by April Dembosky in San Francisco

Olympic athletes are giving up their personal physical data in exchange for the latest gadgets that record sleep, diet and exercise patterns as they try to boost their performance in this year’s games.

Several health technology companies plan to use the athletes’ data to help re-engineer the tracking devices and later reposition the products for the amateur sports performance market or the $61bn weight loss market.

“These are early-phase trials to see how it works,” said Kevin Sayer, president of DexCom, which has donated its continuous glucose monitors to several US athletes. “We’re open to learn.”

Many of the technologies have been developed since the last Olympics and executives at a number of health-tracking companies are looking to the London games to increase their exposure.

Members of the US track cycling team are using the glucose monitor, used primarily by diabetics to help manage blood sugar, together with a sleep monitor from Zeo and genetic reports from Pathway Genomics that indicate nutritional needs and muscular capacity.

“It’s all connected,” said Sky Christopherson, a consultant to the team members and founder of the Optimized Athlete, a start-up that analyses patterns in personal health data.

He uses athletes’ sleep data to improve race times. For example, he discovered there was an optimum amount of deep sleep associated with more powerful performances on the bike track.

In an attempt to increase the athletes’ deep sleep, they studied their blood sugar and recommended night-time snacks that did not cause big fluctuations in the levels. With better sleep, the athletes had better workouts.

Most of the athletes experimenting with the devices are very secretive about it but are willing to donate their data to the companies’ expansion efforts.

“Olympic athletes are on the leading edge of performance. You can expect perfect compliance, which leads to perfect data,” said Ben Rubin, chief executive of Zeo, the sleep tracking device. “We seek to understand their sleep first, then trickle those findings down to everyday athletes and ordinary folks.”

By Allison Proffitt

Pathway Genomics has launched its BRCA True test for BRCA 1 and BRCA 2 and its BRCA One for One program, hoping to offer the industry’s best BRCA genetic test and make it accessible to a wide range of women.

The company believes the One for One program to be rare in health care. “We thought a lot about it and we talked to a lot of global patient advocacy organizations and we thought… for every test that was ordered, we can donate a test to someone in need,” Ardy Arianpour, Chief Strategy Officer for Pathway Genomics told Bio-IT World.

Pathway is partnering with eight advocacy groups representing an international patient population: Susan G. Koman for the Cure, Bright Pink, Living Beyond Breast Cancer, National Ovarian Cancer Coalition, Young Survival Coalition, Foundation for Women’s Cancer, Facing Our Risk of Cancer, and Sharsheret.

HEALTH: Alliance Is Formed With Large Medical Records Firm
By MEGHANA KESHAVAN

San Diego’s Pathway Genomics has been ramping up its presence in the field of personalized genomics, as evidenced by its most recent collaboration with Practice Fusion Inc., a San Francisco-based electronic health record developer.

“The field of genetics is rapidly growing, but the question is — how can we get all this information to physicians as quickly as possible?,” said Michael Nova , Pathway Genomics’ chief medical officer. “Through electronic interfaces. Through electronic health records.”

Inputting genomic data into electronic health records is a goal for many electronic medical record providers, as personalized medicine advances allowing physicians to tailor-fit drugs based on a patient’s genes. By examining DNA from a person’s saliva, or in some cases blood, Pathway Genomics screens specific genes and provides information that relates to genetic disease, traits that impact heart health, possible drug response, nutrition and exercise response, as well as common health conditions.

‘Critical Step’

“Our mission, and medical responsibility to the community, is to provide people with actionable and accurate genetic information they can use to maintain health and wellness,” Nova said. “Integrating our lab services into Practice Fusion’s EMR platform is a critical step in making this actionable genetic information more accessible to the physician, and ultimately, the patient.”

Founded in 2005, Martin said Practice Fusion provides a free, Web-based electronic health record application to physicians. Physician practices, often burdened with the mounting expenses of integrating costlier electronic health records into their day-to-day routine, can input their patients’ most vital information and easily track patients’ health trajectory.

Pathway Is the First

Practice Fusion boasts a network of about 150,000 medical professionals and about 60 million patients on the platform, and Pathway is the first genomic testing company to be listed among Practice Fusion’s more than 200 laboratory services vendors. “Reporting on a person’s genetic information is a critical ingredient in delivering highly personalized medical care to physicians and their patients,” said Todd Martin, Practice Fusion’s senior vice president of business development.

One avenue that Pathway will no longer pursue is direct-to-consumer testing, said Todd Johnson, Pathway Genomics’ chief commercial officer. The company previously dabbled in the wider personalized genomics market, announcing in 2010 a saliva collection kit that could be sold at Walgreens. A buyer could potentially purchase a test to determine his or her predisposition to genetic diseases or drug reactions. But the U.S. Food and Drug Administration wasn’t prepared to allow a widely commercialized, over-the-counter genetics test, so Pathway Genomics rerouted to focus on research and physician-centric approaches.

Working With Blue Shield

This direction shift has proven effective: Earlier this year, Pathway Genomics announced it joined Blue Shield of California’s Preferred Provider Network, which consists of an HMO network of more than 34,000 physicians and 290 hospitals, and a PPO network that includes more than 60,000 physicians and 351 hospitals.

It services about 3.3 million patients, and Pathway Genomics will be able to provide genetic testing to those in the network who need it.

Additionally, Pathway Genomics is currently involved in a large clinical trial. Launched last summer, researchers at the Veterans Affairs San Diego Healthcare System began a clinical trial aimed at improving the health of obese veterans and focusing on the genetic associations of weight-loss and weight-regain.

Genomic and health record integration can be critical for medical research, said Joshua Denny, a biomedical informatics professor at Vanderbilt University who authored a paper about data-mining electronic health records.

Denny is a key participant in the government’s Electronic Medical Records and Genomics (eMERGE) Network, along with several research institutions around the country. The goal of eMERGE, which was formed in 2007 by the National Institutes of Health, is to study ways to integrate genomics with patient record data to create a more efficient and effective way to conduct research.

Researchers and physicians alike can use genomics information in health records to cut research costs by allowing several studies to be conducted on one individual, Denny said. He said that EHRs offer “a rich, real-world dataset that requires little additional funding to obtain.”

“The EHR model for genetic research offers several key advantages,” he said. “A primary advantage is cost.”

By Bradley J. Fikes

SAN DIEGO, CA – June 3, 2014 – Taking advantage of last year’s Supreme Court ruling against many gene patents, Pathway Genomics Corp. said Tuesday it has started selling a test to detect mutation in genes associated with breast cancer and other malignancies.

The test is ordered by doctors and performed in Pathway’s certified laboratory.

Pathway Genomics’ test spots aberrations in the “BRCA” genes known for heightened risk of breast and ovarian cancer. Mutations also increase the risk of prostate, breast and skin cancer in men.

Last year, actress Angelina Jolie underwent a double mastectomy after testing revealed she had a particularly dangerous BRCA mutation.

Jolie took the test because there is a history of cancer in her family. Jolie’s test was provided by Myriad Genetics, a Salt Lake City biotech which held a legal monopoly on the BRCA test until the Supreme Court ruling. That ruling said gene sequences existing in nature cannot be patented. It opened the way to competitors, now including San Diego’s Pathway Genomics.

Shortly after the court’s ruling on June 13, Pathway said it would enter the BRCA testing business. Another competitor, Ambry Genetics of Aliso Viejo, began offering the test on the day of the decision. In March, a federal judge rejected Myriad’s request for a preliminary injunction to stop Ambry’s service.

BRCA testing has been lucrative for Myriad. In years past, the company’s BRCA tests have brought in about 80 percent of its revenue. In the fiscal year ended June 30, Myriad took in overall revenue of $613 million.

Myriad charges nearly $4,000 for its test. Pathway Genomics is charging $1,800 for its BRCA True test, said Ardy Arianpour, the company’s chief strategy officer. Results are available in 14 calendar days, he said.

For people who don’t have health insurance or otherwise can’t afford the test, Pathway Genomics
said it’s donating up to $10 million in free testing. For every qualifying test ordered, one will be
donated, according to the company.

There are two BRCA genes, BRCA1 and BRCA2. Mutations in these genes have long been known to be associated with breast and ovarian cancer in women, and breast, prostate and skin cancer in men. A study released Sunday found a link between a BRCA2 mutation and increased risk of lung cancer in smokers. The risk is about 25 percent, nearly double the risk of smokers who don’t have the mutation.

Like Myriad’s test, Pathway’s BRCA True covers both BRCA genes. The Pathway test covers 18,000 base pairs, or “letters” of the DNA alphabet, Arianpour said.

However, Myriad said its database of significant BRCA mutations — which is not affected by the Supreme Court ruling — makes its testing more accurate than that of competitors. That’s because some mutations carry a higher risk of cancer than others. Myriad keeps the database confidential as a trade secret.

By Allison Proffitt

Pathway Genomics has launched its BRCA True test for BRCA 1 and BRCA 2 and its BRCA One for One program, hoping to offer the industry’s best BRCA genetic test and make it accessible to a wide range of women.

The company believes the One for One program to be rare in health care. “We thought a lot about it and we talked to a lot of global patient advocacy organizations and we thought… for every test that was ordered, we can donate a test to someone in need,” Ardy Arianpour, Chief Strategy Officer for Pathway Genomics told Bio-IT World.

Pathway is partnering with eight advocacy groups representing an international patient population: Susan G. Koman for the Cure, Bright Pink, Living Beyond Breast Cancer, National Ovarian Cancer Coalition, Young Survival Coalition, Foundation for Women’s Cancer, Facing Our Risk of Cancer, and Sharsheret. “The patient advocacy groups did tell us that a lot of people came to them saying, ‘I don’t have the money, but I want to get this testing… can you help us?’” Arianpour said.

Pathway Genomics tests are ordered by and returned through a physician. Samples are gathered by the patient’s doctor, and sequencing and analyses are done in Pathway’s CLIA-certified labs. For every test ordered and paid for through a physician, Pathway will offer a test free of charge to advocacy organizations to distribute. “We’re not picking and choosing [patients],” Arianpour said. “We want this to be an open access program.”

The One for One program is limited to $10 million worth of free testing, and the BRCA True test costs $1,799; that’s almost 5,600 free BRCA tests. (Myriad Genetics’ BRCA test costs about $3,000 to $4,000.)

The test itself—Pathway’s BRCA True test—took the company over a year to design, Arianpour says, and returns results within 14 calendar days. The saliva-based next-generation sequencing test and deletion/ duplication analysis looks for mutations in both BRCA1 and BRCA2 and performs with a sensitivity of over 99.99%. “Our coverage on the BRCA gene is far greater than any other laboratory offering BRCA testing,” he says. Arianpour says Pathway expects—and is prepared-to be “flooded with samples” from both ordering physicians and the One for One program. “Pathway has the capacity and scalability of running thousands of samples a day,” he says, and relies heavily on robotics for sample handling. (The company currently runs thousands a week.) “We were built from the start to handles massive amounts of samples.”

Instead of a challenge, Arianpour sees the coming swell of samples as a boon to research for Pathway and the breast cancer community as a whole. “We’re going to get some amazing data,” he says. The wealth of data will be crucial for research and will help in “getting the lowest VUS [variants of unknown significance] rates.”

Arianpour says the company is happy to be able to offer testing to women who couldn’t otherwise get it, and hopes the One for One program will provide an avenue for more testing internationally of traditionally underserved demographics.

“It’s not just about having some cheap price on a test. It’s about doing as much testing as possible,” Arianpour said. “We’ll be able to do testing with the BRCA One for One program [for women] who have never been tested in certain demographics.”

As Pathway Genomics is active in the Free the Data movement, Arianpour said, the company will deposit its data in ClinVar.

As with any mention of BRCA testing, Myriad Genetics and the company’s gene patents immediately spring to mind. Arianpour declines to comment on the topic in general, but does offer a prepared statement about gene patents:

“As you know, the viability and enforceability of patents relating to BRCA 1 and B RCA 2 testing have been in question for some time. In the last few years, we’ve seen the Supreme Court strike down a number of these patents. More recently, at least one district court has explicitly expressed its view that the validity of these patents will not withstand judicial scrutiny. As a company, we have taken a prudent approach to this matter, and we are confident that we do not infringe any valid claim.”

By Meghana Keshavan

San Diego’s Pathway Genomics Corp. has launched test that detects a genetic mutation that causes breast cancer, benefitting from a Supreme Court ruling last year that invalidated patents on genes.

The test, called the BRCA True, detects the presence of a gene mutation found among families that have multiple cases of the disease. A Salt Lake City-based company called Myriad Genetics Inc. held a patent on tests for the genes, called BRCA1 and BRCA2, stymieing other companies from developing tests for these genes.

But the Supreme Court ruled in April 2013 that the patents on the BRCA genes – or any genes – were invalid, opening up the market for companies such as Pathway Genomics to provide such tests.

Pathway Genomics said the BRCA True has a sensitivity of higher than 99.99 percent. To make the test more accessible, it has offered that for every tests that is ordered, one will be donated to a person in need through patient advocacy organizations – up to $10 million in free testing.

“One out of every eight women will be affected by breast cancer in her lifetime,” Ardy Arianpour, Pathway Genomics’ chief strategy officer, said in a statement. “By making our test more accessible, we aim to make a substantial impact in the prevention of breast cancer and help further raise awareness by partnering with global patient advocacy organizations.”

This issue came into the media spotlight last year when actress and activist Angelina Jolie announced she had received a double mastectomy after learning she carried the genetic mutations that predisposed her to breast cancer.

BIOTECH: Supreme Court Ruling on Gene Patent Case Clears Path to Competition
By MEGHANA KESHAVAN

San Diego’s Pathway Genomics Corp . is employing a social entrepreneurship model as it launches its new genetic test for breast cancer — entering a market made more high profile and competitive after a U.S. Supreme Court ruling last year that invalidated patents on genes.

For every breast cancer test ordered by a physician, Pathway will donate another to a woman in need through philanthropic organizations like Susan G. Komen for the Cure. The company plans to give away $10 million in free testing, or about 5,500 tests.

The test, called the BRCATrue, detects the presence of a gene mutation found among families that have multiple cases of the disease. A Salt Lake City-based company called Myriad Genetics Inc. held a patent on tests for the genes, called BRCA1 and BRCA2, and its monopoly stymied other companies from developing tests for these genes.

But the Supreme Court ruled in June 2013 that the patents on the BRCA genes — or any genes — were invalid, opening the market for companies such as Pathway Genomics to provide such tests.

This issue came into the media spotlight last year when actress and activist Angelina Jolie announced she had received a double mastectomy after learning she carried the genetic mutations that predisposed her to breast cancer. She vocally advocated greater accessibility for BRCA testing; soon after, the Supreme Court ruling was announced.

“After that happened, we accelerated our development on the hereditary breast cancer test,” CEO Jim Plante said. “And while we’re not the only test on the market, we think ours is the best.”

It’s a large and growing market: About 85 percent of Myriad’s fi scal 2013 revenue of $613.2 million came from BRCA testing. At the time, Myriad was charging more than $3,000 for these breast cancer tests. In the year since the ruling, Pathway has brought down the cost considerably, offering the BRCA testing for $1,799. Quest Diagnostics Inc., the largest player in the testing space, offers its most comprehensive version of a BRCA test for $2,500. It has been on the market since last October.

Pathway is differentiating itself from competitors like Myriad and Quest with its offer to donate $10 million in free testing; it also offers free genetic consultation with all of its testing, providing information about genetic testing — before and after it’s taken — for physicians and patients. Pathway Genomics said the BRCATrue has a sensitivity of higher than 99.99 percent. The company boasts the fastest testing turnaround time, promising results within 10 business days, Plante said.

“One out of every eight women will be affected by breast cancer in her lifetime,” said Ardy Arianpour, Pathway Genomics’ chief strategy offi cer. “By making our test more accessible, we aim to make a substantial impact in the prevention of breast cancer and help further raise awareness by partnering with global patient advocacy organizations.”

The company has been developing tests for hereditary cancers for two years, and plans to expand further into this market, by potentially offering tests for colorectal, lung and prostate cancers.

“In the near term, we plan to launch tests that cover all the cancers that have high prevalence rates,” Plante said.

NEW YORK (GenomeWeb) – Pathway Genomics this week launched a next-generation sequencing test for gauging alterations in BRCA 1 and BRCA 2 genes, called BRCA True, and a patient assistance program through which it is offering free testing to women in need.

The non-invasive, saliva test, according to Pathway, has a sensitivity of greater than 99.99 percent. It uses NGS to gauge mutations in the coding regions of the genes of interest and confirms the findings by Sanger sequencing. Using quantitative PCR assays, the test gauges large deletions and duplications with BRCA1/2 and confirms the results by array comparative genomic hybridization.

BRCA True reports one of three results about a detected BRCA alteration in a patient: pathogenic, likely pathogenic, and uncertain pathogenicity (deemed a variant of unknown significance or VUS). Pathway doesn’t report likely benign or benign results. A sample test report can be viewed here.

According to Ardy Arianpour, chief strategy officer at Pathway, the company is able to deliver test results within 10 business days and has a VUS rate of less than 5 percent. Pathway’s CLIA-certified and CAP-accredited lab will perform the testing.

Simultaneous with the test launch, Pathway also announced the BRCA One for One program, through which the company pledges to perform a free BRCA test for a woman in need for every “qualified” BRCA test conducted. Pathway’s internal genetic counselors or patients’ doctors will determine whether they are “qualified” for testing according to breast cancer risk screening guidelines. The list price of the test is $1,799.

“Our mission is to ensure that people that are in need of receiving genetic testing regardless of their economic or insurance status can get this test,” Arianpour said. Pathway has allocated $10 million toward performing free testing through the One for One program for the next two years. The company will partner with patient groups to identify the women who lack access to testing.

By offering free testing, Pathway is also hoping to extend this resource to underserved populations and improve knowledge about the prevalence and disease associations of BRCA1/2 alterations in the overall population.

“National patient advocacy organizations have access to a lot of women in certain demographic groups who haven’t been able to get access to testing,” Arianpour said. “There are women who have contacted those advocacy groups saying, ‘I don’t have the money or I don’t have insurance to access these tests. How can I get it?’”

With growing competition in the BRCA testing space, diagnostics firms such as Ambry Genetics, InVitae, Quest Diagnostics, LabCorp, and Myriad Genetics are trying to one up each other on the price, turnaround time, accuracy, and depth of coverage of their tests. With the introduction of panel testing, a matter of growing importance is a test’s VUS rate – the proportion of results identifying variants with unclear association to disease.

Providing free testing for underserved populations will help Pathway perform more testing and improve the VUS rate for BRCA True. “A lot of ethnic groups can’t get the test,” Arianpour said. “We’re not only going to be able to get more data for every test that’s ordered but at the same time help a human and a family in need.” Pathway already performs complementary testing for family members of women who have a VUS result through its familial studies program.

Similarly, Myriad conducts free testing for family members of those with VUS results, and boasts a VUS rate of below 2 percent. The company last year expanded its financial assistance program for underinsured patients, lowering the out-of-pocket costs for all of Myriad’s tests to no more than $375. To be eligible, patients must have private insurance, meet their insurers’ coverage criteria for testing, and have a household income that does not exceed 200 percent of the Federal financial poverty level.

Unlike Myriad, however, Pathway and most other BRCA testing providers are contributing de-identified test data to ClinGen, an-NIH funded effort to build a public, annotated database of genomic variants using standardized classification methods. The aim of this effort is to lower the VUS rate of variants across the genome for various illnesses.

However, all the companies in the BRCA testing space, whether they are part of ClinGen or not, recognize the need to reduce VUS rates as adoption of NGS-based hereditary cancer testing increases. Studies of multi-gene panels by Myriad, Ambry, InVitae, and others suggest the panels increase the diagnostic yield by about 10 percent over more targeted tests, but these tests also have higher rates of VUS and find markers not included in clinical guidelines.

Memorial Sloan Kettering Cancer Center along with other academic research institutions recently announced the launch of PROMPT, a registry that will store and curate rare gene variants increasingly detected by genetic testing panels. The researchers will gather information on the genes of interest through participating labs, including Ambry and Myriad.

By Turna Ray

The approximately 150,000 doctors using Practice Fusion’s web-based electronic medical records services will now have access to genetic testing offered by Pathway Genomics.

In its latest move to expand its direct-to-physician genetic testing services, Pathway Genomics inked a partnership with Practice Fusion, a company that markets free online EMR software to help doctors keep track of information about their patients, including medical charts, e-prescriptions, lab test results, and referrals.

Under the terms of the deal, Pathway Genomics will be listed in Practice Fusion’s laboratory database but Practice Fusion will not market Pathway’s genetic testing services to doctors. “They’re not selling for us,” Todd Johnson, Pathway’s chief commercial officer, told PGx Reporter. Rather, “we will be able to take an order and we will be able to send the reports electronically through Practice Fusion’s database and interface.”

As a direct-to-physician testing service, Pathway independently markets and educates physicians about its genetic testing services.

Practice Fusion offers its physician customers a “lab integration solution” through which practices can receive test results that are reported back electronically to a specific patient’s chart. In this way, doctors who choose to genetically test a patient using Pathway’s services will be able to receive the test results electronically within a patient’s record.

“This is our first opportunity to bring genomic test results into our EMR ecosystem,” Todd Martin, Practice Fusion’s senior VP of business development, told PGx Reporter. “This is important especially as drugs become more specialized and genetic targeting for effectiveness becomes a bigger factor in treatments.”

Pathway offers genetic tests that doctors can use to get additional information about their patients’ cardiac conditions; to gauge if patients are likely to respond to or experience adverse reactions to a drug; to assess how patients’ genes influence their response to diet, nutrition, and exercise; to help those interested in having children learn of heritable conditions they might pass on; and to determine if patients have a heighted genetic risk for certain serious illnesses.

A number of personalized medicine advocates have argued that in order for genetic tests to be used more broadly by doctors in medical practice, the results have to be stored in patients’ medical records so the information is accessible at the time of care and then over the continuum of their care. By collaborating with Practice Fusion, Pathway is aiming for just that.

“EMRs in general allow companies, such as [Pathway], to connect digitally with physicians, and deliver reports electronically and hopefully, one day, be able to receive orders through Practice Fusion electronically, and so have a true bidirectional interface,” Johnson said.

By offering its genetic testing services through an EMR provider, Pathway is hoping that doctors will be able to use genomic testing information more efficiently in patient care. “What this is going to do for physicians … is increase productivity, decrease the amount of time spent on paper requisitions, and be able to allow physicians to have the opportunity to spend more time with more patients,” Johnson noted. “And that’s going to be the name of the game, especially with … changes” due to healthcare reform.

Under certain provisions of the Affordable Care Act, physicians will have to meet certain quality metrics and reduce the total cost of patient care. This will require doctors to figure out ways to use their limited time with patients more efficiently and prescribe treatments that are cost- effective and improve outcomes.

Genomic information on a patient can help guide treatment strategies while considering both costs and outcomes. For example, testing cardiac patients who have undergone a stent procedure for mutations in CYP2C19 genes can reveal whether they are poor responders to the antiplatelet drug clopidogrel. Based on this information, the doctor can determine whether to treat the patient with a brand name antiplatelet drug or the generic clopidogrel.

“In the case of Pathway, and genomic testing in general, we’ve long known that this is an area of increasing importance when it comes to determining effective treatments and working with more specialized medicines,” Martin said. “Connecting Pathway Genomics to deliver results is just the first step but we are looking to expand our relationships with labs in the near future when we add lab ordering into the treatment workflow.”

Practice Fusion’s EMR is used by 150,000 medical professionals, who serve 60 million patients in the US. The San Francisco-based company, founded in 2005, claims it is the “largest and fastest growing online community of physicians and patients.” Most of the medical professionals using Practice Fusion’s services are independent doctors who work in small practices of nine or fewer doctors. Practice Fusion’s EMR system is intended for doctors who “find the exorbitant costs of other EMR systems to be prohibitive … even [after] taking government incentives into account,” Martin noted.

The collaboration between Pathway and Practice Fusion comes as the EMR services provider is becoming more interested in helping doctors deliver personalized care to patients. In February, Practice Fusion acquired 100Plus, a personalized health prediction startup that develops apps that can track how small behavior changes among patients impact their wellness.

“Increasingly, personalized medicine has become a bigger part of the healthcare equation,” Martin said. “The genomic testing performed by labs such as Pathway is becoming a big factor for doctors as they seek the best treatments for their patients,” Martin added. In line with Practice Fusion’s strategic direction, Pathway offers a test that analyzes 80 genetic markers associated with people’s metabolism and dietary traits, as well as their response to exercise. This nutrigenetic test, called Pathway Fit, is typically ordered by physicians to help obese patients manage their weight, learn more about patients’ metabolic syndromes, or provide patients with sports nutrition information.

Pathway is currently conducting a large prospective, randomized clinical trial with the Veterans Affairs San Diego Healthcare System to determine whether its nutrigenetic test can be used to help veterans make lifestyle changes that manage their weight. Although Pathway couldn’t discuss the detail of the trial due to confidentiality agreements with the VA, Chief Medical Officer Michael Nova noted the trial will be ongoing for between six months to one year. Veterans enrolled in the study will be genotyped using the Fit test and followed for a number of endpoints, including direct weight loss, Nova said.

Previously, Pathway collaborated with the California Schools Voluntary Employee Benefits Association to study whether the Fit test helped 179 overweight California school employees lose weight. After six months, overweight employees in the trial who were genotyped through the Fit test had “significant weight loss” compared to those who tried to lose weight without genetic information as a motivator. Some study participants who received genetic testing lost up to 40 pounds, according to Pathway.

The latest partnership with Practice is part of Pathway’s ongoing efforts to grow its visibility before physicians. Earlier this year, Pathway joined Blue Shield of California’s Preferred Provider Network, which will give physicians who use the provider access to the company’s tests, Johnson said. Blue Shield of California serves an HMO network of more than 34,000 physicians and 290 hospitals, and a PPO network of more than 60,000 physicians and 351 hospitals.

By Rhonda Reinhart

Pathway Genomics announced today the launch of BRCA True, a next-generation sequencing test that looks for mutations in BRCA1 and BRCA2, genes associated with breast and ovarian cancer. Along with the new test, the company also announced an accompanying One for One program to help people in need. Similar to the One for One program TOMS Shoes offers, in which the company donates a pair of shoes for every pair purchased, Pathway’s program will donate one BRCA True test for every test ordered.

Working with patient advocacy groups such as Susan G. Komen, Bright Pink, and the National Ovarian Cancer Coalition, Pathway Genomics will donate up to $10 million of free testing through the two-year program. The BRCA True test, which is covered by insurance and has a two-week turnaround time for results, costs $1,799. In addition to the One for One program, Pathway also offers a financial assistance program that patients can discuss with their physicians or with Pathway’s billing department directly.

Ardy Arianpour, Pathway Genomics’ chief strategy officer, says BRCA True is just the first of many genetic cancer tests the company plans to announce this year.

To discuss your own hereditary risk assessment, consult your physician, or call 877-505-7374 to speak to a Pathway Genomics genetic counselor.