Put It on the Board, 11/14

Any laboratory using the Biothreat-E must still send specimens to an LRN lab or the CDC to rule in or rule out Ebola infection. Details about the emergency use authorization, instructions for use, guidance on interpretation, and more are available from BioFire at http://j.mp/biothreat-e.

Stanford’s Dr. Pinsky says “we are absolutely considering performing the BioFire Biothreat-E assay.” Dr. Pinsky is assistant professor in the Stanford University School of Medicine’s Department of Pathology, as well as in the Department of Medicine’s Division of Infectious Diseases and Geographic Medicine. He estimates it would take a week or two to validate the assay, if appropriate validation materials can be obtained.

“We could get that up and running in a relatively short amount of time, given the immediacy of this potential infection,” Dr. Pinsky says. He adds that he would like to know more about the real-world clinical performance of the assay, given that it was evaluated using specimens spiked with inactivated Ebola Zaire virus.

BioFire’s Scullion notes that the company’s Ebola test for defense applications—the NGDS BT-E assay—will be used as part of the Defense Department’s deployment in West Africa. He says Emory University researchers are expected to publish their clinical experience with the Biothreat-E. Institut Mérieux, a philanthropic organization associated with BioMérieux, plans a study of 300 to 600 West African patient samples, Scullion says.

BioFire Defense’s director of regulated products, Cynthia Phillips, PhD, says that head-to-head evaluations will be done to compare the Biothreat-E with an RT-PCR assay the CDC is using.

“We look forward to seeing those results published,” she says.–KBO’R

LabCorp will buy CRO Covance for $6.1 billion

Laboratory Corp. of America has entered into a definitive agreement to acquire Princeton, NJ-based contract research organization Covance for cash and LabCorp shares valued at $105.12 per Covance share—an equity value of about $6.1 billion.

The aim is for Covance’s risk-based patient monitoring tools to enhance LabCorp’s predictive analytics capabilities to help at-risk patients, risk-bearing physicians, and payers. The combined company will leverage the scale of its central laboratory operations and collective data resources to drive greater research and development productivity for its clients, according to LabCorp.

“There’s not a significant amount of overlap between our businesses,” LabCorp CEO David P. King said in a conference call with investors and reporters. “We are adding approximately $900 million in high-margin central lab revenue to our base. This comes from a new payer, not from our current payer base.”

King promised a “seamless integration of these two companies to create… a real powerhouse in health care services.” He said the acquisition “will position us as the partner of choice for drug development,” due in part to the 650,000 registered LabCorp patients who could be tapped for clinical trial recruitment.

King will serve as CEO of the combined company. The transaction is expected to close in the first quarter of 2015 and is subject to Covance shareholder approval, regulatory approvals, and customary closing conditions.

Chembio’s POC HIV test lands CLIA waiver

The Food and Drug Administration recently granted a CLIA waiver for Chembio Diagnostics’ DPP HIV 1/2 Assay.

The assay detects HIV antibodies in oral fluid or blood and uses the company’s Dual Path Platform technology. The product’s SampleTainer specimen collection bottle is a closed system.

The DPP HIV 1/2 Assay is one of only two FDA-approved, CLIA-waived oral fluid HIV 1/2 rapid tests available in the U.S. The other is made by OraSure Technologies.

$502 price for fecal DNA colorectal cancer test

The Centers for Medicare and Medicaid Services has issued its final National Coverage Determination for Cologuard, making it the first FDA-approved stool DNA test for the detection of colorectal cancer and precancer covered by Medicare. Coverage went into effect immediately, and the CMS has proposed payment of $502 for the test.

The decision was based on a comprehensive review as part of the FDA-CMS parallel review pilot program. Medicare says it will cover the test once every three years for average-risk, asymptomatic patients between 50 and 85 years old. Cologuard has been shown to find 92 percent of colorectal cancers in average-risk patients, with 87 percent specificity.

Biocare acquires CymoGen Dx

Biocare Medical has entered into an agreement to buy New Windsor, NY-based CymoGen Dx.

“CymoGen’s broad product line of next-gen FISH probes for detection of genetic anomalies in tissue samples adds to Biocare’s growing presence in the molecular diagnostics market,” Biocare CEO Roy Yih said in a statement. “Of particular importance are probes PTEN, TMPRSS-ERG, and AR, which will complement Biocare’s leading position in solid tissue IHC prostate markers.”

Biocare’s recently released Oncore Automated Staining platform has the capability to process slide-mounted, formalin-fixed, paraffin-embedded tissue samples through the entire in situ hybridization process.

CMS will cover test for ER+ breast cancer recurrence

BioTheranostics’ Breast Cancer Index test has been awarded Medicare coverage. The CMS posted a positive coverage and reimbursement policy after evaluation by Palmetto GBA, the Medicare administrator responsible for the MolDX molecular diagnostic technology assessment program.

Breast Cancer Index is a molecular genomic test that quantifies the risk of breast cancer recurrence and predicts which patients have a high likelihood of benefiting from extended endocrine therapy. The Medicare policy covers use of the test to predict the five- to 10-year recurrence risk in women with early stage, estrogen receptor-positive breast cancer.

In addition to new claims, Medicare coverage and payment for the Breast Cancer Index will be made retrospectively for previously submitted claims, according to the company.

Beckman, NEB automate NGS applications

Beckman Coulter Life Sciences, in partnership with New England Biolabs, offers automated methods to improve processes and throughput in next-generation sequencing sample preparation. Under the agreement, Beckman will develop, distribute, and support automation for NEB’s NEBNext sample prep reagent kits. NEB will provide technical expertise on the reagents, chemistry, and protocols.

Methods available now are NEBNext Ultra Directional RNA and NEBNext Ultra DNA (including for ChIP-Seq) for Illumina NGS and NEBNext Fast DNA Fragmentation and Library Prep for Ion Torrent. Other methods, including for NEBNext ribosomal RNA depletion and the NEBNext Small RNA reagent kits, are expected to follow.