ACAD
18.26
+0.71
+4.05%
AEMD
4.84
-0.56
-10.37%
APRI
1.14
-0.03
-2.56%
ARNA
1.52
+0.05
+3.40%
ATEC
0.205
-0.004
-1.914%
CNAT
1.73
+0.08
+4.85%
CRXM
0.2
-0.03
-12.28%
CYTX
0.133
0.00
0.00%
DXCM
56.12
-0.13
-0.23%
GNMK
4.78
-0.26
-5.16%
HALO
7.54
+0.11
+1.48%
ILMN
142.72
+4.26
+3.08%
INNV
0.06
+0.01
+20.00%
INO
6.27
+0.08
+1.29%
ISCO
2.44
-0.17
-6.51%
ISIS
57.56
0.00
0.00%
LGND
85.97
+0.18
+0.21%
LPTN
0.156
+0.00
+0.0644%
MBVX
0.53
0.00
+0.23%
MEIP
1.04
-0.02
-1.89%
MNOV
4.19
-0.03
-0.71%
MRTX
20.11
+0.72
+3.71%
MSTX
0.256
+0.021
+8.7197%
NBIX
36.04
+0.67
+1.89%
NUVA
39.12
-2.7
-6.46%
ONCS
1.68
+0.17
+11.26%
ONVO
1.89
-0.04
-2.07%
OREX
1.64
-0.01
-0.61%
OTIC
14.33
+0.37
+2.65%
QDEL
14.99
-0.29
-1.90%
RCPT
231.96
0.00
0.00%
RGLS
5.84
-0.01
-0.17%
RMD
57.88
+0.76
+1.33%
SCIE
0.001
+0.00
+14.2857%
SPHS
1.58
+0.01
+0.64%
SRNE
5.52
+0.63
+12.88%
TROV
3.76
-0.15
-3.84%
VICL
0.305
-0.015
-4.6904%
VOLC
18
0.00
0.00%
ZGNX
9.79
+0.27
+2.84%
ACAD
18.26
+0.71
+4.05%
AEMD
4.84
-0.56
-10.37%
APRI
1.14
-0.03
-2.56%
ARNA
1.52
+0.05
+3.40%
ATEC
0.205
-0.004
-1.914%
CNAT
1.73
+0.08
+4.85%
CRXM
0.2
-0.03
-12.28%
CYTX
0.133
0.00
0.00%
DXCM
56.12
-0.13
-0.23%
GNMK
4.78
-0.26
-5.16%
HALO
7.54
+0.11
+1.48%
ILMN
142.72
+4.26
+3.08%
INNV
0.06
+0.01
+20.00%
INO
6.27
+0.08
+1.29%
ISCO
2.44
-0.17
-6.51%
ISIS
57.56
0.00
0.00%
LGND
85.97
+0.18
+0.21%
LPTN
0.156
+0.00
+0.0644%
MBVX
0.53
0.00
+0.23%
MEIP
1.04
-0.02
-1.89%
MNOV
4.19
-0.03
-0.71%
MRTX
20.11
+0.72
+3.71%
MSTX
0.256
+0.021
+8.7197%
NBIX
36.04
+0.67
+1.89%
NUVA
39.12
-2.7
-6.46%
ONCS
1.68
+0.17
+11.26%
ONVO
1.89
-0.04
-2.07%
OREX
1.64
-0.01
-0.61%
OTIC
14.33
+0.37
+2.65%
QDEL
14.99
-0.29
-1.90%
RCPT
231.96
0.00
0.00%
RGLS
5.84
-0.01
-0.17%
RMD
57.88
+0.76
+1.33%
SCIE
0.001
+0.00
+14.2857%
SPHS
1.58
+0.01
+0.64%
SRNE
5.52
+0.63
+12.88%
TROV
3.76
-0.15
-3.84%
VICL
0.305
-0.015
-4.6904%
VOLC
18
0.00
0.00%
ZGNX
9.79
+0.27
+2.84%
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Environmental Compliance Tech (Fallbrook)

February 11, 2016 – 3:23 pm

Under direction of the Chief Plant Operator, plans, organizes and has responsibility for the District contract laboratories, industrial waste program, Biosolids Reuse Program; ensures that the Wastewater and Water Recycling Division is in compliance […

Kindred Biosciences Submits Zimeta (KIND-012) New Animal Drug Application Technical Section for Effectiveness to FDA

February 11, 2016 – 2:02 pm

SAN FRANCISCO, Feb. 11, 2016 /PRNewswire/ — Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced the submission to FDA of the Effectiveness Technical Section of the New Animal Drug Application (NADA) for Zimeta™ (dipyrone injection, KIND-012).  Positive topline results from the pivotal field study (KB0120) of Zimeta for the control of pyrexia (fever) in horses were recently reported by the Company.

The Chemistry, Manufacturing, and Controls technical section for Zimeta was submitted in December 2015 and all remaining technical sections of the NADA are planned for submission by the end of the first quarter of 2016.

Richard Chin, CEO of KindredBio, stated, “We are pleased to bring Zimeta one step closer to approval. We believe that with its favorable safety profile in horses, Zimeta will offer an attractive first-in-class therapy for an important unmet medical need.”

Peter R. Morresey, BVSc, MACVSc, Dipl. ACVIM, Dipl. ACT of Rood and Riddle Equine Hospital in Lexington, KY stated, “Dipyrone will be very familiar to seasoned veterinarians.  While never approved in the United States, dipyrone enjoyed widespread usage for control of fever and pain before withdrawal from the market in 1995.  Since that time, it has continued to be widely used successfully in other countries.  If approved, it will be available again in the United States, in an FDA-approved formulation, a new generation of veterinarians and horses can benefit from dipyrone’s proven fever-controlling properties.”

About Kindred Biosciences, Inc. 

Kindred Biosciences is a development-stage biopharmaceutical company focused on saving and improving the lives of pets.  Its mission is to bring to pets the same kinds of safe and effective medicines that human family members enjoy.  The Company’s strategy is to identify compounds and targets that have already demonstrated safety and efficacy in humans and to develop therapeutics based on these validated compounds and targets for dogs, cats, and horses.  The Company has a deep pipeline of novel drugs and biologics in development across many therapeutic classes.

Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our expectations about the trials, regulatory approval, manufacturing, distribution and commercialization of our current and future product candidates, and statements regarding our anticipated revenues, expenses, margins, profits and use of cash. 

These forward-looking statements are based on our current expectations. These statements are not promises or guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results to be materially different from any future results expressed or implied by the forward-looking statements.  These risks include, but are not limited to, the following:  our limited operating history and expectations of losses for the foreseeable future; the absence of revenue from our product candidates for the foreseeable future; our potential inability to obtain any necessary additional financing; our substantial dependence on the success of our lead product candidates, which may not be successfully commercialized even if they are approved for marketing; the effect of competition; our potential inability to obtain regulatory approval for our existing or future product candidates; our dependence on third parties to conduct some of our development activities; our dependence upon third-party manufacturers for supplies of our product candidates; uncertainties regarding the outcomes of trials regarding our product candidates; our potential failure to attract and retain senior management and key scientific personnel; uncertainty about our ability to develop a satisfactory sales organization; our significant costs of operating as a public company; our potential inability to obtain patent protection and other intellectual property protection for our product candidates; potential claims by third parties alleging our infringement of their patents and other intellectual property rights; our potential failure to comply with regulatory requirements, which are subject to change on an ongoing basis; the potential volatility of our stock price; and the significant control over our business by our principal stockholders and management.  

For a further description of these risks and other risks that we face, please see the risk factors described in our filings with the U.S. Securities and Exchange Commission (the SEC), including the risk factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K and any subsequent updates that may be contained in our Quarterly Reports on Form 10-Q filed with the SEC.  As a result of the risks described above and in our filings with the SEC, actual results may differ materially from those indicated by the forward-looking statements made in this press release.   Forward-looking statements contained in this press release speak only as of the date of this press release and we undertake no obligation to update or revise these statements, except as may be required by law. 

Contact

Russell Radefeld
KindredBio
Russell.radefeld@kindredbio.com 
(650) 701-7904

 

SOURCE Kindred Biosciences, Inc.

Neurocrine Biosciences Reports Year-End 2015 Results and Provides Investor Update for 2016

February 11, 2016 – 2:01 pm

Valbenazine New Drug Application to be filed for Tardive Dyskinesia this YearSecond Elagolix Phase III Study in Endometriosis is SuccessfulTwo Phase III Studies of Elagolix in Uterine Fibroids UnderwayTwo Phase II Studies of Valbenazine in Tourette Syndrome Expected to Readout Near Year-EndTwo Clinical Trial Readouts Expected in 2016 from Essential Tremor Drug Candidate NBI-640756

SAN DIEGO, Feb. 11, 2016 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the quarter and year ended December 31, 2015.

For the fourth quarter of 2015, the Company reported a net loss of $29.3 million, or $0.34 loss per share, compared to a net loss of $19.4 million, or $0.26 loss per share for the same period in 2014. For the year ended December 31, 2015, the Company reported a net loss of $88.9 million, or $1.05 loss per share, as compared to a net loss of $60.5 million, or $0.81 loss per share for 2014. The increase in net loss for the fourth quarter and full year results primarily from increased research and development expenses in connection with the Company’s advancing clinical stage pipeline, valbenazine pre-commercialization activities for tardive dyskinesia and higher share-based compensation expense as detailed below.

The Company’s balance sheet at December 31, 2015 reflected total assets of $474.8 million, including cash, investments and receivables of $464.3 million compared with balances at December 31, 2014 of $243.0 million and $232.6 million, respectively.

“We begin 2016 with positive top-line data from our partner AbbVie in the second Phase III study of elagolix in endometriosis coupled with the start of two Phase III studies of elagolix in uterine fibroids,” said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences. “Recently we reported a highly positive Phase III study of valbenazine in tardive dyskinesia and now look forward to filing our valbenazine NDA for tardive dyskinesia with the FDA this year. We have also initiated two Phase II studies of valbenazine in Tourette syndrome with data on these expected around the end of the year. Additionally, we have NBI-640756, our drug candidate for essential tremor, in the clinic and we look to add yet another new compound to our clinical pipeline later this year.”

Research and development expenses were $21.8 million during the fourth quarter of 2015, compared to $15.5 million for the same period in 2014. For the year ended December 31, 2015, research and development expenses were $81.5 million, compared to $46.4 million for all of 2014. The increase in research and development expense was due to higher external clinical development expenses and associated internal costs related to NBI-98854, which initiated Phase III development in the second half of 2014, as well as preparations for a potential New Drug Application filing in 2016. Additionally, year-to-date share-based compensation expense increased by $7.9 million from 2014 levels primarily due to performance-based restricted stock units.

General and administrative expenses increased from $5.0 million for the fourth quarter of 2014 to $8.9 million for the fourth quarter of 2015. For the year ended December 31, 2015 general and administrative expenses were $32.5 million, compared to $18.0 million for the prior year. The increase in general and administrative expense is primarily due to higher personnel related costs, including a $10.1 million increase in year-to-date share-based compensation expense primarily due to performance-based restricted stock units. Additionally, professional costs related to market research and pre-commercialization activities contributed to the overall increase in general and administrative expenses.

2016 Financial Guidance

The Company expects to have a cash burn of approximately $135 million to $145 million in 2016. The increase in cash burn from 2015 is primarily due to preparing for commercialization of valbenazine in tardive dyskinesia coupled with expansion and progression of the clinical pipeline.  Revenues for 2016 are expected to be approximately $15 million. Expenses for 2016 should approximate $185 million to $195 million. The anticipated expenses include an estimated $30 million for share-based compensation expense.

Pipeline Highlights

Valbenazine Update

During the fourth quarter of 2015, the Company announced positive top-line results from the Kinect 3 study, a Phase III trial that included moderate to severe tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder. The Kinect 3 study randomized 234 subjects to either placebo, once-daily 40mg of NBI-98854 (valbenazine), or once-daily 80mg of valbenazine for six weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48. The primary efficacy endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 in the 80mg once-daily dosing group compared to placebo as assessed by central blinded video raters. The AIMS ratings at Week 6 for the 80mg once-daily valbenazine intention-to-treat (ITT) population was reduced 3.1 points (Least-Squares Mean) more than placebo (p<0.0001). During the six-week placebo-controlled treatment period valbenazine was generally well tolerated. The frequency of adverse events was similar among all treatment groups and treatment emergent adverse effects were consistent with those of prior studies.

In addition to the ongoing safety assessment of Kinect 3, the Company is also conducting a separate one-year open-label safety study of valbenazine, Kinect 4, to support the anticipated 2016 filing of a New Drug Application of valbenazine in tardive dyskinesia. As announced previously, Neurocrine has received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia.

The Company is also exploring valbenazine in Tourette syndrome. The initial Tourette’s clinical trial, the T-Force study, was an open-label, multi-dose, two-week evaluation of 28 subjects with Tourette syndrome. Children and adolescents enrolled in the trial are receiving a once-daily dose of valbenazine during a two-week treatment period to assess both the safety and tolerability of valbenazine. Valbenazine was generally safe and well tolerated. The Yale Global Tic Severity Scale was also assessed and after two weeks of treatment showed a mean reduction of 31% from baseline scores, with over half of the subjects considered clinical responders.

The Company recently announced the initiation of two Phase II Tourette syndrome studies evaluating valbenazine in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively.

The T-Forward study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 adults. Subjects will receive once-daily dosing of valbenazine during an eight-week treatment period to assess the safety, tolerability and efficacy of valbenazine in adult Tourette patients. The primary endpoint of this study is a change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 8.

The T-Force GREEN study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 children and adolescents. Subjects will receive once-daily dosing of valbenazine during a six-week treatment period to assess the safety, tolerability and efficacy of valbenazine in pediatric Tourette patients. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of week six.

Data from both of these Tourette studies is expected around year-end 2016.

Elagolix Update

AbbVie recently announced positive top-line results from the second of two Phase III clinical trials, the Solstice Study, a multinational study designed to evaluate the efficacy and safety of elagolix in 815 premenopausal women with endometriosis. The top-line results from this trial were consistent with those of the initial Phase III clinical trial, the Violet Petal Study, where after six months of treatment, both doses of elagolix (150 mg once-daily and 200 mg twice-daily) met the study’s co-primary endpoints of reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea) associated with endometriosis at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale. The observed safety profile of elagolix in the Solstice study was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache, and nausea. While most AEs were similar across treatment groups some, such as hot flush and bone mineral density loss, were dose-dependent. AbbVie is targeting a 2017 New Drug Application filing with the FDA for elagolix in endometriosis.

In early 2016, AbbVie announced the initiation of the Phase III uterine fibroids program consisting of two replicate randomized, parallel, double-blind, placebo-controlled clinical trials evaluating elagolix alone or in combination with add-back therapy in women with heavy uterine bleeding associated with uterine fibroids. The studies are expected to enroll approximately 400 subjects each for an initial six-month placebo-controlled dosing period. At the end of the six-months of placebo-controlled evaluation, subjects are eligible to enter an additional six-month safety extension study. The primary efficacy endpoint of the study is an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints will be evaluated including assessing the change in fibroid volume and hemoglobin. Bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing, and six months post-dosing.

In September 2015, AbbVie announced positive top-line results from a Phase IIb clinical trial in women with heavy menstrual bleeding associated with uterine fibroids. The trial evaluated the safety and efficacy of elagolix alone or in combination with add-back therapy compared to placebo. Preliminary results showed that all of the elagolix treatment arms, with and without add-back therapy, reduced heavy menstrual bleeding as compared to placebo (p<0.001). Among the most common adverse AEs were hot flush, headache, nausea, and vomiting. Some AEs such as hot flush were more frequent in the elagolix only treatment arms as compared to the placebo and elagolix with add-back therapy treatment arms. Bone mineral density loss associated with elagolix alone was attenuated when elagolix was co-administered with add-back therapy.

Essential Tremor Program (NBI-640756) Update

NBI-640756 for patients with essential tremor was discovered in the Neurocrine laboratories. The Company has initiated a single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers.  The study is being conducted in multiple sequential cohorts of eight subjects per cohort. Top-line data from this Phase I study is expected in the first-half of 2016.

Conference Call and Webcast Today at 4:30 PM Eastern Time
Neurocrine will hold a live conference call and webcast today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). Participants can access the live conference call by dialing 866-952-7534 (US) or 785-424-1835 (International) using the conference ID: NBIX. The call can also be accessed via the webcast through the Company’s website at http://www.neurocrine.com.

If you are unable to attend the webcast and would like further information on this announcement please contact the Investor Relations Department at Neurocrine Biosciences at (858) 617-7600. A replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 800-677-6124 (US) or 402-220-0664 (International) using the conference ID: NBIX. The call will be archived for one month.

Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders. The Company’s two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie Inc., and valbenazine, a vesicular monoamine transporter 2 inhibitor for the treatment of movement disorders. Neurocrine intends to maintain certain commercial rights to its VMAT2 inhibitor for evolution into a fully-integrated pharmaceutical company.

Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com.

In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine’s business and finances in general, as well as risks and uncertainties associated with the Company’s R & D pipeline and the Company overall. Specifically, the risks and uncertainties the Company faces include risks that regulatory submissions may not occur or be submitted in a timely manner; risks that the Company’s product candidates may not obtain regulatory approval or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding the Company’s product candidates; risks associated with the Company’s dependence on AbbVie for the development and commercialization of elagolix; risks that clinical development activities may not be completed on time or at all; risks that clinical development activities may be delayed for regulatory or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be  predictive of real-world results or of results in subsequent clinical trials;  risks that the Company’s product candidates may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse;  risks associated with the Company’s dependence on third parties for development, manufacturing and marketing activities; risks that the Company’s research programs will not identify pre-clinical candidates for further development;  risks that the Company will be unable to raise additional funding required to complete development of all of its product candidates; risk and uncertainties relating to competitive products and technological changes that may limit demand for the Company’s products; and other risks described in the Company’s annual report on Form 10-K for the year ended December 31, 2014 and quarterly reports on Form 10-Q for the quarters ended March 31, 2015, June 30, 2015 and September 30, 2015. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.

NEUROCRINE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

Three Months Ended
December 31,

Year Ended
December 31,

2015

2014

2015

2014

Revenues:

Milestones and license fees

$               –

$               –

$       19,769

$                 –

Total revenues

19,769

Operating expenses:

Research and development

21,809

15,498

81,491

46,425

General and administrative

8,939

4,970

32,480

17,986

Total operating expenses

30,748

20,468

113,971

64,411

Loss from operations

(30,748)

(20,468)

(94,202)

(64,411)

Other income:

(Loss) gain on sale/disposal of assets

9

(4)

Deferred gain on real estate

838

812

3,325

3,226

Investment income, net

584

197

1,928

629

Other income, net

11

15

11

18

Total other income

1,433

1,024

5,273

3,869

Net loss

$   (29,315)

$   (19,444)

$    (88,929)

$    (60,452)

Net loss per common share:

Basic and Diluted

$       (0.34)

$       (0.26)

$        (1.05)

$        (0.81)

Shares used in the calculation of net (loss) income per common share:

Basic and Diluted

86,184

76,139

84,496

74,577

 

NEUROCRINE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

December 31,
2015

December 31,
2014

Cash, cash equivalents and short-term marketable securities

$       379,191

$       193,809

Other current assets

4,883

4,394

Total current assets

384,074

198,203

Property and equipment, net

3,432

2,507

Long-term investments

82,488

37,492

Restricted cash

4,791

4,831

Total assets

$       474,785

$       243,033

Current liabilities

$         25,715

$         15,664

Long-term liabilities

24,616

18,670

Stockholders’ equity

424,454

208,699

Total liabilities and stockholders’ equity

$       474,785

$       243,033

 

SOURCE Neurocrine Biosciences, Inc.

Research Associate – Assay Development (Sorrento Mesa)

February 11, 2016 – 1:31 pm

Position Summary
This position performs the experiments to develop new assays on Genalyte’s Maverick? instrument, puts the results in the proper format for analysis and keeps a detailed lab notebook in a clear format. This position expects high qual […

Glassware Technicians (North County)

February 11, 2016 – 11:31 am

Looking for individuals who have experience cleaning beakers and other glassware in a laboratory environment. Also experience with autoclave glass washing machines a plus.
This position is part time 12 plus hours a week. Monday, Wednesday & Friday
[…]

Director, Clinical Genome Informatics – Illumina, Inc. – San Diego, CA

February 11, 2016 – 11:28 am

Our customers include a broad range of academic, government, pharmaceutical, biotechnology, and other leading institutions around the globe….
From Illumina, Inc. – 11 Feb 2016 18:28:18 GMT
– View all San Diego jobs

Courier (Independent Contractor)

February 11, 2016 – 10:27 am

A Biotech Company is seeking to contract services of an Independent Contract Courier to pick up samples from the San Diego & La Jolla, CA areas & deliver to our La Jolla Laboratory. Samples will be picked up on an as needed basis; Monday – Friday, be […]

Changing the Future

February 11, 2016 – 7:00 am

UC San Diego Division of Social Sciences alumna Helen Griffith had little interest in a career in education when she came to campus as a transfer student. There was no way, she said, she would work around the clock…

Innovative Cell-Isolation System Points to New Model of Clinical Biopsy for Precise Characterization, Diagnosis and Treatment of Tumors

February 11, 2016 – 3:00 am

Scientific Study Shows DEPArray(TM) Digital Technology Enables Unambiguous Genetic Analysis of Formalin-Fixed Paraffin-Embedded (FFPE) Admixtures of Tumor Cells

SAN DIEGO, Feb. 11, 2016 /PRNewswire/ — Scientists from Silicon Biosystems Menarini today reported a groundbreaking cell-isolation method that opens the door to genetic analysis of previously preserved tumor sam­ples that until now have been impossible to isolate with 100 percent purity. Utilizing the com­pany’s DEPArray™ technology to isolate specific tumor types in various stages of development, the researchers were able to characterize genetic variants of these cells that are clinically relevant, and may change the way tumor biopsies are characterized and diagnosed, laying the foundation for more precise cancer treatments. The study was reported today in the journal, Scientific Reports, a Nature publication.* 

The DEPArray cell-isolation system optimizes high-throughput genetic analysis — so-called “next genera­tion sequencing” (NGS) methods of molecular characterization — by adding digital precision to the pro­cess of sample preparation. “NGS has the potential to revolutionize clinical oncology by providing direct, actionable molecular information about tumor cells. Such information can be critical to developing per­sonalized medical treatments against specific tumor types, as well as to stratify patients for appropriate clinical trials,” explained Nicolo Manaresi, Ph.D., Chief Scientific Officer at Silicon Biosystems Menarini and the lead investigator in the study.

Overcoming FFPE and Tumor Heterogeneity
The power of NGS, however, is largely negated by FFPE — the de facto laboratory practice of preserving biopsy samples in formalin and embedding them with paraffin wax so they can be thin-sectioned for microscopic viewing. NGS is further compromised by “tumor heterogeneity” — the fact that tumor cells undergo dynamic cellular changes over time, constantly generating variant cell subpopulations that spread throughout the body. Moreover, heterogeneity inside the tumor cell population itself limits the possibility to identify drivers of tumor development, as low represented clones may actually be the ones responsible for more malignant traits.

Targeted cancer treatment requires monitoring these cell changes at the molecular level, especially those cells that have acquired drug resistance. Thus primary tumors become less relevant sources of molecular information, while monitoring of the evolution of specific cells in the course of the disease is critical for tailoring more precise patient treatment.

“Pre-analytical resolution of tumor heterogeneity is a major step forward for precision medicine,” added Dr. Manaresi. “By enabling the addition of precise sample preparation to the NGS workflow, the DEPArray system brings precision medicine concepts such as personalized therapy, molecular monitor­ing of response to therapy, and liquid biopsy into the realm of practical possibility.”

Unlocking the Power of Next Generation Sequencing for Tumor Analysis
Current available technology to solve sample heterogeneity, such as laser-capture microdissection and fluorescence-activated cell sorting (FACS) lack the accuracy and purity required for clinical use, and their power is often limited by the size and quality of the starting sample materials. The studied showed that the DEPArray cell-sorting and isolation technology, followed by NGS analysis, can reveal comprehensive genomic information from any FFPE sample, regardless of sample cellularity and size of the specimen. Moreover, the methodology informs a new model for conducting clinical biopsies of tumors, as well as for performing translational cancer research and the way new cancer drugs are developed and biomarkers discovered.

“The method we have developed, based on a pre-analytic digital cell separation from FFPE samples, achieves 100% purity of the sample, substantially reverting the DNA composition to a germline-like situa­tion where NGS techniques can display all their power and reliability,” said Dr. Manaresi. “Data analysis and interpretation of results are also drastically simplified and different classes of genetic alterations can be solved with unprecedented precision.”

Selection and Isolation with Single-Cell Precision
Based on the principle of dielectrophoresis, which exploits the ability of a non-uniform electric field to move cells in a spatial gradient, the DEPArray platform provides precise image-based cell selection for identification and sorting of individual cells, or pools of cells, at 100% purity for further genetic analysis or culturing. The system enables investigators to recover desired live cells from a mixed tissue sample, such as FFPE samples, or from frozen tumor specimens, and cell cultures.

About Silicon Biosystems Menarini
Silicon Biosystems Menarini, based in San Diego, Calif. and Bologna, Italy, is a wholly owned subsidiary of The Menarini Group, a multinational pharmaceutical, biotechnology and diagnostics company head­quartered in Florence, Italy, with a heritage of over 130 years and over 16,000 employees in more than 100 countries. The company manufactures and sells the DEPArray system, which enables researchers to automatically identify, quantify, and recover individual rare cells with single-cell precision. For more information visit http://www.siliconbiosystems.com.

* Bolognesi, C. et al. Digital Sorting of Pure Cell Populations Enables Unambiguous Genetic Analysis of Heterogeneous Formalin-Fixed Paraffin-Embedded Tumors by Next Generation Sequencing. Sci. Rep. 6, 20944; doi: 10.1038/srep20944 (2016).

 

SOURCE Silicon Biosystems Menarini

Postdoctoral Fellow, Assembly of Postsynaptic Signaling Complexes – Janssen Research & Development, LLC. – San Diego, CA

February 11, 2016 – 12:34 am

Requisition ID: 2168160128 Janssen Research & Development, L.L.C., a Johnson and Johnson Company is hiring a Postdoctoral Scientist, Postdoctoral Fellow to
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