On April 5, 2017 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported the presentation of preclinical data for the Company’s lead candidate AFM13, its preclinical programs AFM24 and AFM26, as well as its MHC-peptide-targeting discovery program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting being held April 1 – 5, 2017 in Washington, D.C (Press release, Affimed, APR 5, 2017, View Source [SID1234518505]).

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"We continue to evolve and advance our leadership position in the NK-cell engager field and our unique portfolio of tetravalent, bispecific immune cell engagers," said Dr. Martin Treder, CSO of Affimed. "At AACR (Free AACR Whitepaper), we presented differentiating data on our two novel NK-cell engagers targeting EGFR and BCMA and we introduced a platform for the specific targeting of MHC-peptide complexes, which opens up the therapeutic target space of tumor-specific antigens for T-cell engagement."

AFM13 (#2997)
In a presentation on Monday, April 3, 2017, Affimed provided insights into the molecular characteristics and function of its NK-cell engagers and their potential to therapeutically reactivate NK-cells that are dysregulated in cancer. The Company’s CD16A-specific tetravalent, bispecific antibodies are welldifferentiated from native and Fc-engineered monoclonal antibodies by their high affinity and ability to overcome interference from serum IgG, leading to highly potent NK-cell activation. Furthermore, Affimed’s lead product candidate AFM13, targeting CD30/CD16A, induced upregulation of specific interleukin receptors on NK-cells in a target-dependent manner. The Company presented further evidence of AFM13 modulating NK-cells by sensitizing them to IL-2 and IL-15 stimulation. After exposure to AFM13, the NK-cells showed improved IL-2- and IL-15-mediated proliferation and cytotoxicity. In summary, these data support the strategy of combining Affimed’s NK-cell engagers with cytokines to potentially achieve deeper clinical responses.

AFM24 (#3641/14)
In a poster session on Tuesday, April 4, 2017, Affimed presented data for its first-in-class tetravalent, bispecific EGFR/CD16A-targeting NK-cell engager AFM24. Designed to address the critical unmet need in recurrent or metastatic EGFR-positive tumors, AFM24 possesses a novel mechanism of action offering higher efficacy and an improved safety profile as compared to current EGFR-targeting marketed agents. In vitro and in vivo, AFM24 shows high potency and its NK-cell killing is virtually 2 unaffected by polyclonal serum IgG interference. Importantly, AFM24 showed an excellent safety profile in toxicity studies in cynomolgus monkeys, with single intravenous administration being welltolerated up to the highest dose level of 93.75 mg/kg. In summary, AFM24 lead candidates have the potential to exhibit a favorable side effect profile and reduced toxicity and to address the resistance to other targeted anti-EGFR therapeutic agents.
AFM26 (#5671/25)
In a poster session on Wednesday, April 5, 2017, Affimed presented data for AFM26, a first-in-class BCMA/CD16A-targeted tetravalent bispecific antibody designed to redirect NK-cell cytotoxicity to multiple myeloma (MM). In vitro, AFM26 potently induced NK-cell-mediated lysis of BCMA-positive myeloma cell lines and exhibited both greater efficacy and potency than anti-CS1 IgG1 (elotuzumab). Notably, AFM26 had a much higher affinity to primary human NK-cells than native or Fc-enhanced mAbs in both the presence and absence of competing serum IgG, suggesting that AFM26 can activate NK-cells despite the high M-protein levels characteristic for MM. Furthermore, AFM26 showed significantly longer NK-cell surface retention than native and Fc-enhanced IgG formats. In summary, AFM26 alone or in combination with ex vivo-expanded NK-cells appears to be a highly promising approach to eliminate minimal residual disease (MRD) in the post-transplantation period. These data suggest that AFM26 is uniquely suited to engage NK-cells in MM. Furthermore, the long-lasting NKcell surface retention and inability to induce NK-cell depletion may allow premixing of NK-cells ex vivo prior to infusion.

MHC-peptide targeting (#3753/9)
In a poster session on Tuesday, April 4, 2017, Affimed presented data on its MHC-peptide-targeting discovery program. Addressing the need to open up the therapeutic target space of tumor-specific antigens for effective and safe T-cell engagement, the Company, together with its collaboration partner Immatics, identified a novel tumor-associated MHC/peptide complex, the HLA-A*02-binding peptide MMP1-003. MMP1-003 originates from matrix metalloproteinase 1 (MMP1), a protein overexpressed in several solid tumors and associated with advanced stage, metastasis and poor prognosis. The Company´s subsidiary AbCheck identified highly specific antibody domains (scFvs) directed against the MMP1 peptide in an MHC-complex. Using these scFvs, Affimed generated and characterized specific and potent T-cell-engaging tetravalent bispecific antibodies. The lead antibody demonstrated excellent specificity and potent cytotoxicity of endogenously target-expressing cancer cell lines and no lysis of control cell lines. In summary, Affimed has developed novel tumor-targeting antibodies with the potential to open up the therapeutic space to T-cell-engagement by providing access to intracellular proteins that are presented as disease-specific MHC/peptide complexes.

Affimed’s presentation and posters can be downloaded on Affimed’s corporate website at View Source

On April 5, 2017 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that it will present two posters in this morning’s session featuring MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company’s novel fully human antibody-based radioimmunotherapy (RIT) currently in clinical development, initially being evaluated for the treatment of pancreatic cancer and other CA19-9 positive malignancies, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held April 1-5, 2017 in Washington, D.C (Press release, MabVax, APR 5, 2017, View Source [SID1234518496]).

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Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax, stated, "We look forward to sharing the significant progress we have made through these preclinical investigations that add to a growing body of safety, efficacy, and manufacturing data supporting further development of MVT-1075 in clinical studies for the treatment of pancreatic cancer and other CA19-9 cancers. MVT-1075 represents a more potent analog of our fully human HuMab-5B1 therapeutic antibody. We believe the data being presented today bring us an important step closer in providing a much-needed treatment option for patients who have these devastating cancers."

The Company will present the following posters today, Wednesday, April 5, 2017 from 8:00 – 12:00 PM EDT:

Title: Preclinical development of MVT-1075 as radioimmunotherapy for pancreatic cancer and other CA19-9 positive malignancies
Abstract Number: 5204, Wednesday Apr 5, 2017 8:00 AM – 12:00 PM, (Houghton, et al)
Presenting Author: Toni Jun, Ph.D., Director of Pharmacology, MabVax Therapeutics, Holdings

The poster summarizes the IND supporting preclinical pharmacology, efficacy, and safety studies of MVT-1075 that supported starting dose determination and includes a synopsis of the phase I clinical trial design. These non-clinical studies include xenograft and orthotopic models of human pancreatic cancer and demonstrate tumor growth suppression and regression after a single dose of MVT-1075. These investigations provide supporting evidence that efficacy of MVT-1075 when administered as a single dose or as a fractionated dose is maintained. Fractionated doses may be useful to potentially minimize adverse effects. Biodistribution data comparing normal to tumor bearing mice demonstrate that approximately 70% of the dose administered was bound to tumor tissue within 24 hours of administration.

Title: IND enabling investigations of MVT-1075, a CA19-9 targeting Radioimmunotherapy (Gately, et al)
Abstract Number: 5206, Wednesday Apr 5, 2017 8:00 AM – 12:00 PM
Presenting Author: Paul Maffuid, Ph.D., Executive Vice President, Research and Development, MabVax Therapeutics, Holdings Inc.

The poster summarizes the chemistry, manufacturing, and controls (CMC) IND enabling investigations conducted to support the manufacture of clinical grade MVT-1075 drug product and includes details of the manufacturing process and characterization studies including product stability. MVT-1075 can be reproducibly manufactured as a high-quality product with conditions that maintain antibody affinity and integrity. Stability investigations support product manufacturing, storage and shipment to clinical trial sites.

MabVax received notification from the U.S. Food and Drug Administration (FDA) in January of 2017 to proceed with a phase I clinical trial to establish safety as well as a phase II clinical dose for MVT-1075 in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies. MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1) combines a potent radiotherapy with the tumor targeting specificity of the Company’s HuMab-5B1 antibody. The Company plans to initiate patient enrollment in during the second quarter of 2017 and evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status and early readouts on product effectiveness will be evaluated based on tumor measurements using RECIST 1.1 criteria.

In February 2017 MabVax reported encouraging positive data on the clinical safety and target specificity of the HuMab-5B1 antibody from the phase I trial of MVT-5873, the Company’s therapeutic antibody, and the phase I trial of MVT-2163, MabVax’s immunoPET imaging agent. The Company has initiated three clinical programs in the past fourteen months that are based on discovery of the HuMab-5B1 antibody from the immune responses of patients with cancer who had been vaccinated with one of the Company’s proprietary cancer vaccines.

On April 5, 2017 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, highlighted data presented during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting related to its clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) and preclinical studies of rosmantuzumab (anti-RSPO3, OMP-131R10) and GITRL-Fc trimer (OMP-OMP-336B11) (Press release, OncoMed, APR 5, 2017, View Source [SID1234518493]).

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Data from OncoMed’s Phase 1b clinical study of tarextumab in extensive-stage small cell lung cancer show changes in circulating tumor cells (CTCs) appear to correlate with overall survival outcomes. The utility of using CTCs will be evaluated further in OncoMed’s Phase 2 PINNACLE trial of tarextumab.

In a series of preclinical studies, the combination of anti-RSPO3, now known as rosmantuzumab, with paclitaxel chemotherapy demonstrated synergistic anti-tumor activity in tumors with RSPO3 translocations as well as in tumors with Wnt pathway mutations. These data may be applied in future clinical trials to determine chemotherapy combinations and/or patient selection criteria.

Another set of preclinical studies identified and characterized biomarkers in tumors and in blood following administration of OncoMed’s GITRL-Fc trimer in syngeneic murine models that may be used in upcoming clinical trials to demonstrate activity. OncoMed is preparing to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) during the first half of 2017 for its novel GITRL-Fc trimer immuno-oncology agent.
"OncoMed is pursuing extensive efforts to identify pharmacodynamic markers that deepen our understanding of the mechanisms of action of our agents, as well as predictive biomarkers that may help us identify patients whose tumors are most likely to benefit from our therapeutic candidates," said Tim Hoey, Ph.D., OncoMed’s Senior Vice President of Cancer Biology and co-Chief Scientific Officer. "The data detailed in these AACR (Free AACR Whitepaper) presentations exemplify these translational research efforts and will have direct impact in informing future clinical trial design and analyses for our tarextumab, rosmantuzumab and GITRL-Fc trimer programs."

Abstract #1727 – Circulating Tumor Cells (CTCs) in patients with extensive-stage small cell lung cancer and their association with clinical outcome
OncoMed is currently conducting the Phase 2 portion of the PINNACLE Phase 1b/2 clinical study of tarextumab in combination with standard-of-care chemotherapy in patients with extensive-stage small cell lung cancer. Researchers looked at circulating tumor cell measurements taken from patients in the Phase 1b portion of the clinical trial to assess CTCs as a predictor of response and as pharmacodynamics biomarkers. Blood samples from 26 patients were collected at baseline and following treatment with tarextumab plus chemotherapy. CTCs were measured and correlated with clinical outcomes, including progression-free survival (PFS), overall survival (OS), best overall response and metastatic status. CTCs were present in 81 percent of patients (21/26). At baseline, higher CTC counts were associated with worse survival outcomes, liver metastasis and number of metastatic sites. Following treatment with tarextumab and platinum-based chemotherapy, CTC counts were significantly decreased, indicating potential treatment effects. This effect was most evident in patients treated with the designated Phase 2 dose of tarextumab (15 mg/kg) and less apparent at lower doses. Circulating tumor cell counts will be further evaluated in the Phase 2 portion of the PINNACLE trial.

Abstract #1911 — R-SPONDIN3 antagonism sensitizes colorectal cancer to taxane treatment
OncoMed’s clinical-stage candidate, rosmantuzumab, is currently being tested in a Phase 1b clinical trial as a single agent and in combination with chemotherapy. In the preclinical studies, tumors with RSPO3 translocations and overexpression were found to be sensitive to the combination of rosmantuzumab and a taxane, including a tumor resistant to treatment with anti-RSPO3, irinotecan or the combination of the two. In addition, ten patient-derived xenograft models of colorectal cancer containing Wnt pathway activating mutations in APC or beta catenin were treated with the combination of rosmantuzumab plus taxane-based chemotherapy. In these Wnt pathway mutated tumors typical of the majority of colorectal cancers, stromal cells in the tumor microenvironment are the source of RSPO3 expression. The combination of rosmantuzumab plus a taxane resulted in synergistic inhibition of tumor growth in eight of ten models. Anti-RSPO3 plus taxane treatment significantly reduced the number of tumor initiating cells. These data indicate that the synergistic activity of RSPO3 inhibition in combination with taxane chemotherapy may be an effective means to improve clinical outcomes in colorectal cancer patients whose tumors overexpress RSPO3 or have Wnt pathway activating mutations.

Abstract #5621 – Prevalence of GITR expression and pharmacodynamic (PD) biomarkers in syngeneic tumor models treated by a GITR agonist (GITRL-Fc)
A series of experiments was conducted to characterize the prevalence of GITR expression in human cancer tissues and to identify pharmacodynamic biomarkers that reflect the mechanism of action of GITRL-Fc. GITR is expressed at varying levels in multiple solid tumors on both tumor cells and immune cells. In multiple syngeneic mouse models, GITRL-Fc trimer showed potent single-agent, dose dependent anti-tumor efficacy in large established breast, colon and melanoma tumors. Using these models, a multi-platform approach was taken to investigate GITRL-Fc pharmacodynamic biomarkers in tumors and in blood. It was found that GITRL-Fc increased the gene expression associated with cytotoxic T cells and NK cells. GITRL-Fc also activated CD4+ effector cells, decreased Treg frequency and increased the ratio of CD8+ T cell/Treg in the tumor. The pharmacodynamic biomarker changes in immune-related gene expression and immune cell populations observed in these preclinical models define the GITRL-Fc trimer mechanism of action and will be explored in the Phase 1 clinical trial planned for later this year.

On April 5, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported data demonstrating a statistically significant (p=0.03) overall survival (OS) benefit for patients with mutated p53 metastatic breast cancer, when treated with REOLYSIN, an immuno-oncology viral agent, in combination with paclitaxel (Press release, Oncolytics Biotech, APR 5, 2017, View Source [SID1234518492]). Results from IND 213, an open-label, randomized, phase 2 study were presented at the Annual Meeting of the American Association of Cancer Research (AACR) (Free AACR Whitepaper), April 1-5, 2017 in Washington, D.C.

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"Mutations of the p53 tumor suppressor gene play an increasingly challenging role throughout the life cycle of cancer," said Dr. Matt Coffey, President & Chief Executive Officer of Oncolytics. "As breast cancer progresses clinically, p53 mutations become more prominent and negatively impact therapeutic efficacy and overall survival. These data provide evidence that combining REOLYSIN with paclitaxel may improve survival for this difficult-to-treat, well characterized, patient population."

The open-label, randomized, phase 2 study enrolled 74 patients with metastatic breast cancer, 82 percent (61 patients) of whom presented with p53 mutated tumors. The results show patients with mutated p53 metastatic breast cancer that were treated with REOLYSIN in combination with paclitaxel (n=30) had a median OS of 20.9 months versus 10.4 months (n=31) in patients treated only with paclitaxel. The study was designed and conducted by the Canadian Cancer Trials Group (CCTG, formerly known as the National Cancer Institute of Canada – NCIC).

"The observed survival benefit is very exciting and reinforces the effectiveness and tolerability of REOLYSIN in patients with mutated p53 metastatic breast cancer, while demonstrating its potential utility in earlier lines of treatment for this difficult-to-treat, high-risk group of patients," said Dr. Andres Gutierrez, Chief Medical Officer of Oncolytics. "These data indicate overall survival is more than doubled for patients when treatment with REOLYSIN is added to the standard of care and highlight key considerations for the design and execution of a registration study in breast cancer. Our immediate next steps include seeking advice from key opinion leaders and regulators on refining our go-forward regulatory strategy and registration pathway."

In the abstract for the poster, the CCTG had previously reported that in the intention-to-treat patient population there was an improvement in median OS (secondary endpoint) from 10.4 months on the control arm to 17.4 months on the test arm (Hazard ratio 0.65, 80% CI 0.46-0.91, p=0.1) meeting the pre-specified significance threshold with powering of 90 percent. Consistent with REOLYSIN acting as an immune therapy agent, there was no meaningful improvement in either progression free survival (the primary endpoint), or response rate (secondary endpoint). With this overall survival data and the additional data from the p53 patient group, the company has commenced the planning of a registration study in metastatic breast cancer with overall survival as the primary endpoint.

The poster, authored by Bernstein et al, "A Randomized (RCT) Phase II Study of Oncolytic Reovirus (Pelareorep) plus Standard Weekly Paclitaxel (P) as Therapy for Metastatic Breast Cancer (mBC)" will be available on the Oncolytics website at: View Source

About Breast Cancer
The National Cancer institute reported 246,660 new cases of breast cancer diagnosed in the United States and 40,450 deaths from the disease in 2016.

On April 5, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that it has published the third clinical validation study and second clinical utility study for its myPath Melanoma test, which completes the reimbursement dossier for the product (Press release, Myriad Genetics, APR 5, 2017, View Source [SID1234518491]). The Company also announced it will submit the reimbursement dossier to Medicare and private insurers three months earlier than expected. myPath Melanoma is an objective genetic test that measures 23 genes to help differentiate malignant melanoma from benign lesions.

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"The pivotal results from these two studies join a number of additional publications, which is the culmination of five years of extensive scientific research and innovation," said Vicki Fish, vice president, Dermatology Business Unit, Myriad Genetic Laboratories. "We believe that our reimbursement dossier is exceptionally strong, and we will work with health plans to ensure this test is widely accessible to the physicians and patients who need it."

The third clinical validation titled "Diagnostic Distinction of Malignant Melanoma and Benign Nevi by a Gene Expression Signature and Correlation to Clinical Outcomes" was published in the journal Cancer Epidemiology, Biomarkers & Prevention. The study assessed the performance of the myPath Melanoma test in an independent cohort of 182 patients with melanocytic lesions against clinically proven outcomes (99 primary melanomas with distant metastases and 83 benign moles). The median time to melanoma metastasis was 18 months and the median follow-up time for benign moles was 75 months. The results showed that the myPath Melanoma test had an overall diagnostic accuracy of 95 percent to effectively differentiate melanoma from benign lesions. These strong findings demonstrate that the myPath Melanoma test closely correlates with long-term clinical outcomes and adds valuable information to assist in the accurate diagnosis of melanoma.

The second clinical utility study titled "The Influence of a Gene Expression Signature on the Treatment of Diagnostically Challenging Melanocytic Lesions" was published in the journal Personalized Medicine. This study was designed to evaluate changes in real world patient management based upon the myPath Melanoma test result. Samples from 77 patients with suspicious skin lesions (i.e., melanocytic neoplasms) were tested using the myPath Melanoma test accompanied by pre-test documentation of the intended treatment recommendations. The actual treatment provided by dermatologists was then documented after testing. The results showed there was a 71 percent change in patient management from pre-test recommendations and an 81 percent reduction in biopsy site re-excisions for patients with a benign test result. Based on these findings, the myPath Melanoma test significantly influenced the physicians’ treatment of patients.

A list of the key analytic validation, clinical validation and clinical utilities studies that comprise the myPath Melanoma reimbursement dossier follows below.

Key Elements of myPath Melanoma Reimbursement Dossier

Study Key Result Peer-Reviewed Publication
Clinical Validation 1 (n=437) • >90 percent diagnostic accuracy Journal of Cutaneous Pathology (2015)
Clinical Validation 2 (n=736) • >91 percent diagnostic accuracy Cancer (2016)
Clinical Validation 3 (n=182) • >95 percent diagnostic accuracy Cancer Epidemiology, Biomarkers & Prevention (2017)
Analytic Validation (n=544) • Only 2.5 percent standard deviation of the score High dynamic range, precision, RNA yield Biomarkers in Medicine (2015)
Clinical Utility 1 ( n=218) • >50 percent increase in definitive diagnoses for cases that were originally diagnosed as indeterminate.
• ~50 percent change in treatment recommendations for diagnostically challenging cases. Medicine (2016)
Clinical Utility 2 (n=77) • 71 percent change in patient management from pre-test recommendations
• 81 percent reduction in excisions for patients with a benign test. Personalized Medicine (2017)
Health Economic • 8.3 percent reduction in 10-year costs per patient.
• Savings of $.067 per member per month. Journal of Medical Economics (2014).

"Melanoma is one of the fastest growing cancers in the United States, and there is demand among physicians for an objective, high quality, clinically validated molecular diagnostic test to be used as an adjunct to conventional tools like the microscope," said Loren Clarke, M.D., board-certified dermatopathologist and medical director, Dermatology, Myriad Genetic Laboratories. "We believe myPath Melanoma is one of the most studied and accurate molecular diagnostic tests ever developed. It has enormous potential to help save the lives of people with melanoma, spare people with benign moles from unneeded treatment and lower costs for our healthcare system."

Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates about myPath Melanoma from the Company.

About Melanoma
Melanoma is one of the fastest growing cancers in the United States and can strike people of all ages, races and skin types. With a one-in-50 lifetime risk of developing melanoma, nearly 87,000 Americans are expected to be diagnosed with Stage I-IV melanoma and another 75,000 will be diagnosed with melanoma in situ — totaling approximately 162,000 total diagnoses. Early and accurate diagnosis of melanoma is critical for long-term survival. For more information visit: www.mypathmelanoma.com/.

About Myriad myPath Melanoma
Myriad myPath Melanoma is a clinically validated test to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. The test measures the expression of 23 genes and accurately distinguishes melanoma from benign nevi.