Therapy Areas: Oncology
Medicare Coverage of CAR T-Cell Therapy Holds Positive Implications for LineaRx
13 August 2019 - - In a decision rendered on August 7, 2019, the Centers for Medicare and Medicaid Services approved chimeric antigen receptor T-cell therapies that fit the CMS criteria for Medicare beneficiaries nationwide, US-based LineaRx, Inc., a majority-owned subsidiary of Applied DNA Sciences, Inc. (NASDAQ: APDN), said.

LineaRx believes its unique method of manufacturing DNA is well poised to benefit from the increasing demand for nucleic-acid dependent therapies, like CAR T, as biotechnology companies pursue their gene and cell therapies with reimbursement assured by the CMS decision.

CAR T-based treatments involve extracting and genetically altering a patient's T cells to attack a protein on the surface of cancer cells. The cells are then infused back into the patient.

All approved CAR T and other redirected cell therapies are manufactured using DNA that is bacterially derived and then delivered to the patient's T cells by a virus.

Such plasmids-based treatments require about three weeks to grow and are acknowledged to have the potential for unintended side-effects.

LineaRx offers a cleaner, potentially higher-performing alternative to plasmid DNAs with linear DNAs produced by PCR (Polymerase Chain Reaction) that are used to reprogram CAR T cells.

LineaRx seeks to commercialize the biotherapeutic value of Applied DNA's deep expertise and experience in the design, manufacture and chemical modification of DNA by large scale polymerase chain reaction.

Linear DNA is a form of DNA distinct from the circular form of DNA most commonly produced in plasmids and grown in bacteria.

Plasmids are extrachromosomal DNA found in bacteria and are associated with the genes for antibiotic resistance which are often exchanged between bacteria and consequentially, are seen by many to embody a serious threat to global health.

In addition, many nucleic acid-based therapies also rely on viral vectors for efficient transfection and expression of plasmid DNA. These viral vectors carry additional nontrivial risks and are extremely time consuming and expensive to manufacture.

LineaRx is a majority-owned Applied DNA Sciences, Inc. (NASDAQ: APDN) company.

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping and pre-clinical nucleic acid-based therapeutic drug candidates.

Applied DNA makes life real and safe by providing innovative, molecular-based technology solutions and services that can help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion.

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Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.