A Medical Device Daily

Sequenom (San Diego) and Lenetix Medical Screening Laboratory (Mineola, New York), a provider of genetic screening and diagnostic testing for clinicians worldwide, reported that they have entered into a collaboration-and-license agreement to develop and commercialize a non-invasive prenatal Rhesus D (RhD) incompatibility test based on Sequenom patent rights and RT polymerase chain reaction methodology.

Financial terms of the agreement were not disclosed.

The RhD test, Sequenom’s first non-invasive prenatal test, is expected to be marketed as a “home brew” test in the U.S. in the first half of this year.

“The non-invasive characterization of fetal Rh genotype and other fetal genetic information has the potential to transform the practice of prenatal risk assessment,” said Leonard Kellner, president of Lenetix. “This new approach to non-invasive evaluation of a baby in utero is a very exciting scientific and commercial development, and may significantly reduce the need for invasive fetal diagnostic tests such as amniocentesis or chorionic villus sampling.”

RhD blood group incompatibility between a pregnant woman and her fetus is a significant health problem due to the possibility of maternal alloimmunization and consequent hemolytic disease of newborns. Although the pregnancy in which alloimmunization first occurs results in an unaffected child, future children are at substantial risk of anemia and, in the worst cases, fetal death. In the U.S. alone, RhD incompatibility occurs in more than 10% of all pregnancies, translating into more than 400,000 cases of RhD incompatibility annually.

“This collaboration marks a significant milestone in our strategy to commercialize non-invasive prenatal diagnostic tests and we believe Lenetix’s quality reputation and established position in prenatal testing will provide a solid foundation for our market entry,” said Harry Stylli, PhD, president/CEO of Sequenom. “We expect physician and patient adoption of the RhD test could pave the way for greater acceptance of our broader portfolio of non-invasive prenatal diagnostic tests in development.”

iCardiac Technologies (Rochester, New York) said it has entered into a multi-year research alliance with Pfizer (New York) to develop and validate advanced ECG-based cardiac safety biomarkers using the COMPAS technology platform.

iCardiac will receive an equity investment and technology license payment, plus research and development funding over the term of the alliance. The company will retain commercial rights to the validated technology platform and new biomarkers for future application in cardiac safety clinical trials and technologies.

The COMPAS technology was developed within the University of Rochester’s Heart Research Follow-Up Program (HRFUP) — a group of electrocardiology researchers focused on the ventricular repolarization process of the heart — and exclusively licensed to iCardiac.

The aim of the research alliance is the further development of iCardiac’s COMPAS platform and advanced ECG markers for use in the safety testing of in-development and on-market drugs, and includes a cross-licensing arrangement by which iCardiac will receive rights to ECG analysis technologies developed within Pfizer.

Under the terms of the agreement, iCardiac and Pfizer will collaborate on a research program comprised of a series of studies, including retrospective and prospective ECG data analyses.

The long-term goal of the alliance is to improve the precision, increase the speed and reduce the costs of cardiac safety clinical trials. Cardiac safety remains one of the most challenging hurdles in the development of new chemical entities and biotechnology-derived products.

As part of its Critical Path Initiative, the FDA has said that there is a significant opportunity to further improve the cardiac safety testing process and identify better markers of cardiac risk.

Dr. Jean-Philippe Couderc, iCardiac’s chief technology officer and the assistant director of HRFUP, said, “In parallel with the collaborative research on currently identified advanced ECG-based markers of cardiac risk, iCardiac and HRFUP will continue to advance its other research, development and validation programs to discover novel ECG-based biomarkers and to enhance the software technology platform to enable the use of the advanced ECG biomarkers in clinical trials.”

The Heart Research Follow-Up Program at the University of Rochester Medical Center is a leader in the science of cardiac arrhythmias and a genetic condition associated with an abnormal QT interval called Long QT Syndrome.

In other agreements news, Sonic Innovations (Salt Lake City), a producer of digital hearing aids, said that it has entered a supply agreement with Amplifon Group (Milan, Italy), making Sonic Innovations a preferred supplier to Amplifon for the first time in over five years. Under the supply agreement Amplifon has committed to selling a certain volume of Sonic product in selected geographic regions.

“This agreement reinforces our distribution expansion initiatives with key accounts with strong delivery networks. We are also very excited to have reengaged with the largest hearing aid distributor and retailer in the world,” noted Sam Westover, president/CEO of Sonic Innovations.

Amplifon Group said it is the world leader in the distribution and fitting of personal hearing solutions. Its North American subsidiary, Amplifon USA, is the parent company of the Sonus, Miracle-Ear and Amplifon Hearing Aid Centers brands.