On August 25, 2016Medtronic plc (NYSE: MDT) reported financial results for its first quarter of fiscal year 2017, which ended July 29, 2016 (Press release, Medtronic, AUG 25, 2016, View Source;p=RssLanding&cat=news&id=2197342 [SID:1234514731]).

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The company reported first quarter worldwide revenue of $7.166 billion, a decrease of 1 percent, or an increase greater than 5 percent on a constant currency, constant weeks (CCCW) basis. Foreign currency translation had a negative $7 million impact on revenue. The first quarter of fiscal year 2017 contained 13 weeks, one less week than the first quarter of fiscal year 2016. The extra week occurs every six years as a result of the company’s 52-53 week fiscal year calendar. While it is difficult to calculate an exact impact from the extra week, the company estimates that it resulted in an approximate $450 million benefit to revenue and $0.08 to $0.10 benefit to non-GAAP diluted earnings per share (EPS) in the first quarter of the prior fiscal year.
First quarter GAAP net income and diluted EPS were $929 million and $0.66, increases of 13 percent and 16 percent, respectively. As detailed in the financial schedules included through the link at the end of this release, first quarter non-GAAP net income and diluted EPS were $1.444 billion and $1.03, representing increases of approximately 11 to 14 percent and approximately 14 to 16 percent, respectively, on a CCCW basis.
U.S. revenue of $4.002 billion represented 56 percent of company revenue and decreased 3 percent, or increased in the low-single digits on a constant weeks basis. Non-U.S. developed market revenue of $2.231 billion represented 31 percent of company revenue and increased 2 percent, or increased in the mid-single digits on a CCCW basis. Emerging market revenue of $933 million represented 13 percent of company revenue and was flat, or increased in the low-double digits on a CCCW basis.
"Q1 was another strong quarter for Medtronic, where our diversified businesses and geographies delivered solid results," said Omar Ishrak, Medtronic chairman and chief executive officer. "In addition to our solid top- and bottom-line performance, we also continue to generate significant free cash flow, and we continue to strategically deploy our capital against our priorities of reinvesting with discipline in M&A and R&D, returning substantial cash to our shareholders, and deleveraging our balance sheet."
Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide revenue of $2.518 billion decreased 2 percent, or increased in the mid-single digits on a CCCW basis, driven by strong, balanced growth across all three divisions.
CRHF revenue of $1.334 billion decreased 3 percent, or increased in the mid-single digits on a CCCW basis. The division outperformed the market in core implantables on the strength of the Amplia MRI(TM) and Compia MRI(TM) Quad CRT-D, Evera MRI ICD, and Micra TPS pacemaker. AF Solutions grew in the mid-thirties on a CCCW basis on the strength of the Arctic Front Advance cryoballoon and recent FIRE AND ICE clinical data. The Diagnostics business also had a solid quarter, growing in the low-double digits on a CCCW basis, on the continued global adoption of the Reveal LINQ insertable cardiac monitor.
CSH revenue of $762 million decreased 3 percent, or increased in the mid-single digits on a CCCW basis, driven by high-twenties growth on a CCCW basis in transcatheter aortic heart valves as a result of strong customer adoption of the CoreValve Evolut R. Coronary declined in the mid-single digits on a CCCW basis, but drug-eluting stents grew in the mid-single digits on a CCCW basis in markets outside the United States driven by Resolute Onyx(TM) in Europe and emerging markets.
APV revenue of $422 million increased 2 percent, or increased in the high-single digits on a CCCW basis, with high-single digit growth on a CCCW basis in the Aortic business, driven by the continued strength of the Endurant IIs aortic stent graft, the Heli-FX EndoAnchor System, and Valiant Captivia thoracic stent graft. The Peripheral Vascular business grew in the high-single digits on a CCCW basis, with strong above-market growth in drug-coated balloons, driven by the clinically differentiated IN.PACT Admiral DCB, which holds the leading market position in the U.S. and globally.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Solutions and the Patient Monitoring & Recovery (PMR) divisions. MITG worldwide revenue of $2.424 billion decreased 1 percent, or increased in the mid-single digits on a CCCW basis, another strong quarter for the group with above market growth.
Surgical Solutions revenue of $1.348 billion was flat, or increased in the mid-single digits on a CCCW basis, driven by high-single digit growth on a CCCW basis in Advanced Stapling and mid-single digit growth on a CCCW basis in Advanced Energy. Early Technologies grew in the high-single digits on a CCCW basis, led by strong growth in GI Solutions.
PMR revenue of $1.076 billion decreased 3 percent, or increased in the mid-single digits on a CCCW basis, driven by growth in Renal Care Solutions from the recent acquisition of Bellco. The division also returned to market with the Puritan Bennett(TM) 980 ventilator and Capnostream(TM) 20 capnography monitor, which had previously been under shipping holds.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. This is the first quarter RTG revenue is reported in its new four division structure. RTG worldwide revenue of $1.772 billion decreased 2 percent, or increased in the mid-single digits on a CCCW basis. Group results were driven by strong Brain Therapies and Specialty Therapies growth, as well as by continued improvement in U.S. Spine, offsetting declines in Pain Therapies, all on a CCCW basis.
In the Spine division, which now includes the Core Spine, BMP, and Kanghui businesses, revenue of $645 million decreased 6 percent, or was flat on a CCCW basis. The Core Spine business grew in the low-single digits in the U.S. on a constant weeks basis, in-line with the market, as a number of new products and focus on procedural innovation is driving improved results. BMP grew in the mid-single digits on a CCCW basis, with high-single digit growth in the U.S. on a constant weeks basis partially offset by the continued loss of InductOs(TM) sales in Europe as a result of a shipping hold.
In the Brain Therapies division, which now includes the Neurovascular, Brain Modulation, and Neurosurgery businesses, revenue of $489 million increased 6 percent, or increased in the low-double digits on a CCCW basis. All three businesses had strong quarters, with Neurovascular growing in the high-teens, Neurosurgery growing in the low-double digits, and Brain Modulation growing in the mid-single digits, all on a CCCW basis.
In the Specialty Therapies division, which now includes the Pelvic Health, Advanced Energy, and ENT businesses, revenue of $356 million increased 3 percent, or increased in the low-double digits on a CCCW basis. All three businesses delivered strong quarters, with Advanced Energy growing in the high-teens, and Pelvic Health and ENT both growing in the high-single digits, all on a CCCW basis.
In the Pain Therapies division, which now includes the Pain (Spinal Cord Stimulation and Drug Pumps) and Interventional Spine businesses, revenue of $282 million decreased 9 percent, or decreased in the low-single digits on a CCCW basis. After adjusting for the divestiture of our drug business, which occurred in the third quarter of fiscal year 2016, Pain Therapies revenue was flat on a CCCW basis. Spinal Cord Stimulation declined in the mid-single digits on a CCCW basis, as the business faced competitive pressures. Drug Pumps grew in the mid-single digits on a CCCW basis, as the business returned to growth following declines over the past year as a result of its April 2015 U.S. FDA consent decree. Interventional Spine grew in the low-single digits on a CCCW basis.
Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide revenue of $452 million increased 2 percent, or increased in the high-single digits on a CCCW basis. The group had strong, broad-based performance across all three divisions.
IIM grew in the high-single digits on a CCCW basis, driven by continued strong sales in Europe and Asia Pacific of the MiniMed 640G System with the enhanced Enlite sensor and SmartGuard(TM) technology.
NDT grew in the mid-seventies on a CCCW basis, led by strong U.S. sales of the iPro2 Professional Continuous Glucose Monitor (CGM) technology with Pattern Snapshot.
DSS grew in the high-single digits on a CCCW basis as a result of solid growth of consumables, revenue from the company’s acquisition of Diabeter in Europe, and continued strong growth of the MiniMed Connect, which over 18,000 people with diabetes are now using to view their insulin pump and CGM information on a smartphone.
Revenue Outlook and EPS Guidance
The company today reiterated its fiscal year 2017 revenue outlook and EPS guidance. Consistent with the company’s long-term, mid-single digit constant currency revenue growth expectation, the company continues to expect fiscal year 2017 revenue growth to be in the range of 5 to 6 percent on a CCCW basis, which excludes the benefit of the extra selling week in the company’s first quarter of fiscal year 2016, as well as the estimated benefit from foreign currency in fiscal year 2017.
In addition, the company reiterated its diluted non-GAAP EPS guidance for fiscal year 2017. The company expects fiscal year 2017 diluted non-GAAP EPS growth in the range of 12 to 16 percent on a CCCW basis, which excludes the estimated negative impact of foreign currency translation, as well as the benefit from the extra selling week in the company’s first quarter of fiscal year 2016. This annual EPS growth range is consistent with the company’s long-term, double digit constant currency EPS growth expectation, and continues to imply fiscal year 2017 diluted non-GAAP EPS in the range of $4.60 to $4.70. Other than as noted, EPS guidance does not include charges or gains that would be recorded as non-GAAP adjustments to earnings during the fiscal year.
"We feel very good about our momentum to start our fiscal year, and we are confident in our ability to sustain this performance over the coming quarters," said Ishrak. "We also remain focused on fully understanding and leading the shift to value-based healthcare systems that reward value and patient outcomes over volume, and we continue to develop partnerships and insights into how we can utilize our expertise to play a role in this evolution. We feel the appropriate application of medical technology can help address inefficiencies and improve outcomes in healthcare delivery, driving new forms of value creation – for both our customers and our shareholders."

On August 25, 2013, Soligenix, Inc. (the "Company") reported it entered into an agreement with SciClone Pharmaceuticals, Inc. ("SciClone"), pursuant to which SciClone provided the Company with access to its oral mucositis clinical and regulatory data library in exchange for exclusive commercialization rights for SGX942 (dusquetide), a novel, first-in-class therapy being developed by the Company for the treatment of oral mucositis in patients with head and neck cancer, subject to the negotiation of economic terms (Filing, 8-K, Soligenix, AUG 25, 2016, View Source [SID:SID1234515114]).

On September 9, 2016, the Company and SciClone entered into an exclusive license agreement (the "License Agreement"), pursuant to which the Company granted rights to SciClone to develop, promote, market, distribute and sell SGX942 in the People’s Republic of China, including Hong Kong and Macau, as well as Taiwan, South Korea and Vietnam (the "Territory"). Under the terms of the License Agreement, SciClone will be responsible for all aspects of development, product registration and commercialization in the Territory, having access to data generated by the Company. In exchange for exclusive rights, SciClone will pay to the Company royalties on net sales, and the Company will supply commercial drug product to SciClone on a cost-plus basis, while maintaining worldwide manufacturing rights.

In connection with the execution of the License Agreement, the Company entered into a common stock purchase agreement (the "Purchase Agreement") with SciClone pursuant to which the Company sold 3,529,412 shares of the Company’s common stock, par value $0.001 per share ("Common Stock"), to SciClone for $0.85 per share, for an aggregate price of $3,000,000. As additional consideration for expanded territorial rights in South Korea, Taiwan and Vietnam, SciClone agreed to purchase the shares of Common Stock at a premium above the current market price, with the purchase price being equal to one hundred thirty five percent (135%) of the average trading price of the Common Stock over the ten trading days prior to September 9, 2016. As part of the transaction, the Company granted SciClone certain demand registration rights.

The Purchase Agreement is provided to give investors information regarding the agreements’ respective terms. It is not provided to give investors factual information about the Company or SciClone. In addition, the representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of that agreement and as of specific dates, were solely for the benefit of the parties to that agreement, and may be subject to limitations agreed by the contracting parties, including being qualified by disclosures exchanged between the parties in connection with the execution of such agreement. The representations and warranties may have been made for the purposes of allocating contractual risk between the parties to the agreement instead of establishing these matters as facts, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under the agreement and should not view the representations, warranties and covenants or any descriptions thereof as characterizations of the actual state of facts or conditions of the Company.

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On August 24, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported its participation in four upcoming investor conferences (Press release, TESARO, AUG 24, 2016, View Source [SID:1234514709]). The four conferences are:

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The Wells Fargo Global Healthcare Conference at the Westin Boston Waterfront in Boston on Wednesday, September 7. Lonnie Moulder, CEO of TESARO, and Mary Lynne Hedley, Ph.D., President and COO of TESARO, will participate in an analyst-led moderated Q&A from 3:30 to 4:00 PM ET and in meetings with investors.

The 11th Annual Citi Biotech Day at the Mandarin Oriental Hotel in Boston on Thursday, September 8, 2016. Lonnie Moulder will participate in a panel titled "Developing Cancer Therapeutics in 2016" at 8:00 AM ET. Also, Lonnie Moulder and Mary Lynne Hedley, Ph.D. will host meetings with investors.

The Baird 2016 Healthcare Conference at the New York Palace Hotel in New York City on Thursday, September 8. Tim Pearson, EVP and CFO of TESARO, is scheduled to participate in an analyst-led fireside chat from 12:15 to 12:45 PM ET, and in meetings with investors.

The Leerink Partners Roundtable Series: Rare Disease & Immuno-Oncology at the Lotte New York Palace in New York City on September 29, 2016. Lonnie Moulder and Jeff Hanke, Ph.D., EVP and Chief Scientific Officer of TESARO, will participate in an analyst-led fireside chat from 1:00 to 1:30 PM ET, and in meetings with investors.

On August 24, 2016 Cantargia AB ("Cantargia") reported its interim report for January – June 2016 is available on the company website (www.cantargia.com/Investors/Reports) (Press release, Cantargia, AUG 24, 2016, View Source [SID:1234514711]).

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Significant events in the second quarter

· The exercise period for warrants of series TO 1 and TO 3 began on 23 March 2016 and ended on 13 April 2016. In total, 4,127,260 warrants of both series were exercised, representing around 83.5 per cent of the number of warrants issued. Through the warrants Cantargia raised approximately SEK 31.4 million before issue costs.

· During the period the Company gave investor presentations at the international BioEquity conference in Copenhagen on 10 May 2016 and at the Småbolagsdagen small cap investor event at the Sheraton Stockholm Hotel on 13 June 2016.

· The annual report for the financial year 2015 was published on 29 April 2016. The company held its Annual General Meeting on 25 May 2016 and published a report on the AGM the following day. The annual report and AGM report are available for download on the company’s website, www.cantargia.com.

· Cantargia received a Notice of Allowance from the US Patent Office for IL1RAP as target molecule for antibody-based treatment in acute lymphoblastic leukemia followed by a Notice of Allowance for IL1RAP as target molecule for antibody-based treatment in solid tumours from the same patent office. The company also received formal approval in Japan of a patent for solid tumours.

· The company announced that its CAN04 product candidate has been shown to have a high level safety in high doses – repeated treatment with up to 100 mg/kg. During the period Cantargia also decided that the company will conduct further process development studies to establish a strong foundation for long-term production and that the start of the GLP toxicity study will therefore be postponed until autumn 2016. Consequently, the start of clinical studies will also be postponed until the end of the first quarter of 2017.

· A third party filed an opposition to Cantargia’s patent in Europe for IL1RAP as a target molecule for antibody treatment and leukemia diagnostics. Cantargia will be working with its patent agents and the European Patent Office to conduct the process in a professional and correct manner.

Significant events after the end of the period

· In July Cantargia announced that the US Patent Office had approved the company’s application for IL1RAP as target molecule for antibody-based treatment of solid tumours.

· In August Cantargia announced that the company’s former CEO, Agneta Svedberg, has exercised 1,250 warrants of series 2011/2016. The exercise of the warrants will raise SEK 250,212.50 for Cantargia.

Financial information

First half (1 Jan 2016 – 30 Jun 2016)

· Other operating revenue was kSEK 0 (0).

· Earnings after financial items were kSEK -16,023 (-9,059).

· Earnings per share were approximately SEK -0.91 (-0.68).

· The equity/assets ratio was around 87 (89) per cent compared with the beginning of the year.

Second quarter (1 Apr 2016 – 30 Jun 2016)

· Other operating revenue was kSEK 0 (0).

· Earnings after financial items were kSEK -7,926 (-5,432).

· Earnings per share were approximately SEK -0.45 (-0.41).

Definitions

· Earnings per share: Profit for the period divided by 17,633,134 shares as at 30 June 2016.

· Equity/assets ratio: Equity divided by total capital.

· Unless otherwise indicated, figures in parentheses refer the same period in the previous year.

This constitutes information that Cantargia is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person at 8:30 (CEST) on August 24, 2016.

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On August 24, 2016 Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, reported the peer-reviewed publication of the primary outcome results of the Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) clinical trial in the prestigious New England Journal of Medicine (NEJM) (Press release, Agendia, AUG 24, 2016, View Source [SID:1234514712]). [i, iii, iv] The publication demonstrates that 46% of breast cancer patients considered for chemotherapy, whose tumors are classified MammaPrint Low Risk, have excellent survival without chemotherapy, and can thus be candidates to avoid this toxic therapy. [i, pg. 717]

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MINDACT is a collaboration between Agendia, the European Organization for Research and Treatment of Cancer (EORTC) and the Breast International Group (BIG). A unique phase III prospective, randomized, controlled study of 6,693 patients across 112 European cancer centers, MINDACT provides the highest level of clinical evidence (Level 1A) and confirms the clinical utility of using Agendia’s MammaPrint 70-gene breast cancer recurrence assay to help predict clinical outcome in women with early-stage breast cancer.

"When we developed MammaPrint, we knew we wanted to achieve the same level of evidence required for a typical pharmaceutical drug. That is why we are one of only a few diagnostic tests with FDA clearance and why we rigorously evaluated MammaPrint in the context of clinical-pathological factors in the randomized MINDACT trial," said Prof. Laura van ’t Veer, Chief Research Officer at Agendia, and Leader, Breast Oncology Program, and Director, Applied Genomics at UCSF Helen Diller Family Comprehensive Cancer Center. "Now indeed, we have the only genomic assay with Level 1A evidence to help physicians more accurately predict risk of distant metastasis in patients with early-stage breast cancer."

MINDACT is the first prospective translational clinical study of this magnitude in early-stage breast cancer to report the results of its primary objective and publish them in a peer-reviewed journal. At 5 years, patients who did not receive adjuvant chemotherapy but were classified as being at high risk for breast cancer recurrence based on clinical-pathological factors and as being at Low Risk based on MammaPrint, had similar rates of disease free survival. [i, pg. 717]

"The design of the MINDACT trial proves the clinical utility of the MammaPrint assay," said Dr. Gabriel Hortobagyi, MD, FACP, FASCO Professor and Chair Emeritus of the Department of Breast Medical Oncology at the MD Anderson Cancer Center (MDACC) and Chair of the Agendia Inc. Medical Advisory Board. "The reporting of these conclusive results of the trial will now give physicians increased confidence that in using MammaPrint, their treatment decisions will be based on the highest level of clinical evidence and will minimize the incidence of over- or under-treatment."

"We understand that a risk–benefit assessment and decisions with respect to the use of adjuvant chemotherapy are highly variable and personalized among physicians and individual patients. However, these findings provide clinical utility by demonstrating that MammaPrint’s accuracy in helping to detect patients with a low risk of distant recurrence could be safely used in the management of over one hundred thousand[ii] women and potentially spare them from unnecessary chemotherapy," said Dr. William Audeh, Chief Medical Officer at Agendia. "The toxicities and side effects of chemotherapy may outweigh the potentially small and non-statistically significant benefit (1.5% 95% CI, 0.50 to 1.21; p = 0.27) of chemotherapy in women at high risk based on clinical factors but at Low Risk per MammaPrint. Thus, physicians and breast cancer patients may on an individual basis decide to avoid it."

In MINDACT, when the authors looked at the patients with the most common type of breast cancer, hormone receptor positive, human epidermal growth factor receptor 2 negative, and lymph node negative (HR+/HER2-/LN0) disease, 75% were identified as having a Low Risk of recurrence using MammaPrint. The Distant Metastasis Free Interval (DMFI) for these patients (which according to the researchers is the optimal endpoint to evaluate a genomic assay that looks at prognosis and benefit of chemotherapy treatment) was 97.8% without chemotherapy. [i, supplement pg. 12-13]

In MINDACT, this MammaPrint Low Risk group of breast cancer patients who may be candidates to forgo chemotherapy is over four times larger than the proportion identified with a low-Recurrence Score (RS) in both TAILORx.[v] and Plan B.[vi]. The TAILORx trial, which is the trial that would validate the appropriate cut-offs for the Oncotype DX 21-gene breast cancer recurrence assay, has only reported data on the low risk arm of the study that included 15% of the patients who are in the non-randomized arm of patients with RS 10 and under. The TAILORx trial, has not presented results of its primary objective of the outcome of patients with RS between 11-25.

"MINDACT provides us with the highest level of evidence to support what we at Agendia have always believed, that MammaPrint is a definitive, accurate and clinically relevant breast cancer recurrence assay. The quality of life and cost efficiency implications of helping physicians choose the appropriate management for women with breast cancer is the reason we do what we do every day," commented Mark Straley, Chief Executive Officer, Agendia. "We understand that ultimately, the decision to receive or forgo chemotherapy lies with each patient and physician who is properly informed about the potential side effects and benefits of such treatment. Nonetheless, MammaPrint could potentially change the standard of care and we look forward to its recommendation for inclusion in all early-stage breast cancer management guidelines. This will ensure that even more patients, physicians and healthcare systems are aware of the benefits of MammaPrint-based management decisions."

Breast cancer is the most frequently diagnosed cancer in women worldwide.[vii] In 2012, there were nearly 1.7 million new breast cancer cases among women worldwide, accounting for 25% of all new cancer cases in women.[viii] MINDACT initial results were selected for a prestigious breakthrough presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2016, 16-20 April.

For more information on the MINDACT trial publication, please visit the Agendia newsroom: View Source

[i] Cardosa F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
[ii] Based on applying MINDACT risk data to: American Cancer Society. Global Cancer Facts & Figures 3rd Edition. Atlanta: American Cancer Society; 2015. (online) and American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta: American Cancer Society, Inc. 2015.
[iii] Hudis CA, Dickler, M. Increasing Precision in Adjuvant Therapy for Breast Cancer. N Engl J Med 2016; 375: 790-91.
[iv] For disclosures regarding involvement in trial, see page 728 of publication (Cardosa F. NEJM 2016) mentioned above.
[v] Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med 2015; 373: 2005-14.
[vi] Gluz O, Nitz, U. A., Matthias, C, et al. West German Study Group Phase III Plan B Trial: First Prospective Outcome Data for the 21-Gene Recurrence Score Assay and Concordance of Prognostic Markers by Central and Local Pathology Assessment. J Clin Oncol 2016; 34(20):2341-9
[vii] World Health Organization. Breast cancer: prevention and control. Website. View Source Accessed March 2016.
[viii] American Cancer Society. Global Cancer Facts & Figures 3rd Edition. Atlanta: American Cancer Society; 2015. (online)

About MINDACT
MINDACT is a prospective, randomized, phase III, controlled clinical trial that investigates the clinical utility of MammaPrint, when used in conjunction with standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy. From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer enrolled in the trial, across 112 centers in nine countries. Patients were categorized as low or high risk for tumor recurrence in two ways: first, through analysis of tumor tissue using MammaPrint; and second, using Adjuvant! Online, a tool that calculates risk of breast cancer recurrence based on common clinical pathological factors. Patients characterized in both clinical and genomic assessments as low risk are spared chemotherapy, while patients characterized as high risk are advised chemotherapy. Those with discordant results were randomized to use either clinical or genomic risk (MammaPrint) evaluation for chemotherapy treatment.
MINDACT is a population based trial. A risk–benefit assessment and decisions with respect to the use of chemotherapy are highly variable among physicians and patients, and even national and international guidelines differ in their recommendations. Ultimately, the decision to receive or forgo chemotherapy (or any other treatment) lies with each patient who is properly informed about the potential side effects and the potential benefits of such treatment. For the same risk–benefit scenario, different patients may make different decisions. [i, pg. 727-28]

About MammaPrint
MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine.