December 5, 2017 | November featured news, products, and partnerships from around the diagnostics community from numerous companies, universities, and organizations, including Teladoc, Celmatix, ANGLE, and more.
Teladoc announced a proposed offering of shares of its common stock, which includes 3,250,000 shares offered by Teladoc and 830,000 shares offered by certain stockholders of Teladoc named in the preliminary prospectus supplement (the “selling stockholders”). The underwriters have a 30-day option to purchase up to an additional 612,000 shares of common stock from Teladoc. The proceeds of the primary portion of the offering will be used by Teladoc to prepay borrowings outstanding under its senior secured term loan facility. The remaining proceeds of the primary portion of the offering will be used by Teladoc for working capital and general corporate purposes. Teladoc will not receive any proceeds from shares of common stock to be sold by the selling stockholders. J.P. Morgan, Jefferies, and Piper Jaffray & Co. are acting as joint book-running managers for the offering. William Blair is acting as co-manager for the offering. Press release
Celmatix announced that the Fertilome genetic test has received full regulatory approval by the New York State (NYS) Department of Health (DOH) Clinical Laboratory Evaluation Program (CLEP). The Fertilome test is the first multigene panel test for reproductive conditions to be approved by NYS, which is known for having the most stringent requirements of the state agencies that regulate laboratory developed tests (LDTs). LDTs are not currently regulated by the FDA. Announced in January 2017, the Fertilome test has already been ordered for hundreds of women by over 80 reproductive specialists and OB-GYNs in the U.S. through a pre-approval program administered by NYS. The test offers physicians genetic insights into how a woman’s DNA may be impacting her reproductive health in sub-clinical ways that may not be apparent through traditional fertility tests that interrogate hormone levels. The test was developed after seven years of research. Celmatix scientists combined insights from over 1.1 million data points from more than 5,000 published clinical studies with findings from thousands of functional studies. This big data analysis resulted in the identification and statistical validation of 49 variants in 32 genes that have been associated with reproductive conditions that can impact a woman’s fertility including endometriosis, recurrent pregnancy loss, polycystic ovary syndrome, and early menopause. “We chose to launch in New York--the only state that requires that a test demonstrate both clinical validity and clinical utility to be eligible for approval--because from the beginning, we were committed to creating a test that is both clinically valid and useful,” said Piraye Yurttas Beim, Founder and CEO of Celmatix, in a press release. “We are very sensitive to the emotional and financial burdens on women considering egg freezing or undergoing fertility treatments. Personalized medicine, which leverages genetic insights about an individual to guide treatment and counseling decisions, is nascent in the field of reproductive health. Many genomics companies launch in New York State last or not at all because of the high bar set by the NYS DOH. We felt it was important, both to deliver peace of mind to our customers and also to set the standards high for the field, to hold ourselves to the highest standards from day one.” Press release
ANGLE announced that it has established a collaboration with Philips to develop liquid biopsy solutions. Philips has successfully secured a European Union research grant worth $8.48 million, of which $0.54 million will flow to ANGLE. Philips has selected ANGLE's Parsortix system as the sole system to be used for harvesting circulating tumor cells (CTCs) for analysis in the research collaboration, which is an important area of development for Philips following its restructuring in 2016 to focus on healthcare. The collaboration with Philips comes shortly after ANGLE's announcement of its co-marketing agreement with QIAGEN and is part of ANGLE's strategy to establish partnerships with a wide range of large companies for the commercialization of Parsortix. In the year to 31 December 2016, of Philips' total revenues of $32.94 billion, $23.53 billion came from healthcare, which is their focus for future growth. The collaboration is planned for a four year period. It is estimated that grant funding of $0.13 million and $0.27 million will be received by ANGLE in the financial years ending 30 April 2018 and 2019, respectively. The remaining $0.13 million will spread over the following three financial years. ANGLE Founder and Chief Executive, Andrew Newland, commented in a press release: "We are delighted to be working with Philips and the other commercial partners on the development of new liquid biopsy solutions. We look forward to joint commercialization of these solutions and to working closely with Philips going forward." Press release
eRAD announced that Canada Diagnostic Centres (CDC) will implement an array of eRAD software solutions, including eRAD RIS, Speech Recognition, Mammography Tracking, Patient and Physician Portals, and RADAR Nudge for secure communication. CDC is a long-standing provider of patient care in Western Canada and delivers sophisticated, multi-modality services to the community. After its previous RIS vendor sunsetted its product, CDC began a search for a solution that would take the practice into the future. In addition to selecting eRAD RIS, CDC will also implement RADAR Nudge—eRAD’s platform for HIPAA-compliant Instant Messaging—and other eRAD modules, including Speech Recognition, Mammography Tracking, and Patient and Physician Portals. Automated appointment reminders and patient self-scheduling are included in the solution, bringing greater service to CDC patients. “CDC performs more than 400,000 studies annually,” said Seth Koeppel, Senior VP of Sales at eRAD, in a press release. “They need a workhorse product that will also be able to scale as the future brings new possibilities. Our platform is robust enough to easily handle that volume, across multiple centers, and flexible enough to deliver the workflows that fit best with their needs, without any complexity. We’re delighted to welcome CDC to the eRAD family.” Press release
Results of a study from Washington University, St Louis, demonstrate that the DiviTum can evaluate the biologic activity of Pfizer’s breast cancer drug palbociclib (Ibrance) in just two weeks are published in the latest edition of the scientific journal Breast Cancer Research and Treatment. This shortening of the response evaluation window can improve outcome and increase quality of life for breast cancer patients. Led by Cynthia Ma, the study investigated 50 women with breast cancer treated with standard endocrine therapy in combination with Ibrance prior to surgery. DiviTum was used to measure cell proliferation rate in blood samples collected before and after 2 weeks of Ibrance treatment. Results demonstrate a high ability of DiviTum to identify each patient’s anti-proliferative effect of Ibrance. The researchers conclude that DiviTum can have a clinically useful role as an early indicator of treatment response to CDK 4/6 inhibitors such as Ibrance. “Our study provides the first clinical evidence of using DiviTum for measuring TK1 activity for early evaluation of the effect of palbociclib treatment in breast cancer. The results are very promising and support future studies of DiviTum to evaluate and identify patients for response to CDK 4/6 inhibitors,” says Cynthia Ma, Associate Professor of Medicine, Washington University School of Medicine, St Louis, US. There are currently three approved CDK4/6 inhibitors (Ibrance from Pfizer, Kisqali from Novartis, and Verzenio from Lilly) with documented ability to prolong disease progression. Far from all patients benefits from therapy, and can experience severe side-effects from a treatment priced at $ 10,000 per month. “These results correlating DiviTum to palbociclib efficacy are highly promising since there is no other blood based biomarker available for evaluating CDK 4/6 inhibitor efficacy today. CDK 4/6 inhibitors are very effective but also costly and far from all patients respond. It is therefore very important to provide new biomarkers in order to enable best possible treatments for patients and cost effectiveness for payers. These results support our aim to provide DiviTum as a standard tool for evaluating treatments in metastatic breast- and other cancers.” says Anders Rylander, CEO Biovica, in a press release. Press release
StatLab announced that it has acquired Lodi, California-based
American MasterTech Scientific. In a press release, StatLab CEO
Dan Eckert said, “The combination of American MasterTech’s portfolio of high quality stains and other laboratory products with StatLab’s extensive product portfolio and sales and distribution capabilities accelerates our ability to achieve our vision of being the partner of choice for anatomic pathology laboratories.” StatLab will operate American MasterTech as a wholly owned subsidiary out of its existing manufacturing facility in Lodi, CA, while providing future opportunities for customers to seamlessly access products from both companies.
Press release