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Veritas Genetics Enters BRCA1/2 Space with $199 Test

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NEW YORK (GenomeWeb) – Saying it wants to make genetic testing for cancer more widely available, startup Veritas Genetics recently launched its first test for BRCA1 and BRCA2 testing for $199, the first of what its CEO said will be several tests that the company will make available over the remainder of 2015 and beyond. 

The firm is making its test, called myBRCA, available without the need for insurance approval, though a physician requisition is needed. At $199, myBRCA costs a fraction of other BRCA1/2 tests, most notably Myriad Genetics' BRCA1/2 tests, which list for about $4,000. Additionally, for every paid myBRCA test performed, Veritas will donate another to a patient. 

Founded a year ago by George Church, Mirza Cifric, Preston Estep III, Joseph Thakuria, and Jonathan Zhao, the company's core mission is to make genetic testing available to the wider masses, Veritas CEO Cifric told GenomeWeb. 

"It would be shortsighted to say that [myBRCA] is just another lower-cost alternative to Myriad. Our premise and our purpose … is driven by access," he said. 

According to Cifric, Veritas set the price for the saliva-based myBRCA test last year after determining that $199 was the tipping point at which the test would be affordable on an out-of-pocket basis. Although the firm also considered charging $99, Cifric said that even at that price, some patients would not be able to afford it, so instead, Veritas chose the $199 price and to donate a free test for every fully paid test in order to make it accessible. 

In addition to getting the test performed, a report on the results, and a clinical interpretation of the results, a patient also has access to genetic counseling from Veritas. 

Promise to Feel 'Em, a grassroots effort advocating early breast cancer detection, will decide which patients receive free myBRCA tests. 

Cifric maintained that despite its low cost, myBRCA will be profitable, even with the donated tests, although he declined to disclose the profit margin on each test. He said that Veritas' proprietary technology allows the company to maximize its resources and the efficiency of its test, while costs associated with licensing or user fees also are kept to a minimum. "By owning and controlling proprietary technology, you can control the costs," he said. 

Veritas is positioning myBRCA as a screening test, though it also is exploring the test's potential as a diagnostic tool for breast and ovarian cancer and evaluating whether certain BRCA1/2 mutations are sufficient for diagnostic purposes. 

Cifric declined to provide details about Veritas' proprietary technology — which comprises both licensed methods and in-house developed technologies — saying only that it is based on targeted sequencing using Illumina's NextSeq 500 platform. However, he added that Veritas plans to publish studies describing its technology, and the ability of myBRCA to detect large insertions and deletions. 

"We have several pieces of proprietary technology that allow us to go after what we call difficult or intractable sequencing problems using NGS," he said.

Veritas launched myBRCA after completing a $10 million Series A financing round. Previously, the firm raised $2 million in seed financing. 

Breaking into BRCA testing 

The Boston-based firm enters the BRCA1/2 testing space at a time when the market continues to evolve, following the US Supreme Court's decision in 2013 that human genes are not patentable while synthetic DNA, or cDNA, is patent eligible. By nullifying some claims around BRCA1/2 genes held by Myriad, the court unlocked a market that the Salt Lake City-based company had monopolized, and after the ruling, a number of firms, including Quest Diagnostics, Bio-Reference Laboratories' GeneDx, and Invitae, launched BRCA1/2 tests.

As the dust continues to settle from the SCOTUS ruling, Myriad remains the leader in BRCA1/2 testing and claims to still hold a 95 percent share of the market. 

Part of its dominance can be attributed to its BRCA database for classifying variants. With more than 1 million test results, it remains the most comprehensive and reliable database for BRCA1/2 mutations, and especially in comparison with public databases, Myriad's tool allows the firm to provide test results with unmatched accuracy, according to Myriad spokesman Ron Rogers, who pointed to a study published earlier this year by company researchers that questioned the quality of BRCA1/2 mutation data contained in public databases. 

The researchers retrospectively analyzed more than 2,000 consecutive BRCA1/2 genetic variants identified from about 25,000 consecutive patient samples and compared the clinical classifications of the variants among five publicly accessible BRCA1/2 variant databases — Breast Cancer Information Core; ClinVar; the paid version of HGMD; Leiden Open Variation Database 2.0; and the Universal Mutation Database. According to the researchers, there was "substantial disparity of variant classifications among publicly accessible databases." 

Veritas' own database is compiled and curated from both public and private databases, Cifric said, and utilizes an algorithm "designed to increase the accuracy of genotype-phenotype correlation and lower incidence of variants of uncertain significance."    

He declined to comment specifically about Myriad's technology, but said, "We have, in my opinion, mounted the most comprehensive challenge to the Myriad database in terms of the [number] of patients that are represented by the database and the number of indications." Currently, Veritas' database has more than 8,000 mutations acquired from 500,000 patients, and in addition to the US launch of myBRCA, Veritas is preparing to launch the test in Europe and China, which would result in "large amounts of data … across ethnicities," he said. 

Veritas has also joined efforts such as FreeTheData and the Global Alliance for Genetics and Health and its BRCA Challenge to help build up the amount of publicly available and shared data on BRCA1/2 mutations. It also said it will continue contributing data to the National Institutes of Health-sponsored ClinVar database. 

In the meantime, while Cifric said that myBRCA is aimed at making it easier for more people to get BRCA1/2 testing, Rogers said that Myriad's tests remain widely accessible and patient out-of-pocket costs continue to be "very low." Though the company's tests lists for $4,000, on average 80 percent of patients who use Myriad's BRCA1/2 tests pay nothing out of pocket, while the average bill to patients is less than $100, Rogers said. He added that Myriad has several financial assistance programs for patients who cannot afford the company's tests, and last year, Myriad provided more than 4,000 free tests to uninsured patients. 

"At Myriad, we believe every patient should have access to the highest quality genetic testing because we know how useful it is in helping healthcare professionals deliver the best medical care," Rogers told GenomeWeb. 

But Erica Bartol, the founder of Promise to Feel 'Em and who was diagnosed with breast cancer at age 30, told GenomeWeb that too many people still don't have access to BRCA1/2 testing because they have been turned down by insurers who won't cover the tests. Those patients, she said, cannot afford to pay out of pocket. 

"So, I would be [interested in] surveying all major insurance companies to see how many [patients] were denied before even getting a chance to get tested or have been quoted a co-pay that they can't afford," she said. She added that even if 80 percent of Myriad's customers end up paying nothing themselves to get tested, there remains 20 percent who have to shoulder some cost. "Shouldn't everyone be able to afford it?"

And that, Cifric said, is Veritas' goal. "That's really the point of the test," he said, "to have an impact on the number of cases of breast cancer, to have a societal impact on reduction by giving people [access] to prevention." 

He noted that some studies suggest that the number of breast cancer diagnoses is anticipated to grow by 50 percent by 2030. 

The turnaround time for myBRCA, which is offered as a laboratory-developed test, is four weeks. Veritas has also implemented measures for accelerated turnaround times for emergency situations, Cifric said. 

The test is run out of the firm's CLIA-certified lab in Danvers, Massachusetts. Several states, including New York and Florida, have additional requirements in order for LDTs to be offered in their territories, and Veritas is in the process of obtaining such approvals. 

BRCA1/2 testing is also just the beginning of what Veritas plans to be a menu of tests targeting multiple cancers, as well as inherited diseases, according to Cifric, though he declined to provide details. 

In breast cancer, BRCA1/2 mutations account for just 15 percent of breast cancer cases, he said, and the company aims to develop tests to cover "all genetic aspects of breast cancer." Veritas anticipates launching other breast cancer-related products later this year.

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