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MDx/CDx Focus: Genomind's New Portal for Physicians; Overseas Regulators Positive on Kadcyla

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Genomind Introduces Physician Portal for Genecept Results

Genomind this week launched a new portal through which doctors can access their patients' results from the Genecept Assay, a test that gauges genetic markers associated with patients' ability to respond to medications for psychiatric conditions.

Through the portal, doctors will receive the Genecept Assay results for their patients electronically and download the information. The portal also sends email and text alerts to doctors to inform them that new patient results are available for review.

Genomind also intends to present news and educational materials to doctors through this portal, "making this the central point of electronic communication between Genomind and clinicians who utilize their services," the company said in a statement.

The portal is available to doctors that have ordered the Genecept Assay and is located on Genomind's website.

The Genecept Assay analyzes a proprietary panel of biomarker tests associated with response to a number of psychiatric conditions, including depression, bipolar disorder, schizophrenia, anxiety disorders, OCD, and ADHD. After testing, Genomind issues an analytic report for each patient and provides a consultation with a psychopharmacologist.


Positive Kadcyla Decisions Overseas Brings Milestone Payments for ImmunoGen

The recent regulatory decisions on the HER2-positive breast cancer drug Kadcyla (trastuzumab emtansine) from the European Union's Committee for Medicinal Products for Human Use and the Japanese Ministry of Health, Labor, and Welfare could add as much as $10 million in milestone payments for ImmunoGen.

The drug marketed by Roche subsidiary Genentech in the US received regulatory approval last year and has been available in this market. According to ImmunoGen, which developed the antibody-drug conjugate technology that Kadcyla uses, Japan and the EU are the two largest pharmaceutical markets after the US.

EU's CHMP has recommended approval of Kadcyla as a treatment for those with locally advanced, inoperable breast cancer with HER2-positive tumors who have been treated before with Genentech's Herceptin (trastuzumab) and a taxane. The committee made its decision based on the results from the Phase III EMILIA study, which demonstrated that Kadcyla compared to standard therapy significantly improved overall survival and progression-free survival in HER2-positive breast cancer patients with metastatic disease.

A decision on whether to grant marketing approval for Kadcyla is slated from the European Commission by the end of the year. If approved, ImmunoGen stands to received $5 million in milestone payments.

Meanwhile, Japanese health regulators approved Kadcyla as a treatment for recurrent or inoperable HER2-positive breast cancer based on data from a Phase II trial involving Japanese patients and the EMILIA Phase III trial. Immunogen garnered $5 million in milestone payments from this approval in Japan.

Kadcyla joins Herceptin and ImmunoGen's DM1 cytotoxic agent by a linker. Under the arrangement between Roche and ImmunoGen, Roche has global development and commercialization rights for Kadcyla, and ImmunoGen can receive milestone payments and royalties on product sales.

Roche is studying Kadcyla as a first-line treatment of HER2-positive metastatic breast cancer, for early stage disease, and for advanced HER2-positive gastric cancer. ImmunoGen is also studying several other compounds through collaborations with Amgen, Bayer HealthCare, Biotest and Sanofi.

The Scan

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A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.

Study Reveals Potential Sex-Specific Role for Noncoding RNA in Depression

A long, noncoding RNA called FEDORA appears to be a sex-specific regulator of major depressive disorder, affecting more women, researchers report in Science Advances.

New mRNA Vaccines Offer Hope for Fighting Malaria

A George Washington University-led team has developed mRNA vaccines for malaria that appear to provide protection in mice, as they report in NPJ Vaccines.

Unique Germline Variants Found Among Black Prostate Cancer Patients

Through an exome sequencing study appearing in JCO Precision Oncology, researchers have found unique pathogenic or likely pathogenic variants within a cohort of Black prostate cancer patients.