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bioTheranostics Awarded Medicare Coverage for Breast Cancer Index Molecular Test

bioTheranostics, Inc., a leader in molecular diagnostics for cancer, recently announced that its Breast Cancer Index test has been awarded Medicare coverage. The Centers for Medicare and Medicaid Services posted a positive coverage and reimbursement policy after evaluation by Palmetto GBA, the Medicare administrator responsible for the MolDx molecular diagnostic technology assessment program.

bioTheranostics Receives Positive Coverage Decision and In-Network Provider Status from Tufts Health Plan for Its CancerTYPE ID Molecular Test for Metastatic Cancer

bioTheranostics, a leading provider of molecular diagnostic solutions for cancer, has received a positive coverage decision and in-network provider status from Tufts Health Plan for its CancerTYPE ID® molecular cancer classifier. Massachusetts-based Tufts Health Plan is one of the nation’s most highly rated health plans serving more than 1 million members.

CancerTYPE ID is a molecular cancer classifier that predicts tumor type in patients with metastatic cancers—among the most difficult to diagnose and treat cancers. Numerous clinical trials and economic analyses have been completed that reinforce the clinical validity and utility, prognostic performance, and cost-effectiveness of the test.

Richard Ding, president and CEO of bioTheranostics, said, “We are pleased that Tufts Health Plan is following Medicare and recognizing the value of the CancerTYPE ID test in the management of metastatic cancer. With metastatic cancer, achieving diagnostic certainty is critical to optimize site-directed therapies that reduce costs and avoid ineffective therapies for both patients and payors. This announcement is part of our efforts to work with payors across the country to make this important diagnostic test available to clinicians and cancer patients, helping to support personalized medicine with the goal of improving outcomes.”

CancerTYPE ID is becoming a standard tool in metastatic cancer management. More than 400,000 patients present with metastatic cancers in the United States each year. An accurate diagnosis of the site of origin is the first step toward personalized medicine, allowing clinicians managing these patients to treat them most effectively using site-specific therapy.

Source: Business Wire

Biodesix Secures Medicare Coverage for VeriStrat Test

Biodesix, Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, recently announced that Novitas Solutions, the Medicare Administrative Contractor for the region that includes Colorado, has established coverage for the company’s VeriStrat test. VeriStrat, a clinically validated blood-based protein test, helps physicians guide second-line therapy for patients with advanced non-small cell lung cancer (NSCLC). The coverage decision means that more than 49 million eligible Medicare enrollees in the U.S. will now be able to benefit from VeriStrat being a covered diagnostic test, according to specific lung cancer indications outlined by Novitas.

Lung cancer is the most common cancer worldwide, and is the leading cancer killer in both men and women in the United States. The five-year survival rate for lung cancer is roughly 15 percent, illustrating the need for predictive biomarker tests that can identify which therapies are most appropriate for individual patients. VeriStrat fills that role; the test was recently evaluated in a phase III clinical trial, with data presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting. Results confirmed that VeriStrat is predictive of differential treatment outcomes for the two types of therapies used in second-line treatment of advanced NSCLC: chemotherapy or the targeted drug erlotinib (Tarceva®).

Erlotinib, an EGFR inhibitor, is the drug most commonly used in patients who harbor an EGFR mutation. However, only a small percentage of patients have this mutation. The VeriStrat test helps oncologists guide treatment decisions between erlotinib and single agent chemotherapy in advanced lung cancer patients who do not harbor an EGFR mutation or whose mutation status cannot be obtained. VeriStrat requires only a simple blood draw and test results are returned in less than 72 hours, allowing physicians to make quick treatment decisions.

“Medicare’s decision to offer VeriStrat as a covered benefit will allow those patients enrolled in Medicare to benefit from better-informed, personalized decision-making when it comes to the treatment of their disease,” said David Brunel, Chief Executive Officer of Biodesix. “This is a major milestone for both Biodesix and for patients with lung cancer. Using the information from VeriStrat test results, physicians can improve patient outcomes by identifying the best course of treatment.”

Medicare’s positive coverage decision for VeriStrat, published in Novitas’ “Biomarkers for Oncology” Local Coverage Decision (LCD), describes multiple predictive and prognostic biomarkers in multiple tumor types. VeriStrat is included in the non-small cell lung cancer (NSCLC) section.

Saladax Receives CLIA Laboratory Certification and Approval to Begin Clinical Laboratory Operations in Support of MyCare Portfolio

Saladax Biomedical, Inc., a privately held company developing novel diagnostic tests that individually optimize a patient’s exposure to chemotherapy, today announced it has been certified as a registered CLIA Laboratory from the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans. The CLIA certification and approval marks a significant milestone for Saladax, allowing the company to begin clinical laboratory operations for the MyCare™ portfolio of products at its facilities located in Bethlehem, PA.

Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, Inc., will initially offer testing services for chemotherapy exposure optimization assays including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. SBL’s menu of testing services will expand to include more than a dozen new exposure optimization tests that are currently in development.

“This is a significant milestone for SBL as our CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests that we believe give cancer patients the edge they need with their therapy,” said Mark Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc. “The SBL team did an outstanding job preparing our company for this milestone and it is illustrative of their preparedness for the commercial launch of the MyCare portfolio to oncologists in the U.S.”

Beginning on July 1, 2013, SBL will offer testing services for their initial chemotherapy exposure test portfolio, MyPaclitaxelTM, MyDocetaxelTM and the My5-FUTM test (previously OnDose) that is being transitioned from Myriad Laboratories. The MyCare technology platform offers, rapid, robust and cost-effective blood tests for patient-specific chemotherapy dose optimization.

As a simple blood test, MyCare products will provide oncologists with vital information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.

About Saladax Biomedical, Inc.
Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. The company’s proprietary line of MyCare™ assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. The initial focus of Saladax is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. The initial portfolio of three assays is currently offered to the oncology community in markets around the world.

The company’s MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.

Source: Saladax Biomedical

Firm Hopes Big Data Can Personalize Health Care

When Colin Hill’s father was diagnosed with later-stage prostate cancer last summer, he was treated the same as every other patient with the illness.

This standardized approach bothered Hill, who believes medicine should approach each patient’s illness as unique, with medication tailored to the person’s history and biology.

“You show up to the hospital, and it’s like Groundhog Day,” Hill said, with patients being cared for the same way, over and over again. “It’s this outdated standard of care created for this hypothetical average patient. But no one’s an average patient.”

A genetic analysis of the tumor in his 69-year-old father, Foster Hill, found he had a genetic variant of the cancer that does not usually respond well to the hormone therapy Lupron, the current standard of care. But not knowing what else would work, doctors gave Foster Hill Lupron anyway. Luckily, the treatment seems to be helping, and his father’s outlook is much improved.

Hill hopes a Kendall Square company he founded 13 years ago, GNS Healthcare, will eventually improve medical care for his father — and for countless others — by providing personalized treatment. GNS is among the leaders in using Big Data analytics to learn more about diseases, patients, and treatments.

With data from thousands of cases, GNS uses artificial intelligence to determine what treatment made the crucial difference for each patient.

The company is deploying enormous computing power to produce a more complete understanding of treatments for rheumatoid arthritis, diabetes, cancers, and other illnesses.

For example, it is working with the Dana-Farber Cancer Institute and Mount Sinai Medical School to build a computer model of multiple myeloma, so researchers can better understand what works well for patients today, as well as develop more effective treatments for the blood cancer. It is involved in a similar collaboration with Brigham and Women’s Hospital and several other partners to learn more about multiple sclerosis.

Harvard Medical School recently agreed to use a GNS computing platform to analyze how cells replicate or transform into different types, for insights into­ conditions such as cancer and neurodegenerative diseases, Hill said.

And the company has a partnership with the Centers for Medicare & Medicaid Services and Health Services Advisory Group to assess health care quality measures, as well as other recent deals with pharmaceutical companies, hospitals, and advocacy groups, and the insurance giants Aetna and Blue Cross Blue Shield.

“It’s exciting times for us,” Hill said, after 13 years of developing his approach to analyzing health care. “We are now in the thick of things.”

Hill did not always have such an absorbing interest in science. He went to college at Virginia Tech — mainly to play tennis. “I was more serious than I was good,” he quipped.

But while there, he became fascinated by physics and chaos theory — the idea that complex patterns could result from simple rules.

His imagination was stoked by a summer job in 1996 at Santa Fe Institute, an interdisciplinary research center focused on highly complex issues. Hill then went on to graduate from McGill and then Cornell University.

By then, the Human Genome Project was becoming a reality, capturing the attention of many scientists, including a young Hill.

“That’s when two and two came together,” Hill said. “It was like ‘Oh yeah, the stuff we’re doing, though it’s pretty theoretical, it is going to be the thing that links these pieces together,’ ” including chaos theory, genetics, Big Data, and health care.

Now he’s in the middle of the so-called Big Data revolution in health care. Companies such as GNS have an enormous capacity for crunching troves of information on patients, diseases, and medical outcomes collected by medical providers, insurers, and other big players.

Hill likes to say he wants GNS to capture the “data exhaust thrown off” by every interaction a patient has with the health care system, from the doctor’s office to the hospital to the pharmacy. A bad reaction to medication is a data point worth having; ditto for other side effects, as well as results of all kinds of procedures and interventions — bad or good.

While such data sets are getting easier to find, Hill said, genetic information is still too expensive to be truly useful.

“What we don’t have yet for my dad and for other men with prostate cancer is a large coherent set of data on prostate cancer patients that includes the molecular level,” Hill said.

With information aggregated from thousands of cases, Hill said, GNS uses artificial intelligence algorithms developed out of chaos theory to determine what treatment made the crucial difference for each patient, and with it what is likely to work best for the next patient — rather than simply trying one medication after another, as is often done today.

“What we’re trying to get at is not just patterns and trends, but reverse engineer the mechanisms that gave rise to the data,” he said. “We’re trying to find the cause-effect relationships within the data.”

This ability to predict results is what sets GNS apart, said Dr. Atul Butte of Stanford University, one of the academic leaders of the Big Data movement. That’s the “nifty part of their technology,” Butte said.

Alexis Borisy, a partner at the Boston life sciences venture capital firm Third Rock Ventures, said GNS is in the vanguard of Big Data companies analyzing health care information.

“They’ve had a chance to learn, refine, and they’ve kept with it so they’ve had a lot of experience to build on,” Borisy said.

He and Hill have known each other since they were young business executives more than a decade ago, and he said he has tremendous respect for Hill’s intelligence, persistence, and communication skills.

“He is one of the visionaries in the space,” said Borisy, who also serves as chairman of Foundation Medicine, a molecular information company, and interim chief executive of Warp Drive Bio, both of Cambridge. “I think it’s fair to say he’s kept GNS growing and building by the force of his personality and the force of his efforts.”

Source: The Boston Globe