Sequenom suffers setback in court over cell-free fetal DNA patent; Biocept links up with Baylor for breast cancer liquid biopsy tests

Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Sequenom suffered a setback in its ongoing courtoom saga regarding the company's patent for circulating, cell-free fetal DNA. Biocept revealed that it would team up with Baylor College of Medicine to create minimally invasive blood-based tests that can detect estrogen gene mutations in breast cancer patients. Last but certainly not least, OPKO Health's GeneDx unit is trumpeting results from a study showing that whole genome sequencing can identify patients with rare, complex genetic conditions. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)

Sequenom loses a round in courtroom battle over cell-free fetal DNA patent

Sequenom ($SQNM) had a tough go of it in court this week, with the U.S. Court of Appeals for the Federal Circuit denying the company's request to reconsider an earlier ruling against its '540 patent for cell-free fetal DNA (cffDNA). The court's decision didn't exactly come as a surprise, Sequenom said in a statement, as a panel of three judges over the summer upheld a lower court's decision that found that company's patent for cffDNA was invalid.

And the latest ruling "has little business impact" on Sequenom, the company said in a statement. Last December, Sequenom settled the score with Illumina ($ILMN) in another patent battle, with the two companies agreeing to pool their resources to develop noninvasive prenatal tests (NIPT). Plus, Sequenom already has similar patents for cffDNA that are valid in Europe, Japan, Hong Kong, Canada and Australia.

But the battle isn't over yet. The San Diego, CA-based company is considering appealing its case to the Supreme Court of the United States, Sequenom said in a statement, which would settle the score once and for all about its patent's validity. Statement | More

Biocept joins up with Baylor for liquid biopsy collaboration

Hot on the trail of liquid biopsy deals, Biocept ($BIOC) is teaming up with Baylor College of Medicine to create minimally invasive blood-based tests that can pinpoint mutations in the estrogen receptor gene (ESR1) to see whether women with breast cancer are resistant to certain therapies. The pair will use Biocept's circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) molecular diagnostic platforms to screen for the mutations, potentially giving doctors a better idea of how to treat a patient's specific cancer.

Tests developed through the collaboration could offer an advantage over traditional surgical tumor biopsies, which are more invasive and sometimes not possible due to a patient's health, the company said in a statement.

"Reducing the number of invasive and expensive surgical biopsy procedures for patients with breast cancer is a core focus at Biocept. Our blood-based approach could also overcome the limitation of tumor heterogeneity associated with tissue biopsies through the ability to capture a more complete look at the tumor's overall makeup," Biocept CEO Michael Nall said in a statement. Release

OPKO trumpets positive results from whole exome sequencing study for rare genetic disorders

It's been a busy year for OPKO Health ($OPK). In June, the Miami, FL-based company shelled out $1.47 billion for Bio-Reference Laboratories, inheriting GeneDx, Bio-Reference's genetic sequencing lab, as part of the deal. Now OPKO is moving forward with GeneDx's sequencing tech, revealing promising data from a new study that shows that whole exome sequencing can help diagnose patients with rare and complex genetic conditions.

GeneDx scoured 3,040 whole exome sequencing cases over three years to see how the technology could flag signs and symptoms of certain disorders in patients. The company found that when genetic data from the patient's parents or affected family members was included in the analysis, it became easier to diagnose the person's condition. The findings "underscore the benefit of testing parents and the patient" and show that whole exome sequencing can identify potentially harmful variants in genes "which would have otherwise been missed," Bio-Reference Laboratories CEO Marc Grodman said in a statement. Statement

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