FDA Approves Hologic's Aptima HPV 16 18/45 Genotype Assay; Celator to Begin Trading on NASDAQ on November 11, 2013 Print E-mail
By Staff and Wire Reports   
Thursday, 07 November 2013 20:28
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 7, 2013.

Hologic, Inc. (NASDAQ: HOLX)
, a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, announced the U.S. Food and Drug Administration (FDA) has approved the Aptima HPV 16 18/45 genotype assay for use on the Company's fully automated Panther system. The Aptima HPV 16 18/45 genotype assay is performed using Hologic's ThinPrep liquid cytology specimen and is intended to be tested from the same sample that has already received Aptima HPV assay positive results.

Hologic's Aptima HPV 16 18/45 genotype assay is the first test FDA‐approved for genotyping human papillomavirus (HPV) types 16, 18 and/or 45. Recent data suggests that although cervical cancer incidence has decreased since the 1970s, the prevalence of adenocarcinoma cases has risen approximately 32 percent in the same time frame.^1 Detection of these HPV types as part of reflex testing may help clinicians identify up to 94 percent of all cervical adenocarcinomas.^2

Although HPV genotype 45 is fairly uncommon, identified in only 0.4 percent of women with normal cytology,  data indicates that it is the third most common HPV genotype in invasive cancer. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates. Studies have shown that HPV types 16, 18 and 45 are more likely to be integrated into the human genome than are the other HPV types, and tumors with these genotypes may present earlier.^2

"The addition of the Aptima HPV 16 18/45 genotype assay to the Panther menu further extends the capability of low- to high-volume laboratories to run multiple tests from a single specimen, on a cost-effective, highly flexible and fully automated molecular testing platform," said Rohan Hastie, Ph.D., Hologic's Group Vice President – Diagnostics.

The Aptima HPV 16 18/45 genotype assay is intended to test specimens from women with Aptima HPV assay positive results.  The FDA has approved the test for two uses:

 1. In patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.  2. In patients 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18 and/or 45. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

The Aptima HPV 16 18/45 genotype assay was CE marked in December 2011 and received FDA approval on the Hologic high-throughput Tigris system in October 2012.


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Celator Pharmaceuticals, Inc. (OTCBB:CLPM)
, a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that its common stock has been approved for listing on the NASDAQ Capital Market and is expected to begin trading on Monday, November 11, 2013 under the symbol CPXX. The company's common stock will continue to trade on the Over the Counter Bulletin Board, under the symbol CLPM, until the market close on Friday, November 8, 2013.

"This is an important milestone to Celator's success as a public company," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "We believe that listing with NASDAQ will raise awareness of the company with the investment community and help increase our liquidity."



Also Thursday:




Abiomed, Inc. (Nasdaq:ABMD)
, a leading provider of breakthrough heart support technologies, today announced that Robert L. Bowen, Vice President and Chief Financial Officer, and Susan V. Lisa, Senior Director, Investor Relations and Corporate Development, will present at the 2013 Credit Suisse Healthcare Conference on Thursday, November 14, 2013 at 8:30 a.m. MST.

Accuray Incorporated (Nasdaq: ARAY)
, announced today the publication of two papers stemming from a large multi-center study of CyberKnife® stereotactic body radiotherapy (SBRT) led by investigators at the University of California, Los Angeles (UCLA).

Accuray Incorporated (Nasdaq: ARAY)
announced today financial results for the first fiscal quarter ended September 30, 2013.

Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, today announced its financial results for the third quarter of fiscal year 2013, ended September 30, 2013.

Amarin Corporation plc (Nasdaq:AMRN)
, a late stage biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for Q3, the quarter ended September 30, 2013, and provided an update on company operations.

Arena Pharmaceuticals, Inc. (NASDAQ: ARNA)
and Eisai Inc. announcedtoday the expansion of the BELVIQ® (lorcaserin HCl) marketing and supply agreement between Arena Pharmaceuticals, Inc.'s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. along with its parent company Eisai Co., Ltd.

Biodel Inc. (Nasdaq:BIOD)
today announced the initiation of a Phase 1 clinical trial under its existing U.S. Investigational New Drug Application, as part of the development program for concentrated insulin candidate BIOD-531.

Biota Pharmaceuticals, Inc. (Nasdaq:BOTA)
today announced its financial results for the three month period ended September 30, 2013.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, a DNA-based diagnostics company focused on developing genomic-based oncology tests and services, announced today that it will present data from a six-month research collaboration with the Memorial Sloan-Kettering Cancer Center, at the Association for Molecular Pathology (AMP) 2013 Annual Conference.

Cell Therapeutics, Inc. (NASDAQ and MTA: CTIC)
today announced the upcoming presentations of data highlighting pacritinib, a novel, oral JAK2/FLT3 inhibitor, and tosedostat, an aminopeptidase inhibitor, at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 7-10, 2013 in New Orleans, LA.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
today reported data from its ongoing Phase 1 dose-escalation study of the fully human monoclonal antibody CDX-1127. The results suggest an excellent safety profile and demonstrate clear biologic activity and promising signs of clinical activity in an advanced, refractory patient population. No maximum tolerated dose has been reached to date.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, a leader in point-of-care diagnostic tests for infectious diseases, today reported financial results for the three and nine months ended September 30, 2013.

ChemoCentryx, Inc., (Nasdaq:CCXI)
, a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, announced today its financial results for the third quarter ended September 30, 2013.

Coronado Biosciences, Inc. (Nasdaq:CNDO)
, a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that it has been informed by Dr. Falk Pharma GmbH (Falk), its development partner, that an Independent Data Monitoring Committee (IDMC) has conducted a second interim analysis of clinical data from approximately 240 patients who have completed 12 weeks of treatment in Falk's Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, today announced that researchers will present new data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the Company's lead product candidate, in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine and/or decitabine, at the 55th Annual Meeting of the American Society of Hematology (ASH).

Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, an emerging leader in development, assembly, marketing and sales of medical devices and homecare medical products, announced today that it has completed research and development for its new DHR-998 sleep diagnostics device.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR)
, a premier provider of long-term care services primarily in the Southeast and Southwest, today announced its results for the third quarter ended September 30, 2013.

Ebix, Inc. (Nasdaq:EBIX)
, a leading international supplier of On-Demand software and E-commerce services to the insurance industry, announced that the Company's A.D.A.M. SmartEngage™ product recently won Best Unbranded Consumer Website/Microsite at the 4th Annual Digital Marketing Canada Summit October 28-29, 2013 at the West Prince Toronto.

Endocyte, Inc. (Nasdaq:ECYT)
, a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that Colin Goddard, Ph.D. has joined Endocyte's board of directors.

The Ensign Group, Inc. (Nasdaq:ENSG)
, the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, assisted and independent living, home health, hospice care and urgent care companies, today reported operating results for the third quarter of 2013.

eRAD, a subsidiary of RadNet, Inc. (Nasdaq:RDNT), a leading provider of standards-based, web-centric radiology image and data management solutions, announced today that Medical Radiologists, Inc., has deployed eRAD technology to support its growing teleradiology business.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced financial results for the three and nine months ended September 30, 2013.

Jamba Juice Company (Nasdaq:JMBA)
, a leading healthy, active lifestyle brand, in partnership with the University of San Francisco and the GENYOUth Foundation, an organization dedicated to nurturing child health and wellness through healthy nutrition and increased opportunities for physical activity, today hosted a gathering of local leaders across business, education, health, government and sports in a dialogue addressing Bay Area school wellness, which reinforced the three organizations' commitment to improving childhood nutrition and fitness.

LifeVantage Corporation (Nasdaq:LFVN)
, a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, today reported financial results for the fiscal 2014 first quarter ended September 30, 2013.

Marrone Bio Innovations, Inc. (Nasdaq:MBII),
a provider of bio-based pest management and plant health products for the agricultural and water treatment markets, announced today that its Chief Financial Officer, Don Glidewell, has determined to retire from the Company.

MediciNova, Inc., (Nasdaq:MNOV)
a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the Jasdaq Market of the Tokyo Stock Exchange (Code Number:4875), today announced financial results for the third quarter ended September 30, 2013.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
, a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer, today provided its third quarter 2013 operating update and financial results.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy market, today announced its third quarter results and provided highlights of its recent activities.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has acquired the exclusive worldwide rights to use the cellulose-based live-cell encapsulation technology for the development of treatments for diabetes from SG Austria Pte. Ltd.

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI)
today announced third quarter 2013 financial results and will address frequently asked questions from investors during the quarterly conference call.  

Onconova Therapeutics, Inc. (Nasdaq:ONTX)
, a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced two presentations relating to clinical trials of its most advance product candidate, rigosertib, at the 55th American Society of Hematology (ASH) Annual Meeting in New Orleans, Louisiana, December 7-10, 2013.

OraSure Technologies, Inc. (Nasdaq:OSUR)
today announced that Ronald H. Spair, COO & CFO, will speak to the investment community at Canaccord|Genuity's Medical Technology & Diagnostics Forum in New York City. The conference will be simultaneously webcast over the Internet.

Prosensa Holding N.V. (NASDAQ: RNA)
, the Dutch biopharmaceutical company focusing on RNA-modulating therapeutics for rare diseases with high unmet need, today announced the successful enrollment of the 100th  patient into the Natural History Study of Duchenne muscular dystrophy (DMD).

QLT Inc. (Nasdaq:QLTI) (TSX:QLT)
is a biotechnology company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide.

Raptor Pharmaceutical Corp. (Nasdaq:RPTP)
today provided financial results for its third quarter and nine months ended September 30, 2013.

Repligen Corporation (Nasdaq:RGEN) today reported financial results for the third quarter ended September 30, 2013.

Repros Therapeutics Inc.® (Nasdaq:RPRX)
today announced financial results for the third quarter ended September 30, 2013.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced its consolidated financial results and business progress for the third quarter ended September 30, 2013.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA)
announced today the origination of a $14.7 million interim mortgage loan and a $17.1 million construction mortgage loan commitment.

SANUWAVE Health, Inc. (OTCBB:SNWV)
today announced that the Company will release financial results for the third quarter ended September 30, 2013 prior to the opening of the market on Tuesday, November 12, 2013.

Spine Pain Management, Inc. (OTCQB:SPIN)
, a technology-driven, financial service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced financial results for the third quarter 2013.

Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM)
, a leading developer of RNA interference (RNAi) therapeutics, announced that it will hold a conference call and webcast on Wednesday, November 13, 2013 at 1:30 pm Pacific Time (4:30 pm Eastern Time) to provide a corporate update and report financial results for the third quarter ended September 30, 2013.

TESARO, Inc. (Nasdaq:TSRO)
, an oncology-focused biopharmaceutical company, today reported financial results for the third quarter of 2013.

XOMA Corporation (Nasdaq:XOMA
), a leader in the discovery and development of therapeutic antibodies, today reported its operational highlights and financial results for the quarter ended September 30, 2013.



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