Tue, Mar. 22, 8:46 AM
- Sequenom (NASDAQ:SQNM) has petitioned the U.S. Supreme Court to review lower court decisions. that the claims of its U.S. Patent No. 6,258,540 ('540 patent) are not patent eligible. In October, 2013, a U.S. District Court ruled that the patent, covering the detection of cell-free DNA in the blood of pregnant women, was invalid because a phenomenon of nature is unpatentable. The ruling was upheld on appeal.
- CEO Dirk van den Boom, Ph.D., says, "We continue to believe that the groundbreaking techniques embodied in the '540 patent are eligible for patent protection. More broadly, we believe our case provides a compelling opportunity for the Supreme Court to clarify patent eligibility criteria to protect the significant investments made by Sequenom and other life sciences organizations that have undoubtedly advanced the standard of patient care and treatment, as well as encouraging future such investments."
- The company says the lower court decision will not have a material impact on its ongoing business since it has been operating under the District Court's invalidity ruling since October 2013 and it has a pooling arrangement of NIPT (noninvasive prenatal testing) intellectual property with Illumina (NASDAQ:ILMN).
- Previously: Ilumina and Sequenom settle patent infringement claims (Dec. 3, 2014)
- Update: On June 27, the company announced that the U.S. Supreme Court denied its petition to review the lower court's decision.
Wed, Mar. 9, 8:20 AM
- Thinly traded nano cap Biocept (NASDAQ:BIOC) closes a contract with preferred provider organization (PPO) FedMed for access to its Target Selector liquid biopsy testing.
- FedMed, founded in 2000, provides medical services access to over 40M Americans through its PPO of more than 550K doctors, 4K hospitals and 60K ancillary care providers.
- Biocept's testing detects circulating tumor DNA (ctDNA) in a peripheral blood sample obtained via a routine blood draw. Tumors consistently shed bits of DNA that circulate in the blood which has potential for detecting and monitoring cancer. Because the amounts of ctDNA are very small, the clinical utility wasn't there until high powered sequencers became available, such as those made by Illumina (NASDAQ:ILMN). The value proposition of liquid biopsy is lower cost, greater convenience and much more patient-friendly that traditional tissue biopsy.
- Shares are up 13% premarket on light volume.
- Liquid biopsy-related tickers: (NASDAQ:TROV)(NASDAQ:TBIO)(NASDAQ:SQNM)(NASDAQ:CDNA)
- Previously: Biocept's liquid biopsy matches 93% of lung cancer tissue biopsies in study (Feb. 26)
Mon, Mar. 7, 4:17 PM
Wed, Mar. 2, 11:19 AM
- Birmingham, AL-based Circulogene Theranostics announces that it has received its first international orders for its liquid biopsy tests that only require a single drop of blood. The company's tests, launched less than three months ago, detect cell-free DNA (cfDNA) associated with 10 tumor types, including breast, lung and colon cancer.
- According to the privately held company, its proprietary method enables it to collect 100 times more cfDNA compared to the industry standard with 1/10 the sample size (~20 microliters) because it avoids the loss of cfDNA that typically occurs in the extraction and isolation steps.
- Its liquid biopsy testing can detect almost 3,000 cancer mutations on 50 well-established cancer-related genes in its 10 cancer profiles.
- Related tickers: (TROV +1.6%)(TBIO -1.3%)(SQNM)(BIOC -1.4%)(CDNA -1.2%)(ILMN -0.6%)
Fri, Feb. 26, 11:02 AM
- Results from a recent study show Biocept's (BIOC +2%) liquid biopsy test that detects bits of tumor-related DNA in the blood agreed with tissue biopsy results 93% of the time in 74 lung cancer patients. The data were presented in a poster session at the UCSD Moores Cancer Center Industry/Academia Translational Oncology Symposium in San Diego, CA.
- Biocept's test detects circulating tumor DNA (ctDNA) in a peripheral blood sample obtained via a routine blood draw. Tumors consistently shed bits of DNA that circulate in the blood which has potential for detecting and monitoring cancer. Because the amounts of ctDNA are very small, the clinical utility wasn't there until high powered sequencers became available, such as those made by Illumina (ILMN +1.4%). The value proposition of liquid biopsy is lower cost, greater convenience and much more patient-friendly that traditional tissue biopsy.
- Related tickers: (TROV -4.5%)(TBIO +6.6%)(SQNM -2.1%)(CDNA +2.8%)
Wed, Feb. 17, 7:08 AM
- Researchers at Cal State say they have developed a liquid biopsy test for the detection of prostate cancer that is based on a single drop of saliva. They claim that it can be performed in 10 minutes and is 100% accurate.
- Professor of oncology David Wong and prostate cancer surgeon and urologic oncologist Dr. David Samadi expect to start clinical trials by the end of this year. If successful, they say FDA clearance could happen within the next two years.
- A tumor sheds tiny amounts of DNA that the medical community has discovered circulate in the blood and can be found in other body fluids such as urine and, apparently, saliva. This cell-free DNA (cfDNA) or circulating tumor DNA (ctDNA) can be detected and analyzed using state-of-art sequencers such as those made by Illumina (NASDAQ:ILMN). This is called "liquid biopsy" because of the sample source. A traditional biopsy is performed on a tissue sample.
- Proponents of the liquid biopsy concept say it represents a paradigm shift in the detection and management of cancer since it has the potential for low-cost, non-invasive cancer screening and monitoring.
- Related tickers: (NASDAQ:TROV)(NASDAQ:TBIO)(NASDAQ:SQNM)(NASDAQ:BIOC)(NASDAQ:CDNA)
Wed, Feb. 10, 11:35 AM
- Illumina (ILMN +2.4%) taps board member and former Google executive Jeff Huber to lead Grail, its startup company that is developing a test to detect cancers at their earliest stages.
- Mr. Huber's 12-year Google career involved working on advertising products, Google Maps, Google Earth and the life sciences arm of Google X.
- Grail was started in January with more than $100M in funding from the likes of tech titans Bill Gates and Jeff Bezos. Its aim is to develop a "pan-cancer" screening test that can detect very minute levels of tumor-associated material in the blood called cell-free DNA. The process is called a liquid biopsy in light of its similar diagnostic objective to a tissue biopsy, that is, to detect very early-stage cancer. It will use Illumina's latest sequencing technology to analyze the samples. It expects to initiate a large clinical trial in 2017.
- Illumina invested $40M in Grail's first funding round and owns more than 50% of the company.
- Related tickers: (TROV -1.3%)(TBIO +5.4%)(SQNM +6.5%)(BIOC -0.7%)(CDNA -2.5%)
Tue, Feb. 2, 4:43 PM
- Illumina's (NASDAQ:ILMN) Q4 gross margins were 69.4% vs. 75.1% Y/Y. Non-GAAP gross margin was 71.7% compared to 72.3% in the prior year period.
- Management: “We closed 2015 with strong momentum as fourth quarter orders and revenue exceeded our expectations. Our recent product announcements of MiniSeq™ and Infinium® XT further enhance the most extensive genomics portfolio available. This portfolio, combined with our investments in Project Firefly, Helix, and GRAIL, will position us for long-term growth as we enable our continued penetration of the enormous markets ahead.”
- Conference call begins at 5:00 PM ET. We have the webcast here.
- Shares flat AH.
- Related: Illumina: A Recently-Confirmed, But Undisclosed SEC Investigation (Dec. 4)
Tue, Feb. 2, 4:36 PM
- Illumina (NASDAQ:ILMN): Q4 EPS of $0.81 misses by $0.01.
- Revenue of $592M (+15.5% Y/Y) beats by $6.82M.
Tue, Feb. 2, 6:45 AM| Tue, Feb. 2, 6:45 AM | 1 Comment
Mon, Feb. 1, 5:35 PM
Mon, Jan. 11, 4:00 PM
- Bio-Rad (BIO -0.1%) and Illumina (ILMN +0.3%) enter into an exclusive partnership to develop the most comprehensive next-generation sequencing (NGS) workflow for single-cell analysis. The end-to-end commercial system will enable high throughput sequencing of thousands of individual cells, historically a time-consuming, costly and laborious process.
- Single-cell gene expression data provide much better cell function, disease progression and therapeutic response information than studies performed on bulk tissue samples with which gene expression data are averaged across cells due to the presence of multiple cell types with different functions. In neurological tissues, for example, there are hundreds of specialized cell types so being able to isolate them for genetic analysis would be of profound interest to drug developers as well as researchers.
- The companies expect to launch the system no later than early 2017.
Fri, Jan. 8, 5:50 PM
- Illumina (NASDAQ:ILMN) saw a lot of action from analysts this week. Deutsche Bank initiated coverage with a Hold rating and $192 (16% upside) price target. Avondale Partners initiated with a Market Perform rating and $175 (6% upside) price target. Wells Fargo downgraded it to Market Perform from Outperform with a $170 - 180 price target. Cowen and Company reiterated its Outperform rating and raised its price target to $215 (30% upside). Barclays maintained its Equal Weight rating and raised its price target to $170 - 175.
- TetraLogic Pharmaceuticals (NASDAQ:TLOG) initiated with Buy rating and $5 (1,463% upside) price target by Roth Capital.
Fri, Jan. 8, 4:26 PM
Dec. 14, 2015, 12:37 PM
- Beijing-based Novogene and Ilumina (ILMN +0.1%) enter into a collaboration agreement to jointly develop a user-friendly diagnostic system based on next-generation sequencing (NGS) technology for clinical prenatal DNA and oncology testing in the Chinese market.
- Ilumina will leverage its expertise in sequencing systems and Novogene will leverage its advanced clinical application development capabilities. Specifically, Novogene will provide its nucleic acid extraction, library preparation and data analysis software while Ilumina will provide NGS instrumentation components and related reagents.
- Financial terms of the partnership are undisclosed.
Nov. 12, 2015, 5:47 PM
- Illumina (NASDAQ:ILMN) will replace Sigma-Aldrich (set to be acquired by Merck) in the S&P 500 following the Nov. 18 close.
- Shares have risen to $162.00 after hours.