News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Human Longevity Inc. Unleashes Power of Whole-Genome Sequencing to Unlock Keys to Healthy Aging; Research May Lead to New Clinical Laboratory Tests

Human genome pioneer J. Craig Venter’s newest project seeks to ‘change the way medicine is practiced’ by creating genomic-based medicine model

With little fanfare or public notice, a start-up company in San Diego is busy sequencing the largest number of whole human genome sequences in the world. The knowledge expected to result from this effort promises to revolutionize healthcare, as well as clinical laboratory testing.

Human Longevity Inc. (HLI) is a genomics and cell therapy company that has assembled the largest human genome sequencing operation in the world. It’s goal is to use whole genome sequencing and cell-based therapeutics to redefine aging and “meaningfully extend the human lifespan.”

“HLI’s mission is to identify the therapeutically targetable mechanisms responsible for age-related human biological decline, and to apply this intelligence to develop innovative solutions to interrupt or block these processes, meaningfully extending the human lifespan,” HLI states on its website. “We are trying to tackle some of the most vexing diseases like cancer, heart disease, and diabetes … we are working to change the way medicine is practiced through our genomic-focused, preventive model.” (more…)

J. Craig Venter Joins Race to Crack the Puzzle of Human Aging with New Company That Aims to Sequence 100,000 Human Genomes Yearly

Big Data will play major role as Venter’s team sets out to build world’s largest database of human genotypes, microbiomes and phenotypes

For the second time in recent months, another prominent figure has declared his intention to crack the code of human aging. This time it is scientist and entrepreneur J. Craig Venter, Ph.D., known for his role in sequencing the first whole human genome.

Venter will pursue this goal through a brand new company he launched, called Human Longevity, Inc. (HLI), based in La Jolla, California.

Human Longevity, Inc. Will Compete Against Calico

This is a noteworthy development. Pathologists and clinical laboratory managers already know Venter’s competition in this race is a company called Calico that was founded by several entrepreneurs linked to Google. (more…)

Roche Molecular Gains FDA Clearance for Its Companion Diagnostic Test for New Skin Cancer Drug

Clinical laboratory managers and pathologists can expect more companion diagnostics in responses to advances in molecular knowledge about various diseases

Recently, the Food and Drug Administration (FDA) cleared two products for market, one of which may be of particular interest to anatomic pathologists. The first product is a therapeutic drug for the treatment of late-stage skin cancer. The second product is a companion clinical laboratory test that will be used to identify skin cancer patients most likely to benefit from this new drug.

This development is attracting attention by experts watching the molecular diagnostics marketplace. That’s because both products were developed by the same company on a tight timeline and this process is likely to be much studied by other pharma companies and genetic test developers.

The company that developed the new drug and its companion diagnostic test is Roche Holdings AG (OTCQX: RHHBY). In its press release about the FDA’s decisions, the company simultaneously announced market clearance of the drug Zelboraf (vemurafenib) and the approval of the companion diagnostic, the cobas 4800 BRAF V600 Mutation Test.

Genentech Scientists Zero in on “Liquid Biopsies” as a Way to Replace Tissue Biopsies in Breast Cancer

Surgical pathologists could gain new tool to diagnose many types of cancers

It might soon be possible to determine the HER2 status of breast cancer patients from blood samples rather than tissue biopsies. If this new technology proves feasible, it would give surgical pathologists and medical laboratories a different, and possibly less complex, methodology to use when assessing a case of breast cancer.

In its report about the study, Medscape Medical News, wrote that “HER2 status derived from circulating tumor cells (CTCs) from breast cancer patients was generally concordant with that derived from tumor tissue” and that “CTCs could prove to be an alternative to biopsies for assessing tumor tissue for biomarker status.”


“Poorly-Developed” Clinical Pathology Laboratory Tests Subject of New York Times Story

Times reporter looks at issues affecting accuracy of different breast cancer tests

Pathologists should consider a recent story about breast cancer testing in the New York Times to be a warning flag, similar to the warning flags that the Coast Guard flies along the coast to warn of an approaching hurricane. The subject of the story was “unclear tests” used to identify whether a breast cancer patient is a candidate for certain therapeutic drugs.

The New York Times story was in response to the public release of new guidelines for processing specimens used in estrogen receptor and progesterone receptor (ER/PR) testing for breast cancer. The guidelines were announced by the College of American Pathologists and American Society of Clinical Oncology (ASCO) on April 19, 2010. One goal of the new guidelines is to improve “the accuracy of immunohistochemistry (IHC) testing for the expression status of estrogen (ER) and progesterone receptors (PgR) in breast cancer” as performed by the hundreds of anatomic pathology laboratories in the United States which perform ER and PR testing.