On October 19, 2016 Abbott (NYSE: ABT) financial results for the third quarter ended Sept. 30, 2016 (Press release, Abbott, OCT 19, 2016, View Source [SID1234515913]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Third-quarter worldwide sales of $5.3 billion increased 2.9 percent on a reported basis and 4.0 percent on an operational basis.
Reported diluted EPS from continuing operations under GAAP was a $(0.24) loss in the third quarter, primarily due to an adjustment of $(0.66) per share associated with Abbott’s equity investment in Mylan to reflect Mylan’s share price as of Sept. 30, 2016. Excluding specified items, adjusted diluted EPS from continuing operations was $0.59 in the third quarter, at the high end of the previous guidance range.

Abbott adjusted its full-year 2016 EPS guidance for continuing operations under GAAP to $0.59 to $0.61, and narrowed and raised at the mid-point its full-year 2016 adjusted EPS for continuing operations to $2.19 to $2.21, exceeding its initial guidance for the year.

In the third quarter, Abbott received U.S. FDA approval for its FreeStyle Libre Pro system, a revolutionary continuous glucose monitoring system for healthcare professionals to use with their patients with diabetes; submitted for U.S. regulatory approval a consumer version of FreeStyle Libre, to be used by people with diabetes to self-monitor glucose levels; received U.S. FDA approval for AbsorbTM, the only fully dissolving heart stent; and received U.S. FDA approval for TECNIS Symfony intraocular lenses for the treatment of cataracts, the first and only extended depth of focus lenses for people with cataracts.

On Sept. 16, 2016, Abbott announced the sale of Abbott Medical Optics, its vision care business, to Johnson & Johnson for $4.325 billion. This transaction aligns with Abbott’s shaping of its portfolio, which has recently focused on developing leadership positions in cardiovascular devices and expanding diagnostics. The transaction is expected to close in the first quarter of 2017 and is subject to customary closing conditions, including regulatory approvals.

"Strong performance in Established Pharmaceuticals and Medical Devices led our sales growth this quarter," said Miles D. White, chairman and chief executive officer, Abbott. "We’re on track to deliver the financial commitments we set at the beginning of the year. We also had several key product launches and continued to take strategic actions to shape our business for long-term growth."

THIRD-QUARTER BUSINESS OVERVIEW

Following are sales by business segment and commentary for the third quarter and the first nine months of the year:

Total Company
($ in millions)

% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total *
1,645

3,657

5,302

4.5

2.2

3.7

2.9

4.0

Nutrition
755

1,000

1,755

3.5

(5.7)

(4.1)

(2.0)

(1.0)

Diagnostics
362

851

1,213

4.1

5.3

6.0

5.0

5.4

Established Pharmaceuticals
—

1,012

1,012

n/a

5.3

9.0

5.3

9.0

Medical Devices
519

791

1,310

6.0

6.7

6.1

6.4

6.0

* Total Abbott Sales from continuing operations include Other Sales of $12 million.

% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total *
4,831

10,689

15,520

3.5

1.3

5.9

2.0

5.2
Nutrition
2,224

2,942

5,166

3.8

(3.0)

1.6

(0.2)

2.5
Diagnostics
1,062

2,495

3,557

3.6

3.9

7.1

3.8

6.1
Established Pharmaceuticals
—

2,880

2,880

n/a

1.6

9.8

1.6

9.8
Medical Devices
1,520

2,359

3,879

2.8

4.1

5.6

3.6

4.5

* Total Abbott Sales from continuing operations include Other Sales of $38 million.
n/a = Not Applicable.
Note: Operational growth reflects percentage change over the prior year excluding the impact of exchange rates. In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third-quarter 2016 worldwide sales of $5.3 billion increased 2.9 percent on a reported basis, including an unfavorable 1.1 percent effect of foreign exchange, and increased 4.0 percent on an operational basis. Excluding the impact of Venezuelan operations, sales would have increased 4.5 percent on a reported basis and 5.6 percent on an operational basis.

International sales increased 2.2 percent on a reported basis and 3.7 percent on an operational basis in the third quarter. International operational growth was led by strong performance across Established Pharmaceuticals, Diagnostics and Medical Devices.

Nutrition
($ in millions)

% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
755

1,000

1,755

3.5

(5.7)

(4.1)

(2.0)

(1.0)
Pediatric
414

553

967

4.3

(9.4)

(7.5)

(4.0)

(2.8)
Adult
341

447

788

2.6

(0.8)

0.6

0.6

1.4



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
2,224

2,942

5,166

3.8

(3.0)

1.6

(0.2)

2.5
Pediatric
1,242

1,664

2,906

5.0

(5.1)

(0.7)

(1.0)

1.6
Adult
982

1,278

2,260

2.3

(0.1)

4.7

0.9

3.7

Worldwide Nutrition sales decreased 2.0 percent on a reported basis in the third quarter, including an unfavorable 1.0 percent effect of foreign exchange, and decreased 1.0 percent on an operational basis.

Worldwide Pediatric Nutrition sales decreased 4.0 percent on a reported basis in the third quarter, including an unfavorable 1.2 percent effect of foreign exchange, and decreased 2.8 percent on an operational basis. During the quarter, Abbott introduced Similac Pro-Advance and Similac Pro-Sensitive, the first infant formulas in the U.S. with a human milk oligosaccharide that offers a unique immune-nourishing prebiotic. International sales declined 9.4 percent on a reported basis and 7.5 percent on an operational basis, driven by challenging market conditions in China, partially offset by continued strong performance in Latin America and Southeast Asia.

Worldwide Adult Nutrition sales increased 0.6 percent on a reported basis in the third quarter, including an unfavorable 0.8 percent effect of foreign exchange, and increased 1.4 percent on an operational basis. Operational sales growth in the quarter was led by growth of Ensure, Abbott’s complete and balanced nutrition brand.

Diagnostics
($ in millions)

% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
362

851

1,213

4.1

5.3

6.0

5.0

5.4
Core Laboratory
220

757

977

7.6

5.0

5.7

5.6

6.1
Molecular
42

70

112

(9.6)

5.4

6.3

(0.8)

(0.3)
Point of Care
100

24

124

3.4

15.6

14.1

5.6

5.3



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
1,062

2,495

3,557

3.6

3.9

7.1

3.8

6.1
Core Laboratory
616

2,224

2,840

3.4

3.8

7.1

3.7

6.3
Molecular
140

199

339

(3.4)

1.9

5.2

(0.3)

1.5
Point of Care
306

72

378

7.6

13.3

13.6

8.6

8.7

Worldwide Diagnostics sales increased 5.0 percent on a reported basis in the third quarter, including an unfavorable 0.4 percent effect of foreign exchange, and increased 5.4 percent on an operational basis. During the quarter, Abbott unveiled its new suite of diagnostic instruments, AlinityTM, at the American Association for Clinical Chemistry conference. The Alinity suite includes new instruments for every area of the diagnostics market where Abbott competes and incorporates features deemed important to customers, including increased automation, higher volumes, faster results, smaller size and an improved user interface.

Core Laboratory Diagnostics sales increased 5.6 percent on a reported basis in the third quarter, including an unfavorable 0.5 percent effect of foreign exchange, and increased 6.1 percent on an operational basis. Operational sales growth in the quarter was led by continued share gains in the U.S. and internationally.

Molecular Diagnostics sales decreased 0.8 percent on a reported basis in the third quarter, including an unfavorable 0.5 percent effect of foreign exchange, and decreased 0.3 percent on an operational basis. As expected, continued strong growth in Abbott’s infectious disease testing business was offset primarily by the planned scale down of its genetics business.

Point of Care Diagnostics sales increased 5.6 percent on a reported basis in the third quarter, including a favorable 0.3 percent effect of foreign exchange, and increased 5.3 percent on an operational basis. Sales growth was led by continued adoption of Abbott’s i-STAT handheld system in the U.S. and international markets.

Established Pharmaceuticals
($ in millions)

% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
—

1,012

1,012

n/a

5.3

9.0

5.3

9.0
Key Emerging Markets
—

747

747

n/a

7.0

12.2

7.0

12.2
Other
—

265

265

n/a

0.7

0.6

0.7

0.6



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
—

2,880

2,880

n/a

1.6

9.8

1.6

9.8
Key Emerging Markets
—

2,135

2,135

n/a

2.7

13.4

2.7

13.4
Other
—

745

745

n/a

(1.5)

—

(1.5)

—

Established Pharmaceuticals sales increased 5.3 percent on a reported basis in the third quarter, including an unfavorable 3.7 percent effect of foreign exchange, and increased 9.0 percent on an operational basis.

Key Emerging Markets include India, Russia, Brazil and China, along with several additional emerging markets that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these key geographies increased 7.0 percent on a reported basis and 12.2 percent on an operational basis. Operational sales growth was led by continued strong growth in India, which comprises more than 20 percent of Abbott’s Established Pharmaceuticals sales, as well as above-market growth in several countries throughout Latin America driven by commercial initiatives and locally relevant portfolio expansion.

Medical Devices
($ in millions)

% Change vs. 3Q15

Sales 3Q16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
519

791

1,310

6.0

6.7

6.1

6.4

6.0
Vascular
305

403

708

9.8

2.0

1.4

5.2

4.9
Diabetes Care
96

210

306

(2.2)

19.1

20.7

11.5

12.5
Medical Optics
118

178

296

3.7

4.8

1.7

4.4

2.5

Vascular Product Lines:

Coronary Devicesa)
201

336

537

4.8

—

(0.8)

1.8

1.2
Endovascularb)
76

66

142

4.6

13.7

14.3

8.6

8.9

a) Includes DES / BVS product portfolio, structural heart, guidewires, balloon catheters and other coronary products.
b) Includes vessel closure, carotid stents and other peripheral products.



% Change vs. 9M15

Sales 9M16

Int’l

Total

U.S.

Int’l

Total

U.S.

Reported

Operational

Reported

Operational
Total
1,520

2,359

3,879

2.8

4.1

5.6

3.6

4.5
Vascular
940

1,235

2,175

9.5

0.1

1.8

3.9

4.9
Diabetes Care
238

594

832

(18.6)

12.6

15.7

1.5

3.5
Medical Optics
342

530

872

4.2

4.9

4.6

4.6

4.4

Vascular Product Lines:

Coronary Devicesa)
597

1,039

1,636

4.5

(1.5)

—

0.6

1.6
Endovascularb)
226

194

420

7.5

9.0

11.7

8.2

9.4

a) Includes DES / BVS product portfolio, structural heart, guidewires, balloon catheters and other coronary products.
b) Includes vessel closure, carotid stents and other peripheral products.

Worldwide Medical Devices sales increased 6.4 percent on a reported basis in the third quarter, including a favorable 0.4 percent effect of foreign exchange, and increased 6.0 percent on an operational basis.

Worldwide sales of Vascular products increased 5.2 percent on a reported basis in the third quarter, including a favorable 0.3 percent effect of foreign exchange, and increased 4.9 percent on an operational basis. Sales growth in Vascular products was led by double-digit growth of MitraClip, Abbott’s device for the treatment of mitral regurgitation, as Abbott continues to build the market for this first-in-class device. Strong sales growth in Abbott’s Endovascular business was driven by vessel closure products and Supera, Abbott’s unique stent for the treatment of blockages in the leg. In the quarter, Abbott received U.S. FDA approval for Absorb, the only fully dissolving heart stent.

Worldwide Diabetes Care sales increased 11.5 percent on a reported basis in the third quarter, including an unfavorable 1.0 percent effect of foreign exchange, and increased 12.5 percent on an operational basis. International sales growth was driven by continued consumer uptake of FreeStyle Libre, Abbott’s revolutionary continuous glucose monitoring system that eliminates the need for finger-sticks. In September, Abbott received U.S. FDA approval for the FreeStyle Libre Pro system, which is designed to help healthcare professionals make better, customized treatment decisions for their patients – and at a significantly lower cost than other professional continuous glucose monitoring systems. During the quarter, Abbott submitted the consumer version of the FreeStyle Libre system for review by the U.S. FDA. The consumer version of the FreeStyle Libre system is designed to eliminate the need for routine finger-sticks and provides glucose data in a simple format that allows people with diabetes to better self-monitor their glucose levels.

Worldwide Medical Optics sales increased 4.4 percent on a reported basis in the third quarter, including a favorable 1.9 percent effect of foreign exchange, and increased 2.5 percent on an operational basis. Operational sales growth was driven by continued market uptake of cataract products in the premium intraocular lens segment. In the quarter, Abbott received U.S. FDA approval and launched its TECNIS Symfony intraocular lenses, the first and only lenses in the U.S. that provide a full range of continuous high-quality vision following cataract surgery.

ABBOTT NARROWS ITS FULL-YEAR EARNINGS-PER-SHARE GUIDANCE

Abbott is adjusting its projected earnings per share from continuing operations under Generally Accepted Accounting Principles (GAAP) to $0.59 to $0.61 for the full year 2016.

Abbott forecasts net specified items for the full year 2016 of approximately $1.60 per share. Specified items include intangible amortization expense, the impact of the Venezuelan currency devaluation in the first quarter and an adjustment to the equity investment in Mylan in the third quarter, expenses associated with acquisitions, including bridge facility fees, charges related to cost reduction initiatives and other expenses and the recognition of deferred taxes associated with the pending sale of the Abbott Medical Optics business (AMO), partially offset by the favorable resolution of various tax positions from prior years.

Excluding specified items, Abbott is raising the mid-point and narrowing its full-year 2016 guidance range for earnings per share from continuing operations to $2.19 to $2.21, exceeding its initial guidance for the year.

ABBOTT DECLARES 371ST QUARTERLY DIVIDEND

On Sept. 15, 2016, the board of directors of Abbott declared the company’s quarterly dividend of $0.26 per share. Abbott’s cash dividend is payable Nov. 15, 2016, to shareholders of record at the close of business on Oct. 14, 2016.

Abbott is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for 25 consecutive years.

On October 19, 2016 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that data from the Company’s Actimab-A program, Actinium’s most advanced alpha particle immunotherapy program intended for newly diagnosed AML patients over the age of 60, has been selected by the American Society of Hematology (ASH) (Free ASH Whitepaper) Program Committee for poster presentation at the 58th Annual Meeting in San Diego, California on December 5, 2016 (Press release, Actinium Pharmaceuticals, OCT 19, 2016, View Source [SID1234515918]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Title: Phase I Trial of Targeted Alpha-Particle Therapy with Actinium-225 (225Ac)-Lintuzumab and Low-Dose Cytarabine (LDAC) in Patients Age 60 or Older with Untreated Acute Myeloid Leukemia (AML)

Abstract: #4050

Session: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Location: San Diego Convention Center, Hall GH

Presentation: December 5, 6:00 PM – 8:00 PM

Abstracts are expected to be available at www.hematology.org on November 3, 2016 at 9:00 am Eastern time. In addition, the abstracts will be published online in the December 3, 2015 supplemental volume of Blood.

About Actimab-A

Actimab-A, Actinium’s most advanced alpha particle immunotherapy (APIT) program, is in a Phase 2 clinical trial for patients newly diagnosed with AML over the age of 60. Actimab-A is being developed as a first-line therapy and it has attracted support from some of the leading experts at the most prestigious cancer treatment hospitals due to the potential of its safety and efficacy profile. Actimab-A consists of the monoclonal antibody, HuM195, and the radioisotope, actinium-225. Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. HuM195 is the humanized version of M195 and is a monoclonal antibody that targets CD33, which is abundantly found on myeloid leukemia cells. Both the alpha particle technology and HuM195 were initially developed at Memorial Sloan Kettering Cancer Center. Actimab-A is a second-generation therapy from the Company’s HuM195-Alpha program, which has now been studied in almost 90 patients in four clinical trials.

On October 18, 2016 Athenex reported that its development partner for KX-02, Xiangxue Pharmaceuticals Company Limited, has publicized that the Guangdong Province Food and Drug Administration (FDA) declared completion of the Investigational New Drug (IND) application for KX-02 active pharmaceutical ingredient and KX-02 Tablet and referred the IND to the Center of Drug Evaluation (CDE) of China FDA for review (Press release, Athenex, OCT 18, 2016, View Source [SID1234525097]). The IND application to the Chinese FDA was submitted jointly by Xiangxue New Drug Development Company Limited, Xiangxue Pharmaceuticals Limited, and Hangzhou Converd Co., Ltd.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Guangdong Province FDA has determined, after their inspection of the factory and initial review of the IND submission, that it is complete and was referred to the Center of Drug Evaluation (CDE) of China FDA for review. This IND application has been assigned the application number CXHL1600187.

In 2012, Athenex and Xiangxue Pharmaceuticals announced the execution of a license agreement granting Xiangxue Pharmaceuticals exclusive rights to KX-02, for all oncology indications, in the greater China territory (China, Hong Kong, Taiwan) and Singapore.

KX-02, a novel lipophilic dual Src/pretubulin inhibitor, was discovered and developed by Athenex through their internal research and development efforts. It is a small molecule that has shown potent inhibitory activity against a broad panel of brain tumor cell lines, including cells (T98G) that are resistant to Temodar, the most widely used chemotherapy for the treatment of malignant glioma. In a well-established brain tumor animal model, KX-02 has been shown to consistently clear brain tumors after 4 weeks of therapy in 30-60% of treated animals. Pharmacokinetic studies showed that KX-02 is absorbed orally and has 76% penetration to brain tissue from plasma.

KX-02 is already in Phase 1 study in the US and has been assigned "Orphan Drug" status by the US FDA. Preclinical studies have shown that KX-02 showed excellent brain penetration and promising anti-tumor activities in mouse brain tumor models. A proportion of rodents cleared the tumor after 6 weeks of oral KX-02 treatment.

On October 18, 2016 Celgene Corporation (NASDAQ: CELG) and Sage Bionetworks reported a collaboration to develop an iPhone application utilizing the Apple ResearchKit framework to improve the understanding of the burden of disease for patients living with chronic anemia due to myelodysplastic syndromes (MDS) or beta-thalassemia (Press release, Celgene, OCT 18, 2016, View Source [SID1234515895]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Smartphone-based apps like Sage Bionetworks’ mPower for Parkinson’s disease are increasingly being utilized as a tool by clinical study researchers to collect and analyze increasing volumes of patient-reported data in order to better capture and understand disease burden better and to improve therapeutic developments. Smartphone clinical study apps also enable the return communication of important study information to the patient participants.

"We stand at a point where technology is unlocking the ability to capture patient reported outcomes," said Michael Pehl, President, Hematology & Oncology for Celgene. "Through our collaboration with Sage Bionetworks and the evolving capability of smartphones and wearables as robust data collection devices, we believe we will be able to provide important new insights for patients with MDS and beta-thalassemia. We are pleased to be working alongside Sage Bionetworks and the patient community on this important project."

Celgene and Sage Bionetworks have chosen to address chronic anemia caused by myelodysplastic syndromes and beta-thalassemia. These diseases impose a great burden on affected individuals that is difficult to understand and quantify, and typically have clinical endpoints outside traditional measures. The collaboration seeks to move to a paradigm where this and other information like physiological testing are collected on a multi-dimensional and regular basis.

Already a leader in MDS, Celgene is currently developing three assets in the clinic across myelodysplastic syndromes and beta-thalassemia (CC-486, luspatercept, and enasidenib (AG-221/CC-90007)).

In addition to helping collect difficult to quantify data, the new mobile study will collect neurological assessments of patients using cognitive testing software from BrainBaseline, a leading technology for the self-assessment of cognitive performance. The app will also be an important channel for two-way communication and support for patients living with their disease – allowing them to understand their physical functioning and other symptoms of anemia.

Dr. Lara Mangravite, President of Sage Bionetworks stated, "We are thrilled to partner with Celgene to explore the use of sensor-based technologies to quantify the daily burden of disease in patients with chronic anemia. This is a first of its kind exploration from which we hope to gain insights that can be used to understand the impact of chronic anemia."

Celgene and Sage Bionetworks are working closely with the MDS Foundation (www.mds-foundation.org) and Cooleys Anemia Foundation (www.thalassemai.org) in defining the right elements for capture in the application to ensure patient relevance and applicability.

On October 18, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported the commercial launch of two new translational research assays in the company’s Vantage 3D product line at the American Society of Human Genetics (ASHG) Annual Meeting in Vancouver Canada:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

nCounter Vantage 3D DNA (SNV) Solid Tumor Panel
nCounter Vantage 3D Protein Solid Tumor Signaling Pathways Panel

The two new panels can be combined with one another as well as with the nCounter Vantage RNA Panels to enable more comprehensive profiling of formalin-fixed, paraffin-embedded (FFPE) tumor tissue (Press release, NanoString Technologies, OCT 18, 2016, View Source [SID1234515900]). The nCounter Vantage 3D Solid Tumor portfolio provides a deeper understanding of genotype and phenotype in various solid tumor cancers by enabling multiplexed, digital analysis of combinations of DNA, RNA, fusion genes, proteins and phospho-proteins simultaneously in a single experiment. Researchers now have the ability to extract more biological information from the limited tissue available from each sample using just two FFPE slides. Designed for flexibility, the nCounter Vantage 3D Solid Tumor portfolio provides new ways for cancer researchers to apply 3D Biology technology.

The nCounter Vantage 3D Protein Solid Tumor Signaling Pathways Panel enables the identification of activation state through the measurement of total proteins and phospho-proteins from a single slice of FFPE tissue or from as little as 250 ng of protein from cell or tissue lysate. The protein solid tumor panel can be used in combination with nCounter Vantage 3D DNA Panels and nCounter Vantage 3D RNA Panels, or in combination with the 770 gene PanCancer Pathways Panel to provide comprehensive solid tumor profiling.

"Simultaneous measurement of DNA, RNA and proteins could change how we assess and treat cancer," said Gordon B. Mills M.D. Ph.D., Professor and Chair of Systems Biology at MD Anderson Cancer Center. "This new 3D Biology platform allows for an efficient approach to overcome this hurdle, and the identification of new biomarkers and signatures from a single platform could provide key clinical insights that can lead to a more personalized approach to medicine. Importantly, this platform could rapidly move to the clinic, directly benefitting patients."

"Identifying clinically actionable mutations that can be correlated with unique signatures and cell response is key to our biomarker discovery and signature development," said E. Aubrey Thompson, Ph.D., Professor of Cancer Biology, Mayo Clinic. "In the past we would have had to run multiple assays to answer our research question. Now we can run a single analysis, saving time and precious FFPE samples."

Many experiments involve measurements of DNA, RNA, and protein to determine the biological impact and correlation of genotypic and phenotypic changes. Traditionally, the analysis of all three biomolecules typically requires three separate platforms. This traditional approach has two important limitations: inefficient use of small samples and data compatibility challenges from using multiple platforms which creates uncertainty in determining whether discrepancies are due to biological factors or errors in measurement. The nCounter Vantage 3D Solid Tumor portfolio enables the simultaneous measurement of DNA, RNA and protein, addressing previous limitations.

The new products expand the portfolio of 3D Biology panels for analyzing solid tumors and FFPE tissue. The nCounter Vantage 3D DNA (SNV) Solid Tumor Panel is designed for highly multiplexed profiling of known cancer mutations, as well as insertions and deletions (INDELs) from as little as 5 nanograms of DNA.

NanoString will host a workshop at ASH (Free ASH Whitepaper)G where collaborators from MD Anderson Cancer Center and Fred Hutchinson Cancer Research Center will present data that demonstrate the robustness and sensitivity of the assay across a wide range of FFPE samples. The presentation, "3D Biology: Simultaneous Single-Molecule Quantification of DNA (SNVs), mRNA, Fusion Genes and Proteins Using Molecular Barcodes," will be held in Room 10 of the East Building, on Wednesday, October 19th from 1:00-2:30pm Pacific Time.

These new product launches demonstrate NanoString’s continued commitment to expanding the boundaries of biological research through 3D Biology. At the 2016 ASH (Free ASH Whitepaper)G Annual Meeting in Vancouver, British Columbia, NanoString will showcase nCounter Vantage 3D Solid Tumor capabilities at booth #512.