IVDT Insight

Redwood Toxicology Laboratory Announces Urine Test for Marijuana Mimics

Redwood Toxicology Laboratory Inc. (RTL) announced it now offers lab-based testing for the detection of JWH-018 and JWH-073 metabolites in urine. JWH-018 and JWH-073 are the primary synthetic cannabinoid receptor agonists responsible for the euphoric and psychoactive affects that imitate marijuana and are among the numerous compounds found in herbal incense or smoke blends. RTL laboratory analysis confirmed JWH-018 and JWH-073 as the active ingredients in 27 herbal mixtures, and established test methods to identify the presence of their metabolites.

RTL's test will utilize the most sophisticated, sensitive, and specific equipment and technology available, LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) to confirm JWH-018 and JWH-073 metabolites. This test methodology provides the most definitive synthetic cannabinoid biomarker test results.

The new RTL test panel is well suited for a variety of settings that have prevalent access to fake marijuana...

July 12th, 2010
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Cepheid Issues Recall of Xpert MRSA/SA BC Product

Cepheid initiated a recall of all lots of Xpert MRSA/SA BC (blood culture) product. The recall is a corrective action, which does not require return of product to the manufacturer. Customers may continue to use the product; however, when an MRSA negative/SA positive result is obtained, the result should be interpreted as "MRSA indeterminate/SA positive, antimicrobial susceptibility testing pending." Further testing should be performed using a FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle, as instructed in the Corrective Action Notice dated July 1, 2010. MRSA positive/SA positive results can still be reported as such. The new instructions will be incorporated in the product labeling. The Xpert MRSA/SA BC product produces false-negative MRSA results, which could potentially contribute to incorrect treatment of an MRSA infection.

Hospitals or laboratories that have purchased the Xpert...

July 2nd, 2010
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Roche, IBM Collaborate on Nanopore-Based DNA Sequencing Technology

Roche and IBM announced an agreement to develop a nanopore-based sequencer that will directly read and decode human DNA quickly and efficiently. Focused on advancing IBM’s recently published “DNA Transistor” technology, the collaboration will take advantage of IBM’s leadership in microelectronics, information technology and computational biology and Roche’s expertise in medical diagnostics and genome sequencing.

The novel technology, developed by IBM Research, offers true single molecule sequencing by decoding molecules of DNA as they are threaded through a nanometer-sized pore in a silicon chip. The approach holds the promise of significant advantages in cost, throughput, scalability, and speed compared to sequencing technologies currently available or in development.

Ultimately, the technology has the potential to improve throughput and reduce costs to achieve the vision of whole human genome sequencing at a cost of $100 to $1,000....

July 1st, 2010
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Samsung Ventures into IVD Market

According to the Korea Herald's Website, Samsung Electronics has made inroads into the IVD and medical device markets with the rollout of an ultra-fast blood-testing device.

The Korean electronics giant is looking to invest 12 trillion won ($9.85 billion) in the healthcare business by 2020 with the goal of achieving 10 trillion won in annual sales that year.

The new device, which checks levels of glucose, cholesterol and 17 other substances in the blood, is smaller and cheaper than conventional blood-testing equipment, and targets small- and medium-sized hospitals.

The company claims it takes only 12 minutes to conduct a blood test with the device, whereas it usually takes two to three days with traditional equipment.
 
Samsung will partner with Choongwae Pharma Corp., a Korean pharmaceutical manufacturer, to exclusively sell the device to hospitals nationwide.

Samsung has developed the medical equipment with a 30 billion won investment...

June 30th, 2010
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Industry Group Commends Supreme Court for Expansive View of Patentability

The Biotechnology Industry Organization (BIO) released the following statement in reaction to the Supreme Court’s decision to uphold the lower court’s ruling in Bilski v. Kappos:

“In our amicus brief, BIO urged the Supreme Court to overturn the lower court’s rigid new test for determining whether a method or process is eligible for patenting. We are pleased that the Justices crafted a narrow opinion that does just that. The Court was clearly conscious of the potential negative and unforeseeable consequences of a broad and sweeping decision,” stated BIO President and CEO Jim Greenwood.  “This ruling specifically states that the ‘machine-or-transformation test is not the sole test for patent eligibility’ and recognized that the lower court’s ruling could have created uncertainty in fields such as advanced diagnostic medicine techniques.

“In the Diamond v. Chakrabarty decision in 1980, the Supreme Court...

June 29th, 2010
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Eurogentec Signs Molecular Diagnostic Agreements With BD

Eurogentec SA announced finalization of two agreements with BD Diagnostics: a technology transfer and license agreement covering proprietary diagnostic manufacturing technology and a multi-year supply agreement.

Under the terms of the technology transfer and license agreement, Eurogentec will convey diagnostic manufacturing technology and provide technical assistance. BD expects to apply this technology to the production of commercial molecular diagnostic kits. Under terms of the supply agreement, Eurogentec will provide molecular diagnostic kit components to BD.

"Eurogentec is extremely pleased to partner with a leading global medical technology company such as BD," says Eurogentec CEO Jean-Pierre Delwart. “This is a powerful indicator of increased recognition for Eurogentec’s vision and technical expertise in IVD manufacturing by commercial developers of in vitro diagnostic products. The opening of our GMP/QSR compliant clean room...

June 28th, 2010
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Phadia Receives FDA Clearance for Autoimmune Assays

Phadia has received FDA 510K clearance for four new EliA autoimmune antibody assays. These new assays will provide physicians with additional tools needed to aid in the diagnosis of Antiphospholipid Syndrome (APS). The newly available EliA assays, anti-cardiolipin (aCL) IgG/IgM and anti-B2-glycoprotein 1 (anti-B2-GP1) IgG/IgM, have proven to be essential, sensitive, and specific markers to aid in the diagnosis of APS.

Gabi Gross, autoimmune franchise leader of Phadia US, says, “Since its inception in 1967, Phadia has set the standard in the detection and diagnosis of allergies. Now, with the introduction of the EliA autoimmune product line in the United States, we are providing laboratories and clinicians with the same standard providing diagnostic tools with high performance assays to support the diagnosis of autoimmune diseases such as antiphospholipid syndrome.”

The clearances extend Phadia’s product line of CLIA Moderately Complex assays in the...

June 25th, 2010
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Tethys Receives Patent Relating to Diabetes Risk Score Test

Tethys Bioscience Inc. announced that the United States Patent and Trademark Office has granted the company U.S. Patent 7,723,050. The patent is directed to the company’s groundbreaking PreDx Diabetes Risk Score (DRS) test and relates to proprietary methods for assessing the risk of developing a diabetic condition. Notably, this patent was issued following an accelerated review procedure which enables innovators to receive a final decision within 12 months of application. The issued patent is a milestone for Tethys and has potential applicability to other Tethys products in development.

PreDx DRS is a simple-to-use, multimarker blood test that enables accurate identification of patients who have the highest risk of developing type 2 diabetes within five years. PreDx DRS facilitates identification of the 10-20% of individuals at the highest, near-term risk, for whom lifestyle or other intervention may be most beneficial.

“The rapid issuance of this first...

June 24th, 2010
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New CDC Test to Detect 2009 H1N1 Influenza Virus Authorized for Use by FDA

A test developed by CDC to diagnose human infections with the 2009 H1N1 influenza virus (formerly known as swine flu or pandemic H1N1 flu) was authorized for use today by FDA.

The test, called the "CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel (IVD)," will help ensure the accuracy of influenza testing results among the different qualified laboratories that conduct influenza subtype testing in the United States and abroad. It uses a molecular biology technique to detect influenza A viruses and specifically the 2009 H1N1 virus. The new test will replace the previous real-time RT-PCR diagnostic test used during the 2009 H1N1 pandemic, called the "Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel)," which received an emergency use authorization by FDA in April 2009.

The earlier test was developed based on the limited number of 2009 H1N1 specimens available at the start of the 2009 H1N1 pandemic in April 2009. The...

June 23rd, 2010
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FDA Approves Abbott's HIV Test

Every nine and a half minutes, someone in the United States is infected with HIV, and one out of every five of these individuals doesn't know it. To help stem the spread of this disease, FDA approved an innovative new diagnostic tool, which will allow patients to be diagnosed earlier than ever before.

Abbott's Architect HIV Ag/Ab Combo assay is the first test approved in the United States that can simultaneously detect both HIV antigen and antibodies. HIV antigen is a protein produced by the virus immediately after infection, whereas antibodies are developed days later as the body works to fight off the infection. Studies have demonstrated that Abbott’s new test may detect HIV days earlier than antibody-only tests, which is important in controlling the spread of the virus.

Studies conducted by CDC show that current antibody-only tests miss up to 10 percent of HIV infections in some high-risk populations because they do not detect antigens. However, Abbott’...

June 22nd, 2010
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