On October 21, 2018 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") is pleased to announce that it has closed its offering (the "Offering") of 17,144,314 units (the "Units") at a price of US$0.70 (the "Offering Price") for gross proceeds of approximately US$12 million in the United States and the Canadian provinces of Alberta, British Columbia, Manitoba, Ontario and Quebec (Press release, IntelGenx, OCT 22, 2018, View Source [SID1234530112]).

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Each Unit consists of one share of common stock (the "Offered Shares") and one half of one warrant (a "Warrant"), each whole Warrant entitling the holder to purchase one share of common stock of the Company at an exercise price of US$1.00 per share. The Warrants are exercisable immediately and will expire on the third anniversary of the date of their issuance.

The Units were distributed under a final prospectus supplement to the U.S. registration statement on Form S-3 (File No. 333-227498) which was declared effective on October 15, 2018 (the "Registration Statement") and a final Canadian MJDS prospectus supplement to the Canadian MJDS short-form base shelf dated October 18, 2018 filed by the Company in connection with the Offering. Copies of the U.S. prospectus supplement and the Registration Statement can be obtained from the SEC’s website at www.sec.gov.

Copies of the final prospectus supplement and the Registration Statement may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected].

The Offering was conducted, on a best efforts basis, by H.C. Wainwright & Co. ("Wainwright"), in its capacity as the exclusive placement agent for the Units offered in the United States, and Echelon Wealth Partners Inc., in its capacity as the exclusive placement agent for the Units offered in Canada ("Echelon" and collectively with Wainwright, the "Agents").

The Company has granted Echelon an over-allotment option exercisable, in whole or in part, at the sole discretion of Echelon, at any time prior to 5:00 p.m. (Montreal time) on the date that is the 30th day after the closing of the date hereof, to purchase shares of common stock of the Company and/or Warrants in an amount representing up to an additional 15% of the number of Units sold pursuant to the Offering, at the Offering Price to cover over-allocations, if any, and for market stabilization purposes.

The TSX Venture Exchange (the "TSXV") has conditionally approved the listing of the common stock that will be issued by the Company in the Offering, including the shares of common stock issuable upon the exercise of the Warrants. Listing on the TSXV will be subject to the Company fulfilling all of the listing requirements of the TSXV within 30 days of the closing of the Offering.

After the payment of the Agents’ commissions and the reimbursement of certain of the Agents’ Offering expenses and the payment of other Offering expenses, the Company expects the net proceeds from the Offering to be approximately US$10.5 million. The Company intends to use the net proceeds from the Offering for its 2a Montelukast Study, its Tadalafil 505(b)(2) submission to the U.S. Food and Drug Administration, and working capital.

On October 22, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported the presentation of data from two clinical trials for PEGPH20 (pegvorhyaluronidase alfa) in patients with advanced pancreas and metastatic breast cancer (Press release, Halozyme, OCT 22, 2018, View Source [SID1234530030]). The presentations were made at the annual European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress, taking place October 19-23 in Munich. PEGPH20 is Halozyme’s proprietary PEGylated recombinant human hyaluronidase enzyme that degrades hyaluronan (HA), a glycosaminoglycan or naturally occurring sugar in the body. HA accumulates in many solid tumors, potentially impeding the immune response and the access of anti-cancer therapies. PEGPH20 is being developed as an investigational new drug for the treatment of advanced pancreas cancer, specifically in patients with tumors that accumulate HA, referred to as HA-high.

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"These data reinforce the potential for PEGPH20 in combination with chemotherapy in these well-defined patient populations. It adds to the supportive evidence that suggests PEGPH20 could play a critical role in degrading tumor HA, allowing greater penetration of chemotherapy and improved access of the immune system into the tumor," said Dr. Helen Torley, president and chief executive officer of Halozyme. "PEGPH20 may provide a unique targeted approach for patients with late-stage cancers where new treatment options are needed."

Poster Presentations of PEGPH20 Clinical Studies at ESMO (Free ESMO Whitepaper) 2018

Abstract 5965/730P – A pilot study of gemcitabine, nab-paclitaxel, PEGPH20 and rivaroxaban for advanced pancreatic adenocarcinoma: interim safety and efficacy analysis
K. Yu, Memorial Sloan-Kettering Cancer Center, et al.

This investigator sponsored study has enrolled 60 patients with advanced pancreatic adenocarcinoma (PDAC), 42 patients without prior thromboembolic events (TE) in cohort 1 and 18 patients with prior TE in cohort 2. Patients received PEGPH20 (3 ug/kg, the same dose as is being evaluated in HALO-301), plus the standard dose and schedule for nab-paclitaxel (125 mg/m2), and gemcitabine (1000 mg/m2), plus rivaroxaban (15 mg PO BID for 21 days induction, then 20 mg PO QD), an oral anticoagulant that has been shown to reduce TE in patients receiving chemotherapy. The primary objective was the rate of symptomatic TE events, and the secondary objectives included PFS, OS and major bleeding rate.

All 60 patients are evaluable for safety and efficacy. Two (3%) grade 3/4 TE events occurred (one in each cohort), and two grade 3 GI hemorrhages; these AEs resolved with supportive treatment. There were three (5%) complete responses, 28 (47%) partial responses, 20 (33%) stable disease responses, and 9 (15%) progressive disease/non-evaluable responses. Median PFS is 7.0 months across both cohorts, and median overall survival has not been reached. Efficacy and safety are similar for patients with and without prior TE. Tissue biopsies have been collected to evaluate response by HA level but the analysis is not yet completed.

Abstract 5999/311P – Early results from an Open-label Phase 1b/2 study of eribulin mesylate (EM) + pegvorhyaluronidase alpha (PEGPH20) combination for the treatment of patients with HER2-negative, high-hyaluronan (HA) metastatic breast cancer (MBC)
M. Shum, The Oncology Institute Whittier, et al.

The Phase 1b portion of the study enrolled 14 patients with HER2 negative metastatic breast cancer without regard for HA status. Patients were treated with IV PEGPH20 plus eribulin mesylate (HALAVEN), a microtubule inhibitor approved for the treatment of metastatic breast cancer in patients previously treated with up to two lines of systemic anticancer therapy. Two different dose-levels of PEGPH20 (3ug/kg and 1.6ug/kg) were tested in combination with 1.4 mg/m2 EM. The data cut-off date for this analysis was February 2018. The median number of 21-day treatment cycles in this trial was six. No complete responses were reported, four (28.6%) patients had a partial response and three (21%) had stable disease. Drug related treatment emergent adverse events (TEAEs) occurred in 86% of patients, with 79% of patients experiencing grade 3 or higher TEAEs. There were three serious adverse events, and the overall safety profile for PEGPH20 + eribulin mesylate was in line with previous observations, with no new safety signals identified. As a result of dose limiting toxicities at the higher dose,1.6ug/kg was determined to be the appropriate dose for this combination. An additional response was confirmed following the data cutoff, increasing the overall response rate to 36%. The overall response rate is encouraging and the PEGPH20 + eribulin mesylate combination warrants further investigation.

About PEGPH20

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase enzyme under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan (HA). PEGPH20 targets and degrades hyaluronan, a glycosaminoglycan or naturally occurring sugar in the body. HA accumulates in many solid tumors, potentially constricting blood vessels, impeding the immune response and the access of anti-cancer therapies. PEGPH20 is being studied in a Phase 3 trial in patients with late stage HA-high pancreas tumors.

On October 22, 2018 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported updated preliminary results from a Phase 2 clinical trial of its lead product candidate, tipifarnib, in squamous cell carcinomas with HRAS mutations (Press release, Kura Oncology, OCT 22, 2018, View Source [SID1234530048]). The results are being presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich. A copy of the presentation is available online at www.kuraoncology.com.

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As of the September 7, 2018 clinical data cutoff date, 17 patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC) were enrolled in the ongoing Phase 2 trial. Tumor size reductions were observed in nine of 11 evaluable patients, with five confirmed partial responses (PRs) as defined by standard RECIST criteria, including three patients with durable responses lasting more than 17 months. A sixth patient achieved a confirmed PR after the data cutoff. Four patients had stable disease, including two patients who experienced prolonged disease stabilization lasting more than six months. Only one patient experienced progressive disease as best response.

Another patient with HRAS mutant HNSCC, who is currently being treated off-protocol, has been reported as an unconfirmed PR with a 40% tumor size reduction.

In addition, the ongoing Phase 2 trial enrolled six patients in an additional cohort of other HRAS mutant squamous cell carcinomas (SCCs). One of the two evaluable patients in this cohort achieved a confirmed PR. Four patients were not evaluable as of the data cutoff date, including two patients who were pending initial efficacy assessments.

An analysis of available tumor biopsy samples (n=20) indicated a significant association between the allele frequency of HRAS mutations and a patient’s best response to tipifarnib. Patients with HRAS mutant allele frequencies as low as 1% were treated with tipifarnib. Of the 13 HNSCC/SCC patients with a tumor HRAS mutant allele frequency greater than 20%, six achieved PRs, one achieved an unconfirmed PR and is ongoing, and two experienced disease stabilization greater than six months. No meaningful clinical benefit was observed in the seven patients with an allele frequency less than 20%. Data from The Cancer Genome Atlas (TCGA HNSCC, provisional) indicate that patients with an HRAS mutant allele frequency greater than 20% represent approximately 5% of the overall HNSCC population.

"The results from this study indicate that tipifarnib is active in this difficult-to-treat population, with rapid and durable responses independent of prior therapy," said Alan Ho, M.D., Ph.D., of Memorial Sloan Kettering Cancer Center and principal investigator of the study. "These data are particularly encouraging when we consider the high unmet need for patients with recurrent, metastatic head and neck squamous cell carcinomas, despite the introduction of immunotherapy into the treatment paradigm."

Response rates for the three therapies approved for treatment of HNSCC in the second line, Keytruda (pembrolizumab), Opdivo (nivolumab) and Erbitux (cetuximab), range from 13-16%, with progression-free survival of approximately two months.

Patients in the Phase 2 trial of tipifarnib in HRAS mutant HNSCC had a median of two prior lines of therapy (range 1-5), with confirmed responses observed in patients who had progressed on cetuximab regimens, immunotherapy or both.

Dose-limiting, treatment-emergent adverse events in the trial included hematological events and gastrointestinal disturbances, which were managed by dose interruption and/or dose reduction. When dose interruption/delay is taken into account, the median dose received by trial patients across all three cohorts was determined to be 600 mg twice daily by Cycle 2. Four of the responses in the trial were achieved at the 600 mg dose, including one patient who started dosing at 600 mg due to frailty and experienced a PR, and three patients who were dose-reduced to 600 mg and experienced a confirmed PR. Two additional patients achieved disease stabilization greater than six months.

Based on the observations from this Phase 2 trial, Kura intends to introduce a minimum tumor HRAS mutant allele frequency, anticipated to be no lower than 20%, as an entry criterion and use 600 mg orally twice daily as the starting dose in its upcoming AIM-HN registration-directed study of tipifarnib in HRAS mutant HNSCC. Kura also intends to implement these modifications in its ongoing Phase 2 trial and anticipates being able to provide additional data in 2019.

"We are very encouraged by the progress reported today in the treatment of patients with HRAS mutant squamous cell carcinomas," said Antonio Gualberto, M.D., Ph.D., Head of Development and Chief Medical Officer of Kura Oncology. "These data provide

preliminary clinical evidence of successful targeting of RAS-driven tumors. Notably, we observed a significant association between HRAS mutant allele frequency and objective response. We believe this finding represents a meaningful advancement in the field of precision medicine that will help our efforts to deliver on the promise of tipifarnib as a therapy for the treatment of HNSCC. We are applying these learnings to our upcoming registration-directed trial, which remains on track to initiate by year end."

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 17:00 CET / 11:00 a.m. ET today, October 22, 2018, following the conclusion of Dr. Ho’s presentation at the ESMO (Free ESMO Whitepaper) 2018 Congress. The live call may be accessed by dialing (877) 516-3514 for domestic callers or (281) 973-6129 for international callers and using conference ID #6045389. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

About Tipifarnib

Kura Oncology’s lead candidate, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown compelling and durable anti-cancer activity in certain patient subsets. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, the company is seeking to identify those patients most likely to benefit from tipifarnib. In addition to its development program in solid tumors with HRAS mutations, Kura has identified the CXCL12 pathway and bone marrow homing of myeloid cells as potential biomarkers of activity for tipifarnib in certain hematologic malignancies. The company expects to present biomarker-enriched data from peripheral T-cell lymphomas (PTCL) at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018.

On October 22, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative biopharmaceutical company, reported that the Hong Kong Department of Health has approved ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor in Hong Kong for adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian cancer who are in a complete response or partial response (CR or PR) to platinum-based chemotherapy (Press release, Zai Laboratory, OCT 22, 2018, View Source [SID1234530128]). Unlike other PARP inhibitors approved in Hong Kong, ZEJULA does not require BRCA mutation or other biomarker testing prior to administration.

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"We are now in final preparations to launch ZEJULA in Hong Kong this quarter to offer an important treatment option to ovarian cancer patients," said William Liang, Chief Commercial Officer of Zai Lab. "With the compelling clinical data, ZEJULA has the potential to save lives and have a major impact on public health. We have developed commercial and medical infrastructure in Hong Kong to educate physicians about the differentiated benefits of ZEJULA to drive its adoption. In addition, our upcoming launch is an excellent opportunity for Zai Lab to optimize best practices, as we prepare for the future launch of ZEJULA in Mainland China."

The approval of ZEJULA in Hong Kong was based upon the international Phase 3 ENGOT-OV16/NOVA trial sponsored by TESARO, Inc., a double-blind, placebo-controlled study that enrolled 553 patients with relapsed predominantly high grade serous ovarian, fallopian tube, or primary peritoneal cancer who were platinum sensitive, defined by a CR or PR for more than six months to their penultimate (next to last) platinum-based therapy. The primary endpoint of the trial was progression free survival (PFS). Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by a robust, unbiased, blinded central review to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients both with and without germline BRCA mutations as compared to the control arm. Treatment with ZEJULA reduced the risk of disease progression or death by 73% in patients with germline BRCA mutations (hazard ratio (HR) 0.27) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a CR or PR.

"Today’s approval of ZEJULA in Hong Kong represents a significant milestone for Zai Lab as it signifies our transition into a commercial stage company," said Dr. Samantha Du, Chief Executive Officer of Zai Lab. "We are grateful to the patients who participated in the clinical trials in the U.S. and Europe, the clinical investigators, our partner TESARO and our dedicated employees who collectively made this approval possible. While we are focused on making ZEJULA a commercial success in Hong Kong, we continue to drive development of ZEJULA in China, along with the rest of our broad and late-stage pipeline."

About ZL-2306

ZL-2306 (niraparib) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2inhibitor. Niraparib was approved in March 2017 by the FDA in the U.S. and by the EMA in the EU under the trade name ZEJULA in November 2017 as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the U.S. and EU, Zai Lab submitted a market registration application for niraparib in Hong Kong and expects to launch and commercialize niraparib in Hong Kong in the fourth quarter of 2018. Zai Lab believes ZL-2306 has the potential to be a first-in-class Category 1 drug for treatment across multiple solid tumor types in China.

On October 22, 2018 Genomic Health, Inc. (Nasdaq: GHDX) reported results from multiple studies of its Oncotype DX tests highlighting their value in optimizing treatment for patients with various stages of breast and prostate cancer (Press release, Genomic Health, OCT 22, 2018, View Source [SID1234530031]). The findings, presented at the ESMO (Free ESMO Whitepaper) 2018 Congress in Munich, Germany, demonstrated that the Oncotype DX tests identify patients who will or will not benefit from a specific treatment.

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Underscoring the growing international impact of the Oncotype DX Breast Recurrence Score test, two European-based studies involving patients from Ireland, France and Italy demonstrated its impact on treatment decisions for women with node-negative and node-positive breast cancer. Additionally, three prostate cancer studies in the United States demonstrated how the Oncotype DX Genomic Prostate Score (GPS) and AR-V7 Nucleus Detect tests refine treatment decisions in men with clinically low-intermediate risk or metastatic prostate cancer based on the aggressiveness of their tumor or their resistance to androgen receptor (AR)-targeted drugs.

"Oncotype DX tests have contributed to precision medicine in breast cancer for nearly 15 years, and there is now a growing body of evidence for their predictive value and clinical utility in guiding treatment selection for men with early-stage, as well as metastatic prostate cancer," said Steven Shak, M.D., chief scientific and medical officer, Genomic Health.

Oncotype DX in Node-negative and Node-positive Breast Cancer
In Ireland, researchers assessed the impact of the Oncotype DX Breast Recurrence Score on treatment decisions in routine clinical practice for early-stage breast cancer patients whose disease had spread to one to three lymph nodes (Poster #208P). Results showed that oncologists believed the test significantly changed their treatment recommendations 64 percent of the time, and that use of the Oncotype DX test led to a 27 percent reduction in recommendations for chemotherapy.

Additionally, results from a real-life, decision-impact study of breast cancer patients in France and Italy, including those with node-negative and node-positive disease, showed that treatment recommendations changed in 35 percent of patients based on their Oncotype DX test results (Poster #194P). This resulted in a 43 percent reduction in chemotherapy recommendations.

Importantly, in each country, the Oncotype DX Breast Recurrence Score result, when high, also identified the minority of patients for whom chemotherapy is potentially life-saving, highlighting the distinctive predictive value that only the Oncotype DX test delivers.

"These new results strengthen published findings from our PlanB study and show the unique value of adding genomic information provided by the Oncotype DX test to better target chemotherapy. Oncotype DX identifies patients who can safely be spared chemotherapy toxicity and side effects. Furthermore, we have to be concerned about a relevant proportion of patients who seem to be undertreated if the risk of recurrence is evaluated using only traditional clinical parameters," said Prof. Ulrike Nitz, head of the breast cancer/senology unit at the Bethesda Hospital, Moenchengladbach, Germany. "The use of the Oncotype DX test allows us to tailor treatment plans more accurately to suit the needs of individuals, and to use resources more effectively."

Oncotype DX Optimizes Treatment in Early-stage and Metastatic Prostate Cancer
Based on results from a published study, the Center for Prostatic Disease Research (CPDR) of the Uniformed Services University of the Health Sciences conducted additional analysis of the Oncotype DX Genomic Prostate Score test results in 395 men with clinically low, and intermediate-risk prostate cancer (Poster #837P). Results demonstrated that the GPS test was a significant, independent predictor of increased risk of biopsy upgrade in these patients. These data add to a separate recent independent study published by the University of California, San Francisco (UCSF) and underscore the value of the GPS test in identifying patients with more aggressive tumor biology who should be more aggressively treated at diagnosis.

The Oncotype DX GPS test is the only genomic assay designed for men at the time of diagnosis with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions based on their likelihood of adverse pathology. Developed by Genomic Health, based on results from multiple studies led by Cleveland Clinic and UCSF, the GPS test optimizes treatment by providing physicians with an assessment of both the current status (adverse pathology) and future risk (metastasis and mortality) of a patient’s cancer in making confident treatment decisions regarding active surveillance versus immediate aggressive treatment.

In metastatic prostate cancer, presentations included two studies of the Oncotype DX AR-V7 Nucleus Detect, a CTC-based, liquid biopsy test that helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant, or not, to AR-targeted therapies, such as enzalutamide and abiraterone, and which patients may benefit from chemotherapy. The Oncotype DX AR-V7 Nucleus Detect test is commercially available in the United States through Epic Science’s collaboration with Genomic Health.

A new analysis, combining data from two published studies, confirmed that the Oncotype DX AR-V7 Nucleus Detect test for AR-V7 protein is a predictive biomarker for identifying patients who will not respond to additional AR-targeted therapy (Poster #848P). These data further support that detection of nuclear-localized AR-V7-positive circulating tumor cells (CTCs) by the Oncotype DX test indicates that the patient will not benefit from additional treatment with commonly-prescribed AR-targeted therapy and should consider switching to an alternative therapy to increase survival.

Separately, an independent study of the Oncotype DX AR-V7 Nucleus Detect test conducted by Epic Sciences in collaboration with its academic partners confirmed that the use of AR-V7 optimizes therapy guidance over risk assessment alone (Poster #836P).

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to AR-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 900,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatement.org.