Other

Baxter International Inc.

Alpha Therapeutic Corporation

Ngi/cancer Tech Company, LLC

Peter Schmid

Andrew J Conrad

Charles M Heldebrant

Lorraine B Peddada

Dave S Hoon

A method is provided for identifying viral positive biological fluid donations in the fewest number of test cycles. The method comprises providing biological fluid donations and defining an n-dimensional matrix comprising a multiplicity of elements, each element being identified by a matrix notation comprising an index for each dimension of the array. Samples are taken from each fluid donation and mapped to a matrix element with each sample identified by its corresponding element's notation; n aliquots being taken from each sample and subpools formed from the aliquots with each subpool containing an aliquot from all samples mapped to elements in which one of the dimensional indices is fixed. Subpools are tested for viral indication and the dimensional index of each subpool that returns a positive viral indication is determined. The dimensional indices are combined to identify a subset of matrix elements that contain a viral positive sample.

Efficient algorithm for PCR testing of blood samples

Systems, processes, and devices are provided which are useful for testing blood or plasma donations to detect those specific donations which are contaminated by a virus above a predetermined level. An apparatus and process is described which forms individual, separately sealed and connected sample containers from a flexible hollow tubing segment connected to a fluid donation container. The tubing segment is sealed at spaced-apart intervals along its length, with tubing segment portions in the intervals between the seals defining containers, each of which holds a portion of a plasma sample. The contents of the containers are formed into pools which are subsequently tested for virus contamination by a high-sensitivity test such as PCR. The pools are tested in accordance with an algorithm by which a sample from each donation is mapped to each element of an N-dimensional matrix or grid. Each element of the matrix is identified by a matrix identifier, X , where rcs defines the dimensional index. An aliquot is taken from each sample, and subpools are formed, each subpool comprising aliquots of samples in which one dimensional index is fixed. All of the subpools are tested in one PCR test cycle. The dimensional indicia of each positive subpool is evaluated mathematically in accordance with a reduction by the method of minors, thereby unambiguously identifying a unique element in the grid, thereby unambiguously identifying a uniquely positive blood or plasma donation.

Methods for detecting metastasis of melanoma and breast cancer cells, detecting subclinical metastasis, and monitoring treatment are disclosed. Kits for use in such methods also are disclosed. The methods provide for the detection of nucleic acids corresponding to multiple melanoma or breast cancer specific markers using template dependent amplification processes. Methods using multiple markers provide increased sensitivity over existing methods.

Detection of melanoma or breast metastasis with a multiple marker assay

An apparatus and method for attaching a labeled probe to macromolecules such as DNA/RNA fragments or proteins attached to a membrane utilizes a flexible bag having an inlet and an outlet port. Reagents including the probe to which the membrane is to be exposed during the labeling process are stored in reservoirs. Pumps are provided to selectively transfer reagents from reservoirs to the inlet port and for selectively evacuating the bag via the outlet port so that reagents from the individual reservoirs can be sequentially supplied to or removed from the bag while the membrane is positioned therein. One or more rollers are arranged to roll back and forth over the top of the bag to uniformly expose the membrane to the reagent within the bag.

Apparatus for attaching a labeled probe and/or antibody to macromolecules

An automated electrophoresis and transfer apparatus for separating macromolecules in accordance with their molecular weight and transferring the same to a transfer membrane includes a housing having a perforated intermediate horizontal partition defining an upper reservoir and a lower chamber. A pair of spaced electrodes are provided for generating a horizontal electrical field. A pump is connected between a plurality of containers and the reservoir for sequentially pumping the chemical solutions within the container into the reservoir. A transfer membrane is positioned over the partition and an impermeable sheet is interposed between the membrane and the gel member and withdrawn prior to the transfer operation. A pump provides a small over pressure within the lower chamber which in cooperation with the impermeable sheet substantially prevents chemical solutions from penetrating the transfer membrane prior to the transfer operation. A vacuum pump provides a low pressure within the lower chamber and a pair of vertically spaced electrodes provides a vertical electrical field across the gel member and transfer membrane during the transfer operation.

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Los Angeles, CA, United States of America

Peter Schmid