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Diagnostics World | In a win for liquid biopsy, researchers from University of Texas MD Anderson Cancer Center have identified a protein that could spot pancreatic cancer in its early stages. The protein, which is shed from cancer cells, could serve as a target for early stage diagnostic tests for several hard-to-diagnose cancers.
Jul 27, 2015
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Diagnostics World Brief | MedGenome of Bengaluru, India announced a $20 million Series B investment from Sequoia Capital. The investment will support MedGenome in accelerating the expansion of its portfolio of genetic tests, enhancement of sequencing facilities in India and the US, and expanding its collaborative network with specialty hospitals, clinics, and genomic research institutions in India.
Jul 24, 2015
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FDA News | The U.S. Food and Drug Administration
has approved the Bio-Rad BioPlex 2200 HIV Ag-Ab assay, the first
FDA-approved diagnostic that differentiates between HIV-1
antibodies, HIV-2 antibodies, and HIV-1 p24 antigen in human serum
or plasma specimens.
Jul 24, 2015
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mobihealthnews | Theranos has been granted a CLIA
waiver for its herpes simplex 1 virus test. The move is the first
step for Theranos toward mobile health.
Jul 20, 2015
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Bio-IT World | After receiving FDA clearance for a single carrier screening test this
February, 23andMe has promised to release a new health product to its
customers later this year. But regulations are sure to change the types
of genetic tests available on the direct-to-consumer market — and lead
some to look for alternative ways to expand public access to useful
genomic information.
Jul 16, 2015
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Diagnostics World | Ancestry today announced the launch of AncestryHealth, a new entity and resource to empower consumers with important health insights to help promote wellness, prevent illness, and support healthier living. The company named Cathy A. Petti, MD, as AncestryHealth’s Chief Health Officer. At the same time, AncestryDNA announced that it has tested more than one million people with its $99 microarray tests.
Jul 16, 2015
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Diagnostics World Brief | Today, the U.S. Food and Drug Administration announced its approval of Iressa (gefitinib) for the first-line treatment of specific patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
Jul 13, 2015
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Forbes | A journalist walks into a lab, and less than 28 hours later has his bloodwork on his phone. Forbes contributor Dan Munro visited a Theranos lab inside a Phoenix Walgreens and takes the controversial clinical testing service for a ride
Jul 13, 2015
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Diagnostics World | Earlier this month, Selventa published in BMC Medical Genomics the results of a study showing that their tool—ClarifyRA—identified nearly a third of patients who didn’t respond to anti-TNF treatment. Identifying non-responders will let those patients move on to second or third line therapies without a costly and painful trial and error period. It's an important step forward for company's model of systems diagnostics.
Jul 13, 2015
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National Law Review | FDA plans to recognize "complementary diagnostics" as an additional category of tests to companion diagnostics.
Jul 10, 2015
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Diagnostics World Product Brief | Definiens has launched Tissue Studio 4.1, offering faster throughput for tissue image analysis, powerful machine learning, and the ability to automate routine image analysis tasks, enabling researchers to develop a customized image analysis solution in as little as twenty minutes, and reduce preclinical safety and toxicity study lengths from weeks to just days.
Jul 8, 2015
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Fortune | The FDA announced its approval of a Theranos test for the sexually transmitted disease herpes simplex virus (HSV-1) and--more importantly--approval for the Theranos platform.
Jul 2, 2015
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Xconomy | Natera's IPO is looming, with the offering coming as early as tonight. Xconomy reports that in documents filed today with the SEC, the company raised its fundraising goal to $175 million. The company hopes to sell 10 million shares at $17-$18 each.
Jul 1, 2015
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Diagnostics World Brief | In a new market report released this morning, BCC Research predicts the next-generation sequencing (NGS) clinical market could grow at a compound annual growth rate of 31.3% from $997.1m in 2015 to nearly $3.9b by 2020.
Jul 1, 2015
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Technology Review | Eventually, the most important use of liquid biopsies should be to catch signs of cancer early, before symptoms arise—when a surgeon can cure it by cutting it out. Such screening could profoundly reshape cancer medicine. For now, though, they are being used as “theragnostics”—that is, tests that guide decisions about treatment.
Jun 25, 2015
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Diagnostics World | Color Genomics is just one of several companies toying with a new model for selling low-priced DNA tests online, by enlisting physicians as intermediaries. If Color's business model becomes popular, it will have big implications for the way genomic testing reaches the broader public — and who sets the standards for this maturing technology.
Jun 22, 2015
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Diagnostics World Brief | Foundation Medicine has launched PatientMatch, a tool to connect doctors who are treating patients with similar rare genetic mutations. At Sarah Cannon Research Institute, physicians are finding it useful for connecting patients to the right drug trials as well.
Jun 22, 2015
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Diagnostics World Brief | The human body is host to an astonishing array of viruses, but efforts to study this secretive population have hit technological limitations. At Brigham & Women's Hospital in Boston, a new blood test is letting researchers look at patients' whole histories of viral infection, using their antibodies as a permanent record.
Jun 22, 2015