Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza
Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.
In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”
The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice. Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.
According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.
Supreme Court Invalidates Claims to Naturally Occurring DNA
On June 13, 2013, the Supreme Court issued a unanimous decision finding that claims to naturally occurring DNA segments were invalid under the Patent Act because DNA is a product of nature and therefore not patent eligible. Myriad, the patentee, discovered the precise location and genetic sequence of the BRCA1 and BRCA2 genes, but did not create or alter the genetic information encoded in the BRCA1 and BRCA2 genes.
The Court also ruled that a second set of claims to complementary DNA (cDNA) sequences are patent eligible because cDNA is not naturally occurring. As a result, cDNA therefore does not present the same obstacle to patentability as naturally occurring, isolated DNA segments.
The Court expressed no opinion regarding method claims, new applications of knowledge about the BRCA1 and BRCA2 genes, or patentability of DNA in which the order of naturally occurring nucleotides has been altered, noting they are not implicated by this decision. A copy of the Supreme Court’s opinion is available here: Assoc. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398.
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