Tag Archives: diagnostic test

December, 2018

5 December
FDA Authorizes First Test to Aid in Detecting Cytomegalovirus in Newborns

Today the U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. “Although most people who become infected with cytomegalovirus face little to no risk of serious illness, …
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4 December
FDA Approves Foundation Medicine’s Comprehensive Companion Diagnostic Test for Solid Tumors

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx™, the company’s comprehensive companion diagnostic test for solid tumors. FoundationOne CDx is intended for use by health care professionals to help inform cancer treatment management in accordance with professional guidelines for patients …
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1 May
Castle Biosciences’ DecisionDx-Melanoma Test Accurately Predicts Metastatic Risk in Patients with Head and Neck Melanoma

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced results from a study evaluating the prognostic accuracy of the DecisionDx®-Melanoma gene expression profile (GEP) test in a cohort of patients with head and neck melanoma. Results demonstrated that the DecisionDx-Melanoma test accurately identifies …
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6 March
Study Confirms Accuracy of OncoCyte’s Blood Test for Early Detection of Lung Cancer

ALAMEDA, Calif., March 06, 2017 (GLOBE NEWSWIRE) — OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests to aid in the early detection of cancer, today reported the successful completion of a critical step in the development of its lung cancer diagnostic test. While the key performance …
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7 November
Roche’s VENTANA ALK (D5F3) CDx Assay Receives FDA Approval

TUCSON, Ariz., Nov. 7, 2016 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX:RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved the VENTANA ALK (D5F3) CDx Assay1 for use on the VENTANA BenchMark ULTRA automated slide stainer. The assay is a companion diagnostic to aid in the …
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12 October
Celgene and Agios Collaborate with Abbott for Diagnostics Identification of IDH Mutations in AML

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) and Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) today announced each company has entered into collaboration agreements with Abbott (NYSE: ABT), a leader in diagnostic technologies, to develop and commercialize companion diagnostic tests on Abbott’s m2000 RealTime System to identify isocitrate dehydrogenase (IDH) mutations in …
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3 December
MetaStat Presents Positive Data for its Breast Cancer Diagnostic Test

BOSTON–(BUSINESS WIRE)–MetaStat, Inc. (OTCQB:MTST), a molecular diagnostic company, today presented positive results from an analytical validation study demonstrating the analytical accuracy, reproducibility, and precision of its MetaSite Breast™ test at the Tumor Metastasis meeting of the American Association for Cancer Research (AACR) in Austin, Texas. The MetaSite Breast™ test predicts …
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25 November
SkylineDx Receives CE-IVD Mark for its Gene Signature-Based Test for Multiple Myeloma

ROTTERDAM, Netherlands and LAGUNA HILLS, Calif., Nov. 25, 2015 /PRNewswire/ — SkylineDx, today announced they have received CE-IVD registration from the European Competent Authority (Ministry of Health) for the MMprofiler™, the company’s prognostic test to determine the level of risk of a patient with multiple myeloma (MM). SkylineDx is an emerging …
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19 October
FDA Approves Roche’s HBV and HCV Viral Load Tests

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received FDA approval for the cobas® HBV and cobas® HCV viral load tests, the first assays approved by the United States Food and Drug Administration (FDA) for use on the cobas® 6800 and cobas® 8800 Systems. The fully automated …
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22 May
Biodesix Launches its Liquid Biopsy Mutation Test for Lung Cancer Patients

Biodesix, Inc. has launched its targeted liquid biopsy mutation test for patients with advanced lung cancer. The molecular diagnostics company announced the launch of GeneStrat, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer (NSCLC). The results from the blood test are …
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