Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Foundation Medicine got a patent for its cancer genomic sequencing technology, and now it's using that patent to sue one of its rivals in the liquid biopsy market. Becton Dickinson scored European approval for its test for vaginal bacterial infections. Last but certainly not least, 10x Genomics released a new system for long-range genomic profiling. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
Foundation Medicine wages patent war against Guardant Health over liquid biopsy tech
Earlier this week, Foundation Medicine ($FMI) revealed that it got a patent for its cancer genomic sequencing technology. The company is planning to "evaluate strategies to maximize the value of this patent" and other intellectual property, CEO Michael Pellini said in a statement.
One of those strategies is suing its competitor, Guardant Health. Foundation in a suit filed earlier this week with the Easter District Court of Texas claims that Guardant's liquid biopsy test infringes on its patent. Foundation's patent runs until 2032 and makes "fundamental claims describing methods of analyzing a cancer patient's tissue or blood specimen to detect multiple classes of genomic alterations," the company said in a statement.
Unsurprisingly, Guardant doesn't see things in the same light. "Since its inception, Guardant Health has more than 50 patents and patent applications in this area," the company said in a statement seen by Business Insider. "We are and will continue to be committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology. We believe this lawsuit is without merit and we will vigorously defend our position."
Foundation doesn't want the legal battle to get ugly, though. The Cambridge, MA-based company does "not intend to block the use of methods covered by the patent in patient testing that may be offered by others," Pellini said. How the patent war will play out is anyone's best guess. Statement | Story
Becton Dickinson gets European nod for vaginal infection test
Testing giant Becton Dickinson ($BDX) chalked up some success overseas this week after European regulators signed off on its in vitro diagnostic tests for vaginal bacterial infections.
The test screens for bacterial vaginosis (BV), candidiasis (CA) and trichomoniasis (TV), the most common infectious causes of vaginitis, through real-time PCR extraction and amplification. The diagnostic responds to a prevalent women's health issue.
Up to 75% of women have at least one case of vaginitis (CA, TV) or vaginosis (BV) in their lifetime, according to data cited by the company. And co-infections and recurring infections are common, which can translate into increased costs for patients and providers.
BD's test represents "an important advancement because using traditional methods to detect the responsible microorganisms can be challenging, due to the presence of many interfering substances in specimens, the large number of mixed infections which occur and the subjectivity of these methods, which can lead to inconsistent interpretation of test results," Patrick Murray, BD's senior director of scientific affairs, said in a statement. The company's tests "has the potential to help clinicians improve patient management and help laboratories increase workflow efficiency," Murray said. Release
10x Genomics rolls out new sequencing system with eye on global market
10x Genomics has been growing by leaps and bounds. Bolstered by its recent success, the company is launching a new sequencing system for long-range genomic sequencing in the global market.
Pleasanton, CA-based 10x Genomics' Chromium system "will be invaluable for a broad range of researchers and clinicians who want to capture the most value from their experiments and appreciate seamless integration of the technology into their current workflows," CEO Serge Saxonov said in a statement. The technology includes a solution for deep profiling of complex cell populations and another solution that can look at longer regions missed with short-read sequencing.
10x Genomics plans to present scientific data for the system at the upcoming European Society of Human Genetics Conference in Barcelona, Spain. Statement