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ILLUMINA AND THE FUTURE OF LIFE SCIENCES

  Wednesday, July 24, 2013

The moment some investors learned that ILLUMINA (ILMN) might acquire Advanced Liquid Logic (ALL), they debated selling the stock without knowing anything about the acquired firm or the advantages Illumina will add to its technological capability by acquiring it. Is this not the rule of thumb made possible by the power of computers’ programing? ILMN was already down anyway for the day, losing $0.95 during the bad NASDAQ day for the biotech sector in general. Long-term serious investors who are lured to sell ILMN must have felt bad when they heard the news after the end of Monday trading day.     More...

Illumina, Roche and Fairness

  Thursday, February 09, 2012

Illumina (ILMN) is occupying the center stage these days. Roche’s persistent attempts to acquire ILMN, has opened investors’ eyes on the importance of this firm’s technology in moving away from the road of stagnation to that of innovation. Innovation is the insurance that guarantees the survival and growth of the drug companies in the future that has already begun. Illumina’s technologies and marketed state-of-the-art sequencers and gene analyzers have been a major contributor to the flourishing of information about the origins of diseases at the molecular level.  This capability, which lured Roche, was overlooked by Wall Street investors who have recently caused a selloff in the stock for theorized reasons. The real value of Illumina resides in its indispensability as the cornerstone of future advancement in medical diagnosis and treatment. With all the new-targeted drugs on the market and in the firms’ pipelines, the current diagnostic and treatment statuses are still far from perfect. More...

A New State-Of-The-Art Diagnostic Test

  Wednesday, July 14, 2010
The Biotechnology Revolution: A New State-Of-The-Art Diagnostic Test



Genomics are changing the way medicine is being practiced, bringing to the labs state-of-the-art diagnostic tests that do much more than ruling in, or out diseases. The new laboratory tests enable physicians to determine the most effective treatment options for their patients’ diseases, to monitor the disease progression and install the treatment at the right time.  This is no dream any longer, but reality. The latest news about achievements in this domain comes from Life Technologies (LIFE) and Asuragen, which announced yesterday they have achieved CE-marking and commercial launch in Europe of the BCR/ABL1 Quant™ Test that  enables clinicians to monitor and treat patients afflicted with chronic myeloid leukemia (CML).



Asuragen's clinically validated and cGMP manufactured the BCR/ABL1 Quant™ Test, which is  distributed by Life Technologies (LIFE) and runs on its Applied Biosystems’ CE-marked 7500 Fast Dx Real-Time PCR Instrument™. The test for leukemia progression is a quantitative in vitro diagnostic test. It helps doctors determine the most effective treatment options for CML. The test monitors the BCR-ABL1 to ABL1 ratio by reverse transcription quantitative polymerase chain reaction (RT-qPCR) on whole blood or bone marrow of diagnosed Philadelphia chromosome positive chronic myeloid leukemia (CML) patients expressing b2a2, b3a2 or e1a2 fusion transcripts. The test is intended as an aid in the assessment of complete cytogenetic response (CCyR), major molecular response (MMR), minimal residual disease and relapse in CML patients. 



The BCR-ABL1 fusion gene arises from a specific chromosome translocation, known as the Philadelphia chromosome or t (9:22). The resulting BCR/ABL1 fusion transcripts are present in approximately 95% of CML. If present, the expression level of the fusion transcript or its ratio to a reference transcript may be used to monitor disease progress. Monitoring the level of BCR/ABL1 may be helpful for both prognosis and management of Gleevec®, Tasigna®, Sutent® and Sprycell® kinase therapies in patients with leukemia disease.

To read the press release and about the firms go to: 

http://www.lifetechnologies.com/news-gallery/press-releases/2010/asurage-ad-life-techologies-lauch-ce-marked-bcr.html    

Asuragen and Life Technologies have plans to pursue future regulatory clearance for a BCR/ABL1 Quant test in the United States. 



See Also: Illumina (ILMN), Sequenom (SQNM), Clinical Data (CLDA), Compugen (CGEN) More...

The fruits of the Human Genome Project Are Ripening

  Friday, June 04, 2010
In June 2009, Illumina announced the launch of its individual genome sequencing service. The service is built around physician-patient consultation, with a physician’s order required to initiate the process. Sequencing is performed in Illumina’s CLIA-certified, CAP-accredited laboratory, following a rigorous process that focuses on physician involvement, patient privacy and data quality. The news was big, but what makes such milestones in the medical fields achievable is individuals’ serious consideration, which is possible only through offering them explanation of the purpose of the newly suggested process. In the case of individual genome sequencing (IGS), individuals should know more about sequencing, its purpose, the results and the impact on their protection and treatment, in case they are diagnosed with a sickness. The June 2009 announcement of the sequencing service, Illumina was not crystal clear on both the clinical utility of the sequencing and its cost.    

Today, Illumina (ILMN) announced the price of IGS. The details of the clinical utility of the sequencing is mostly left for physicians to elaborte on, as they are the decision makers with regard to IGS. The price decided upon is $19,500 for individual genome sequencing service and $14,500 per genome for groups of five or more participants using the same physician. In other words, to help lower the cost for clients, a physician can order five genome sequencing at a time thus saving $5000 for each individual. This is not all. Patients who suffer from serious medical conditions for whom IGS could provide potential direct clinical value the cost will be $9,500 per genome. In all cases, the service requires individuals to follow Illumina’s physician-mediated process, which involves pre-service consultation, consent, and a seven-day cooling off period, with final genome data returned to the physician.

There is no doubt that the announced price of IGS service, especially for disease-threatened patients helps opening the door to a new era where the diagnostic procedures will not only diagnose the pathology, but also its origin, i.e., the root-cause of the disease. Also, the new cost, $9,500, will definitely be a factor in making things happen. This price is much lower than the $25,000 suggested in the past. This step will open the door to therapeutics and therapeutic procedures through emerging technologies such as gene editing through antisense, RNA interference (RNAi, microRNAi and gene switching). Serious biotech companies specialized in these disciplines include ISIS (ISIS), which uses its antisense products for gene-editing, in addition to its microRNA technology developed through a Regulus Therapeutics, a company it established through a joint venture with Alnylam (ALNY), which is also specialized in RNA interference technology. Other firms include, RXI Pharmaceuticals (RXII), which is also specialized in the same. 

We expect the price of individual genome sequencing (IGS) will further drop through more technological advancements, which have been a major factor in driving the cost down in the first place. The lowering of the price will definitely lead to increasing the number of individual genome sequences, which will be compared them to those of the public databases being populated by academia. The content of the databases will be enriched and the entire field accelerated. That’s what Illumina believes would be the case. Moreover, Illumina intends to create the World Genome Registry, a web-based resource for those who have been sequenced to record the date they were sequenced, at what coverage and with which technology platform. This web site will keep the consumer genetics community updated on the current global numbers and status of whole-genome human sequences being generated. The company intends to create this resource and then turn it over to the community once it is established.

Illumina’s (IGS) service provides valuable information regarding individual genetic makeup. Although curiosity could be a driven motive for some people to ask for sequencing their genomes, a good motive should be health-driven such as existing illnesses or family history of diseases. Once the sequencing has been completed, geneticist physicians and the patients’ physicians will review the results and help the individual formulate an action plan, which may include ordering more clinically tests to further investigate the health concerns. Once found vulnerable to developing a disease, or sick, patients will have the chance to receive a much better protective and preventive measures, or, in case of sicknesses, the treatments that work for them, not against their genetic constructs. That’s why we reiterate that the biotech firms specialized in genomics are the heart of the biotechnology industry. We expect more from the genomics group and we definitely expect much more from Illumina. 

Disclosure: No position. More...

ILLUMINA (ILMN): Today’s News Is What We Want To Hear

  Thursday, April 08, 2010

Those who follow on the advancement of biotechnology achievements walk up every day looking for specific news about breakthrough treatments for cancer and chronic devastating diseases, not for just a modest improvement of drugs, or me-too drugs that do little against the diseases and a lot in devastating the healthcare budget. The more we see breakthroughs, the more we get greedy, asking or at least hoping for more treatments that work at the root-cause of diseases, personalized medicine, where patients are protected from treatments that promise better disease management, but are themselves etiologies of new diseases, adding different pathologies and devastation than the diseases they are supposed to treat.

We don’t want today’s news coming from Illumina to be missed by those who are interested in the advancement of molecular biology, computer science and biotechnology in general. We want to bring this news to the patients who suffer the adverse events of their treatments in addition to the devastation of their diseases. We want to bring it to the researchers in pharmaceutical and biotechnology companies who dream about cutting the enormous expenses of clinical trials and shortening the time required to take their molecules from the preclinical laboratory to the market.

In a press release Illumina (ILMN) announced the launch of its VeraCode ADME Core Panel designed to help researchers study genetic predispositions for differential drug response and adverse events. The Panel offers the most complete representation of the key biomarkers associated with drug absorption, distribution, metabolism and excretion (ADME) as standardized by pharmaceutical industry experts in the PharmADME Core List. Researchers using the product can analyze key ADME content in as little as one day, which never happened before.

Dan Masys, M.D., chair of Bioinformatics at Vanderbilt University said, “We selected the ADME Core Panel for its multiplex coverage of the key biomarkers associated with drugs in our initial study, and for its efficiency in processing samples. We are looking for a set of variants that reliably predict an adverse effect from a medication, and have over 80,000 DNA samples with matched, de-identified medical records to support the study.” Dr. Masys is leading the Vanderbilt Electronic Systems for Pharmacogenetic Assessment study using the VeraCode ADME Core Panel to generate an extensive pharmacogenetic database. This database will be widely used to link genotypes to drug response phenotypes extracted from electronic health record data.

What does the VeraCode ADME Core Panel offers? According to the firm’s press release, it offers the following:

The VeraCode ADME Core Panel contains 184 biomarkers in 34 genes, with the highest coverage of the PharmADME Core List. This list, produced by the PharmADME Working Group of industry and academic experts, provides comprehensive coverage of the most biologically relevant biomarkers spanning complex regions of the genome.

Rapid and precise genotyping assay: Using a highly specific and streamlined chemistry, DNA can be genotyped within 8 hours with less than 2.5 hours of hands-on time, enabling researchers to complete studies faster than ever before.

Data precision with an excellent call rate. The supporting software for VeraScan offers a convenient user interface that manages user authentication, logs system activity, and automatically translates genotype data into the star nomenclature used by researchers to analyze pharmacogenetic data.

“Understanding genetic variability associated with drug response and disposition is a key step toward the realization of personalized medicine, and the VeraCode ADME Core Panel will help enable this exciting transformation,” said Jay Flatley, president and CEO of Illumina. “With the cost of bringing a new medicine to market now exceeding $1 billion and over $220 billion spent annually on medications in the U.S., it is critical that we look for savings in all stages of drug development. With its emphasis on rapid operation and high-quality data, the VeraCode ADME Core Panel can help bring safe and effective therapies to patients as quickly as possible.“

That is what we precisely expect from the biogenetic revolution. Far-reaching, but safe drugs, personalized medicine, using computers, instead of torturing animals and bringing down the healthcare cost. You know what? If we don’t bring down the cost of developing new drugs, we will end up not able to use them at the time they reach the market, let alone developing them.

Thank you ILLUMINA.

For more information visit www.illumina.com/VeraCodeADME.

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