setting where it is already approved as a companion test for olaparib.


Cancer diagnostics firm Precipio said this week that two oncology practices, West Cancer Center in Tennessee and New York Cancer & Blood Specialists, will be implementing its HemeScreen cancer mutation profiling panel in their internal labs. In December, the company announced it was working with an unnamed oncology distributor to launch the HemeScreen Physician Office Lab (POL) program to make its molecular profiling technology for hematologic malignancies available to community practices. By bringing the HemeScreen test in-house, these practices will be able to "significantly improve" the turnaround time for molecular test results for hematologic malignancies, such as myeloproliferative neoplasms, chronic lymphocytic leukemia, and acute myeloid leukemia, Precipio said. The company had previously estimated that an average practice in the HemeScreen POL program could potentially generate $100,000 in reagent sales, depending on its size.


LumiraDx said this week that regulators at Japan's Pharmaceutical and Medical Devices Agency and Brazil's Agência Nacional de Vigilância Sanitària have approved the firm's SARS-CoV-2 Antigen test, making it available in more than 30 countries. LumiraDx said it will launch the test in those countries shortly. The firm's antigen test received Emergency Use Authorization from the US Food and Drug Administration in August, and it received EUAs for PCR-based tests for SARS-CoV-2 the same month and in October.


Guardant Health and the Vall d’Hebron Institute of Oncology said this week that they are working together to establish an in-house cancer genomic testing service at VHIO’s Barcelona facility using Guardant's proprietary digital sequencing liquid biopsy platform.

Vall d’Hebron's new service is expected to become operational before the end of this year and will be available for both research and clinical care. According to the partners, testing will be limited to private-paying patients at first, though the institute expects to be able to gain coverage for patients in the public healthcare system over time.


Diagnostics data analytics company Diaceutics said this week that it is working with Canadian Pathology Quality Assurance (CPQA) to advance NTRK immunohistochemistry proficiency testing. With the availability of precision oncology drugs that target NTRK fusions, there is a growing need to test for these biomarkers and to establish proficiency testing programs in this area, Diaceutics said. The CPQA will use Diaceutics' recently launched DXRX platform to work with labs to source formalin-fixed paraffin-embedded tissue blocks and build a small tissue microarray for NTRK IHC proficiency testing and test validation assistance. The CPQA is particularly interested in getting access to secretory breast cancer and salivary mammary analogue secretory carcinoma tissue blocks, which are more likely to have NTRK fusions.


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.