molecular diagnostics
Study: TP PCR Streamlines Testing for Huntington's Disease
A new test may help to streamline genetic testing for Huntington's Disease by generating accurate results, avoiding unnecessary additional testing, and improving turnaround time. The test, which uses chimeric or triplet-repeat-primed PCR (TP PCR) methodology, yielded results that were 100% concordant with standard genotyping methods in an analysis of 246 samples. The high sensitivity and specificity of the test could reduce the number of false negative results and facilitate both...
Hologic Sells Transfusion Assay Business to Immucor
Looking to sharpen its diagnostic business focus, Hologic has sold a business unit it acquired when it bought Gen-Probe in August 2012. Immucor, a manufacturer of reagent instruments for blood transfusions, has agreed to purchase the outstanding shares of Lifecodes from Hologic for $85 million in cash. The transaction includes a contingency payment of $10 million based on financial targets in the 2013 calendar year. Lifecodes sells molecular and antibody-based assays for transplant diagnostics...
Exact Sciences CEO Shares Business Insights at Irish CEO Forum
While I was in Galway, Ireland, last week to attend the Irish Medical Technology Industry Excellence Awards, I had the opportunity to speak with Kevin Conroy, President and CEO of Exact Sciences (Madison, WI). His company has developed a stool DNA colorectal cancer screening test, the first module of which was submitted to FDA for premarket approval on December 7, 2012. Conroy was invited to address the CEO Forum, an all-day meeting on December 13 held prior to the gala dinner and...
Qiagen Earns SFDA Approval To Market CareHPVl Test in China
Qiagen N.V. announced that China’s State Food and Drug Administration (SFDA) has approved the company's careHPV Test and instrument platform. The test is the first molecular diagnostic to screen for high-risk human papillomavirus (HPV) designed for low-resource clinical settings, such as areas lacking electricity, water, or modern laboratory infrastructure. Qiagen expects to announce the availability of careHPV in China in January 2013, followed by India later in 2013 and other emerging...
BioView To Develop Digital Imaging Software for Abbott's Automated Vysis ALK FISH Probe Test
Abbott and BioView Ltd. have entered into an agreement in which BioView will develop automated digital imaging software for use with Abbott's molecular diagnostic test to detect rearrangements of the ALK gene in patients with advanced non-small cell lung cancer (NSCLC). The imaging software scans lung tissue specimens that have been tested for the ALK gene rearrangement with Abbott's fluorescence in situ hybridization (FISH) technology.   BioView is engaged in clinical trials that will...
Trivitron Buys Finnish Dx Company for $20M
Trivitron Healthcare Private Ltd. of Chennai, India, has purchased a Finnish diagnostics company for approximately $20 million. The acquisition of Ani Labsystems will give Trivitron entrée to the POC testing, immunodiagnostics, and molecular diagnostics market, the company says. In addition to Ani Labsystems, the Finnish firm comprises Ani Biotech, Biopoint, and K3. Trivitron plans to merge the businesses into a company called Labsystems Diagnostics Oy. Ani Labsystems makes diagnostic...
PerkinElmer Acquires Chinese Nucleic Acid-Based Screening Company
PerkinElmer says it has completed its acquisition of Haoyuan Biotech Co., Ltd. for approximately $38 million in cash and future revenue-based considerations. Shanghai-based Haoyuan manufactures molecular infectious disease screening tests for blood banks and clinics. The acquisition gives PerkinElmer an additional four infectious disease assays approved by China’s State Food and Drug Administration. One of the diagnostics is a qualitative 3-in-1 assay for detecting hepatitis B (HBV),...
Multiplexed MDx Chip from Veredus Detects TB In Less Than Three Hours
Veredus Laboratories, a supplier of molecular diagnostic tools, has launched VereMTB, a multiplexed molecular diagnostic chip capable of fast and accurate detection of mycobacterium tuberculosis complex (MTBC) and its mutations, as well as nine other clinically relevant non-tubercular mycobacterium. These mutations are responsible for resistance to multiple drugs and are reinvigorating the global spread of tuberculosis.   Conventional methods of accurately identifying TB infections can...
Exonhit and InGen BioSciences Merge to Create Diaxonhit
Say “bonjour” to Diaxonhit. That’s the name of the new French IVD company that will debut with the upcoming merger of Exonhit and InGen BioSciences S.A. The Paris-based personalized medicine company announced November 6 that it has signed an agreement to purchase InGen for €18 million. Eight million euro of the purchase price will be in cash and the remainder will be in Exonhit stock issued to InGen shareholders. Pending the approval of Exonhit’s shareholders, the...
BD Diagnostics, Lab 21 to Develop Oncology Assays for BD Benchtop System
BD Diagnostics and Lab 21 will collaborate on the development of oncology assays for the BD MAX benchtop molecular system, the companies announced. Lab 21 will develop PCR-based assays on the BD MAX platform, and BD will manufacture and sell the tests worldwide. Focusing on cancer patients, the companies plan to design the first two assays to detect mutations in the KRAS and BRAF genes. The assay will be the first personalized cancer diagnostics test designed for the BD MAX system. The...