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OPKO Health Expands Portfolio of Tests for Inherited Forms of Cancer

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MIAMI–(BUSINESS WIRE)– OPKO Health, Inc. (NYSE:OPK) announced today that its GeneDx business unit has expanded its inherited cancer panel offerings and genetic tests to include four additional genes.

The four genes are POLD1, POLE, SCG5/GREM1, and SMARCA4. Three of the genes, POLD1, POLE and SCG5/GREM1, are associated with colon polyposis, colon cancer and endometrial cancer; while SMARCA4 is associated with an increased risk of a rare form of ovarian cancer. With the addition of these genes to the inherited cancer testing portfolio, it is possible to more effectively identify patients at risk. Once abnormalities are identified, patients can work with their healthcare providers to understand their specific cancer risk and what they can do to manage that risk.

“The addition of these four genes to the genetic tests now available from GeneDx can help in the diagnosis of rare syndromes associated with increased risk of colorectal, endometrial, ovarian and other cancers,” said Marc. D. Grodman, M.D., CEO of BioReference Laboratories Inc., a subsidiary of OPKO.

The new gene panels and tests are available now for physicians to order from the GeneDx website. For more information, please visit www.genedx.com or email us at [email protected].

About OPKO Health, Inc.

OPKO is a multi-national biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large and rapidly growing medical markets by leveraging our discovery, development and commercialization expertise and our novel and proprietary technologies. For more information, visit http://www.opko.com.

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including statements regarding expectations about our inherited cancer testing portfolio and the additional genes we have added to our tests, the ability to more effectively identify patients at risk for cancer, accelerate the diagnosis of rare syndromes associated with increased risk for different forms of cancer, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Company
OPKO Health, Inc.
Tara Mackay, 305-575-4100
Investor Relations
or
Media
Rooney & Associates
Terry Rooney, 212-223-0689
[email protected]
or
Marion Janic, 212-223-4017
[email protected]
or
Investors
LHA
Anne Marie Fields, 212-838-3777
[email protected]
or
Bruce Voss, 310-691-7100
[email protected]

Source: OPKO Health, Inc.

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InVivo Therapeutics Reports Significant Improvement of First Patient Implanted with Neuro-Spinal Scaffold™

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CAMBRIDGE, Mass. (Oct 23, 2015) – InVivo Therapeutics Holdings Corp. (NVIV) today announced a 12- month post-implant update for the first study patient in the company’s ongoing pilot trial of its investigational Neuro-Spinal ScaffoldTM in patients with complete acute spinal cord injury.

In the time between the 6-month and 12-month post-injury assessments, the patient continued to demonstrate improvement in the American Spinal Injury Association (ASIA) lower extremity motor score with an additional 8 points gained on this 50 point score. The patient demonstrated additional bilateral improvements in the motor function of hip flexors and knee extensors and for the first time bilateral contractions of the ankle dorsiflexors and ankle plantar flexors.

A large natural history database shows that patients with similar level injuries (T10-T12) have an average increase of lower extremity motor scores between 6 and 12 months of fewer than 2 points.

“I am delighted that our first patient continued to experience significant motor improvement after the 6-month visit. It is particularly exciting that the patient is regaining motor function in the ankle region as this indicates recovery is occurring not only in muscles that demonstrated some early recovery, but also in new muscles further down the legs. We are all hoping for continued improvement for the patient in the future. It was a brave decision to volunteer to be the first person ever to receive our investigational product, and it has been rewarding to observe the patient’s steady improvement over the last year,” said Mark Perrin, InVivo’s CEO and Chairman.

About the Neuro-Spinal ScaffoldTM

Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics 

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

 

Posted in Press Releases