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Precision Medicine

LineaRx’s iCTC Platform for Isolation of Circulating Tumor Cells Shows Superior Correlation over PSA as a Biomarker in Prostate Cancer Trial

STONY BROOK, N.Y.–(BUSINESS WIRE)–LineaRx, Inc., the majority-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN) focused on next-generation biotherapeutics, announced today that its invasive Circulating Tumor Cells (iCTCs) platform demonstrated superior correlation over Prostate Specific Antigen (PSA) in an ongoing Phase II trial in recurrent prostate cancer. Most notably, the concentration of …

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Foundation Medicine and Natera Partner to Advance Personalized Cancer Monitoring

CAMBRIDGE, Mass. and SAN CARLOS, Calif., Sept. 25, 2019 /PRNewswire/ — Foundation Medicine, Inc. and Natera, Inc. (NASDAQ: NTRA) today announced a partnership to develop and commercialize personalized circulating tumor DNA (ctDNA) monitoring assays, for use by biopharmaceutical and clinical customers who order FoundationOne®CDx. The initial focus of the partnership …

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FDA Grants Merck KGaA’s Tepotinib Breakthrough Therapy Designation for Patients with Metastatic NSCLC with METex14 Skipping Alterations

DARMSTADT, Germany, Sept. 11, 2019 /PRNewswire/– Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its biopharmaceutical business as EMD Serono in the US and Canada, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational targeted therapy tepotinib* …

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Study Published by Clinical Cancer Research Shows PGDx’s Liquid Biopsy Predictive of PD-1 Blockade Response

BALTIMORE–(BUSINESS WIRE)–A study published by Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR), shows Personal Genome Diagnostics Inc.’s (PGDx) liquid biopsy technology successfully detected microsatellite instability (MSI) in circulating tumor DNA (ctDNA), and was able to estimate the likelihood of both an immediate and durable response …

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Thermo Fisher Scientific Signs Agreement with Lilly for Companion Diagnostic to be Used with RET Inhibitor

CARLSBAD, Calif., Sept. 9, 2019 /PRNewswire/ — Thermo Fisher Scientific today announced an agreement with Eli Lilly and Company for development of a companion diagnostic that will use the U.S Food and Drug Administration-approved, next-generation sequencing-based Oncomine Dx Target Test to identify certain non-small cell lung cancer (NSCLC) and thyroid …

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Boehringer Ingelheim Expands KRAS Cancer Program with Lupin’s Investigational MEK Inhibitor

Ingelheim, Germany and Mumbai, India – 4 September 2019 – Boehringer Ingelheim and Lupin Limited (Lupin) today announced a licensing, development and commercialization agreement for Lupin’s MEK inhibitor compound (LNP3794) as a potential targeted therapy for patients with difficult-to-treat cancers. The partnership aims to develop Lupin’s lead MEK inhibitor compound in …

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International Team Discovers Unique Pathway for Treating Deadly Children’s Brain Cancer

PHOENIX, Ariz. — Aug. 22, 2019 — An international team of researchers led by Yale University, University of Iowa, and the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, has discovered a new pathway that may improve success against an incurable type of children’s brain cancer. The …

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FDA Approves Genentech’s Rozlytrek for Patients with ROS1-Positive Metastatic NSCLC and NTRK Gene Fusion-Positive Solid Tumors

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to …

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Onconova Therapeutics and Mission Bio Partner to Advance Precision Oncology Clinical Trials Employing Single-Cell Genomics

NEWTOWN, Pa. and SOUTH SAN FRANCISCO, Calif., Aug. 12, 2019 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), and Mission Bio, the pioneer in targeted single-cell DNA analysis and precision genomics, …

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FDA Accepts Blueprint’s NDA for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

CAMBRIDGE, Mass., Aug. 7, 2019 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for avapritinib for the treatment of …

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